Angioplasty.Org
Most Popular Angioplasty Web Site
    Angioplasty.Org
News Center
Features, Commentary, Interviews, Company News
Email Bookmark and Share
If you wish to view news by a specific topic or date range, select from the following menu:

April 21, 2015
Medtronic Begins Enrollment in Feasibility Study of Valiant 'Mona LSA' Branch Thoracic Stent Graft System
Medtronic's Valiant® Mona LSA System Thoracic Stent Graft System
Medtronic plc (NYSE: MDT) announced the start of a new feasibility study to evaluate the safety and effectiveness of the Valiant Mona LSA branch thoracic stent graft system, an investigational device designed to enable a completely endovascular solution for aortic aneurysms encroaching on the left subclavian artery (LSA). Cleveland Clinic cardiothoracic surgeon Dr. Eric Roselli successfully completed the first implant in the study on Thursday.

April 12, 2015
iFR and iFR Scout to be Featured in Live Case from Hammersmith
image
Commentary from the Editor's Blog: If you've been wondering what iFR (Instant wave-Free Ratio) is, how it works, how it compares to FFR (Fractional Flow Reserve) and, most importantly, how it affects clinical outcomes, then click here to register for a free, online, interactive live case being done on Monday, April 13, 2:30pm-3:30pm London Time, 9:30am-10:30am New York Time).

March 31, 2015
Medtronic CoreValve® System Receives FDA Approval for Transcatheter Valve-In-Valve Procedures
Medtronic CoreValve® Evolut™ in a surgical bioprosthetic valve (
Medtronic plc (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) approval of the CoreValve® System for valve-in-valve (VIV) procedures in patients whose surgical aortic heart valves have failed. The CoreValve System is the first transcatheter heart valve approved in the U.S. for VIV procedures in both high and extreme risk patients who have limited options or may otherwise go untreated.

March 30, 2015
Medtronic Announces Japanese Regulatory Approval of CoreValve® System
Dr. Yoshiki Sawa
Medtronic plc (NYSE: MDT) today announced Japanese regulatory approval for the self-expanding transcatheter CoreValve® System for patients with severe aortic stenosis (AS) unable to undergo surgery, and for whom treatment with the CoreValve is determined to be the best option. Japanese regulatory authorities granted approval of the CoreValve system for transcatheter aortic valve implantation (TAVI) based on robust data from the CoreValve U.S. Pivotal Trials and the Medtronic CoreValve Japan Trial, which is the first study to evaluate a self-expandable transcatheter valve in the Japanese patient population.

March 30, 2015
Philips Appoints Healthcare Industry Veteran Robert Cascella to Lead Its Cluster of Global Imaging Businesses
Philips Headquarters in Amsterdam
Royal Philips (NYSE: PHG, AEX: PHIA) today announced the appointment of Mr. Robert Cascella to lead Philips' multi-billion euro cluster of Imaging businesses. These businesses capitalize on the rapidly transforming global healthcare industry, in particular in the areas of integrated diagnostic imaging and image-guided minimally invasive therapy solutions. He succeeds Gene Saragnese, who has decided to retire from Philips per May 1, 2015. Mr. Cascella will hold the title of Executive Vice President, Royal Philips.

March 20, 2015
ACC Reacts to CMS' Proposed Rule for Meaningful Use Stage 3
logo of The American College of Cardiology
American College of Cardiology President Kim Allan Williams Sr., M.D., FACC, released the following statement on today's announcement by the Centers for Medicare & Medicaid Services regarding Meaningful Use Stage 3: "The American College of Cardiology has long supported the adoption of electronic health records (EHRs) as a mechanism for improving patient outcomes. The EHR Incentive Program as currently structured has been focused more on 'checking the box' than changing care delivery to achieve the goal of improved patient care.

March 15, 2015
Medtronic CoreValve® System Sustains Superior Survival Benefit Over Open Heart Surgery at Two Years
Medtronic's CoreValve
Medtronic plc (NYSE: MDT) today unveiled new, highly anticipated two-year data from the High Risk Study of the CoreValve U.S. Pivotal Trial, which continued to show superior survival benefit at two years for transcatheter aortic valve replacement (TAVR) with the CoreValve® System compared to patients who underwent surgical aortic valve replacement (SAVR). The CoreValve US Pivotal High Risk Study is the first and only head-to-head study to show statistically significant survival differences favoring TAVR in aortic stenosis patients who are considered high risk for surgery.

March 14, 2015
Medtronic CoreValve® Evolut™ R System Yields Exceptional Outcomes in First Clinical Study
CoreValve Evolut R
Medtronic plc (NYSE: MDT) today announced initial clinical outcomes for its next-generation CoreValve® Evolut™ R System. At 30-days, the new recapturable, self-expanding valve showed no incidents of all-cause mortality or stroke in a high and extreme risk patient population. Data from the Evolut R Study, which enrolled 60 patients from six centers in the United Kingdom, Australia and New Zealand, were unveiled today at the 64th Annual Scientific Session of the American College of Cardiology (ACC.15).

March 14, 2015
SCCT Statement on the PROMISE Clinical Trial Presented at the ACC Scientific Sessions
SCCT logo
At the American College of Cardiology (ACC) Annual Scientific Sessions in San Diego, results from the keenly anticipated PROMISE clinical trial confirmed what many cardiologists and radiologists have long suspected to be true: coronary computed tomographic angiography (coronary CTA) is extraordinarily effective in accurately diagnosing patients with low to moderate chest pain. In most cases, coronary CTA is at least as effective as diagnostic methods such as stress tests such as SPECT myocardial perfusion imaging.

March 14, 2015
Medtronic Begins Testing a "Drug-Filled Stent"
Medtronic's Drug-Filled Stent
Today Medtronic announced the first study of a novel stent concept, the "drug-filled stent" or DFS. It is both a drug-eluting stent AND a bare metal stent, utilizing a stent construction that Medtronic currently uses in its Resolute Integrity and Onyx stents. The stent is fashioned from a single strand of metal that can have several "inner cores." In the DFS, the drug is contained in a reservoir, inside the stent, and slowly eluted through small holes in the metal outer core.

March 12, 2015
Volcano Receives CE Mark for iFR Scout Pullback Software to Help Diagnose Serial Lesions and Diffuse Coronary Disease
Dr. Javier Escaned
Royal Philips (NYSE: PHG; AEX: PHIA), today announced that Volcano, a Philips business, has received CE Mark for the iFR Scout pullback software, a functional extension of its existing iFR Modality, optimized to assess serial lesions and diffuse coronary disease. Limited Market Release will commence immediately at leading European and Japanese medical centers. This software is currently pending 510(k) clearance at the US FDA. It is not available for sale in the US.

March 12, 2015
Medtronic Begins Trial for Next-Generation Drug-Eluting Stent in Small Arteries
Medtronic Resolute Onyx stent picture on map of U.S.
Today Medtronic plc (NYSE: MDT) announced that it is beginning the U.S. pivotal trial for its new drug-eluting stent, the Resolute Onyx™. The Onyx received the European CE Mark in November and has been available in countries that recognize the CE Mark. The first phase of this trial will be studying one of the most challenging clinical scenarios: blockages in arteries that measure as small as 2.0mm. Normally drug-eluting stents are not used in arteries this narrow because of the increased incidence of stent thrombosis and restenosis. But the Onyx has thinner struts than the first and second generation DES devices and has shown positive outcomes in these narrow vessels.

March 11, 2015
Consumer Reports Overstates Cardiac CT Radiation Dose
Cardiac CT 3D image
Consumer Reports regularly publishes health information to aid the consumer/patient in making decisions. And that's a good thing. But also important is having the most current information, which their January 27, 2015 article, titled "The surprising dangers of CT scans and X-rays," does not. I'm talking about the radiation dose from a Cardiac CT scan. The article states that a Cardiac CT Angiogram (CTA) exposes the patient to 12 mSv of ionizing radiation, or 120 times that of a chest X-ray. This was true years ago, when CTA was first being used to diagnose coronary artery disease. But it is not true today.

February 27, 2015
Society of Cardiovascular Computed Tomography (SCCT) Names Norm Linsky New Executive Director
Norm Linsky
The Society of Cardiovascular Computed Tomography (SCCT) Board of Trustees today announced that Norm Linsky, MPA, MA has been selected as the Society's new Executive Director. Linsky comes to SCCT from the Society for Cardiovascular Angiography and Interventions (SCAI), where as Executive Director for 14 years he partnered with physician volunteers to dramatically increase SCAI's membership, educational programs, advocacy efforts, guidelines and international partnerships.

February 26, 2015
Medicare Approves Drug-Coated Balloons for Outpatient Leg Angioplasty
Lutonix and IN.PACT drug-coated balloons
Last week saw the U.S. Centers for Medicare and Medicaid Services (CMS) approve reimbursement for the two drug-coated balloons that recently were approved by the FDA: C. R. Bard's Lutonix and Medtronic's IN.PACT. Both devices have shown superior results when compared to uncoated balloons (a.k.a. "plain old balloon angioplasty" or POBA). The reimbursement approval from Medicare is crucial to the success of these medical devices so that patients can actually benefit from them.

February 19, 2015
Medicare Approves Transitional Pass-Through Payment for Outpatient Use of Medtronic Drug-Coated Balloon
IN.PACT Drug-Coated Balloon
The U.S. Centers for Medicare and Medicaid Services (CMS) has approved a transitional pass-through payment for Medtronic's IN.PACT Admiral drug-coated balloon (DCB) under the Medicare hospital outpatient prospective payment system (OPPS), removing a potential barrier to patient access to this new medical device, which represents a significant improvement to the standard of care for peripheral arterial disease in the upper leg.

February 19, 2015
CMS Approves Pass-Through Payment for Lutonix DCB for Outpatient Use
Lutonix Drug-Coated Balloon
The U.S. Centers for Medicare and Medicaid Services (CMS) has approved a pass-through payment for C. R. Bard's Lutonix® drug-coated balloon (DCB) under the Medicare hospital outpatient prospective payment system. This approval follows a unanimous favorable recommendation from the FDA's Circulatory Systems Devices Advisory Panel, which voted 9 to 0 on each question of safety, efficacy and benefit/risk.

February 17, 2015
Philips Acquisition of Volcano Completed
Frans van Houten, CEO, Royal Philips
As expected, Royal Philips (NYSE: PHG; AEX: PHIA) today completed its acquisition of San Diego-based Volcano Corporation, making Philips the only manufacturer of cardiovascular imaging systems to offer both angiographic (X-ray) and intravascular imaging and guidance options. The combination of Volcano's IVUS and FFR technology, along with Philips long-standing leadership in the interventional imaging field, promises to bring wider distribution of image-guided therapies.

February 16, 2015
Medtronic Gains CE Mark for Euphora Semicompliant Coronary Balloon; Launches in Europe
Euphora™ Semicompliant Balloon Dilatation Catheter
Today Medtronic plc (NYSE: MDT) announced that its Euphora™ Semicompliant Balloon Dilatation Catheter has received the CE (Conformité Européene) mark and that the product has been launched, the first case being performed by Dr. Richard Edwards in the UK. While most think of stents when they think of interventional cardiology, balloons play an important role in percutaneous coronary interventions (PCI).

February 15, 2015
Clinton and Eisenhower: Presidents, Hearts, Stents and 55 Years
Presidents Bill Clinton and Dwight Eisenhower
From the archives: It's Presidents' Day weekend, so we're putting up this 2010 blog which examined how the treatment of heart disease changed in the time between these two U.S. Presidents, from basically watching and waiting to intervention that can reduce damage to the heart muscle. Also includes an update on some Washingtonians who have had them since.

February 15, 2015
Svelte and ASAHI INTECC to Collaborate on Fixed Wire Stent System; Ideal for Transradial Approach
Svelte Acrobat (R) w/standard stent (L)
Svelte Medical Systems, Inc., manufacturers of the unique drug-eluting coronary stent fixed wire Integrated Delivery System (IDS), sometimes called a "stent-on-a-wire," and ASAHI INTECC, the top Japanese maker of guidewires used in interventional procedures, have announced a manufacturing and co-promotion agreement. ASAHI will design and manufacture the wire tip of the Svelte IDS stent, using its latest ACTONE technology, and also will be partnering with Svelte in the stents promotion.

February 13, 2015
The American Heart Association - American Stroke Association and Medtronic Collaborate to Reduce Recurrent Strokes
AHA-ASA and Medtronic logos
The American Heart Association/American Stroke Association (AHA/ASA) and Medtronic plc (NYSE: MDT), today announced a collaboration to reduce the rate of recurrent strokes in the U.S. The two organizations will work together over several years to educate, raise awareness and support effective management of patients who have strokes, one of the most devastating diseases affecting Americans today. The initiative, announced at the American Stroke Association's annual International Stroke Conference in Nashville, Tennessee, will focus on reducing strokes of unknown cause, called "cryptogenic stroke."

February 11, 2015
Medtronic Insertable Cardiac Monitors Detect Atrial Fibrillation in Stroke Patients in 'Real-World' Study
Medtronic's Reveal LINQ Insertable Cardiac Monitor
Medtronic plc (NYSE: MDT), today announced the results of a new "real-world" study of patients who have had a cryptogenic stroke (stroke of unknown cause), in which the Reveal LINQ™ Insertable Cardiac Monitor (ICM) detected atrial fibrillation in everyday practice at an even greater rate than that found in a recent, rigorously-conducted clinical trial (the CRYSTAL AF Study, which was published in The New England Journal of Medicine).

February 10, 2015
Boston Scientific to Distribute Bard's Lutonix Drug-Coated Balloon for Blockages in Leg Arteries
Lutonix Drug-Coated Balloon
Boston Scientific (NYSE: BSX) and C. R. Bard, Inc. (NYSE: BCR) have announced that Bard's Lutonix® 035 drug-coated balloon will be distributed in the United States by Boston Scientific. The specific terms of the agreement were not disclosed. The Lutonix was the first drug-coated balloon (DCB) approved by the FDA for use in the superficial femoral or popliteal arteries in the leg.

February 6, 2015
The National Board of Physicians and Surgeons (NBPAS) Expands Certification Program
The National Board of Physicians and Surgeons (NBPAS) logo
The National Board of Physicians and Surgeons (NBPAS) has responded to the apology issued to the medical professions earlier this week by the American Board of Internal Medicine (ABIM) about its Maintenance of Certification (MOC) program by expanding its own alternative certification program "to most of the American Board of Medical Specialties (ABMS) non-surgical specialties."

February 5, 2015
Medtronic Launches Drug-Coated Balloon for Peripheral Artery Disease in U.S.
IN.PACT Admiral Drug-Coated Balloon
Medtronic plc (NYSE: MDT) announced yesterday that its IN.PACT Admiral drug-coated balloon (DCB), approved last month by the FDA, is now available for use in the U.S. The first uses of this new addition to the interventional armamentarium were in New York, Michigan, Arizona, and Louisiana. The IN.PACT Admiral is the second such device approved by the FDA, the first being Bard's Lutonix back in October.

February 5, 2015
Philips Extends Tender Offer Until February 17 to Acquire Volcano
Volcano and Philips logos
Royal Philips (NYSE: PHG; AEX: PHIA) and Volcano Corporation (NASDAQ:VOLC) today announced that Philips' indirect wholly owned subsidiary Clearwater Merger Sub, Inc. is extending the expiration date for its previously announced tender offer until 9:00 a.m., Eastern Time, on February 17, 2015, for all outstanding shares of common stock of Volcano for USD 18.00 per Volcano share, without interest, less any applicable withholding of taxes.

February 5, 2015
Medtronic Gets CE Mark for Larger Sizes of CoreValve
Medtronic's CoreValve Evolut R
Two larger sizes of the CoreValve Evolut R System are now available in Europe, according to Medtronic plc (NYSE: MDT). Conformité Européene approval (CE Mark) has been granted to these new device sizes of 26mm and 29mm, expanding the range of patients that can be treated with this next generation TAVI platform. These new sizes utilize an extending skirt designed to further promote valve sealing at the annulus in order to reduce paravalvular leak.

February 4, 2015
Who's Sorry Now? The ABIM, That's Who
Sad puppy with ABIM logo
Commentary from the Editor's Blog: The American Board of Internal Medicine (ABIM) apologized to the medical community today saying they "had gotten it wrong." What the ABIM had gotten "wrong" was the Maintenance of Certification (MOC) changes passed a year ago. Many physicians had objected to what they felt were onerous, time-consuming, worthless and expensive requirements.

Feberuary 3, 2015
ABIM Announces Immediate Changes to MOC Program
ABIM logo
Today, the American Board of Internal Medicine (ABIM) announced substantial changes to its Maintenance of Certification (MOC) program and indicated a desire to work more closely with the internal medicine community. ABIM President and CEO Richard J. Baron, MD, reached out to diplomates via e-mail to open a conversation on how to improve MOC.

January 29, 2015
Philips Extends Tender Offer Period to Acquire Volcano
Volcano and Philips logos
Royal Philips (NYSE: PHG; AEX: PHIA) and Volcano Corporation (NASDAQ:VOLC) today announced that Philips' indirect wholly owned subsidiary Clearwater Merger Sub, Inc. is extending the expiration date for its previously announced tender offer until 12:00 midnight, Eastern Time, on February 5, 2015 (one minute after 11:59 p.m., Eastern Time, on February 4, 2015) for all outstanding shares of common stock of Volcano for USD 18.00 per Volcano share, without interest, less any applicable withholding of taxes.

January 28, 2015
CoreValve: Survival and Safety Advantages Compared to Open Surgery for Patients with Prior CABG
CoreValve (artist rendition)
A new sub-analysis of 226 patients from the CoreValve High Risk Study showed benefits over surgical aortic valve replacement (SAVR) for high risk patients who had received CABG prior to their valve replacement procedure. The primary endpoint of all-cause mortality or major stroke at one-year was 11.4% in the TAVR group vs. 21.8% for SAVR group, and reached significance with a p value of 0.04.

January 27, 2015
FDA Approves Medtronic's Melody Transcatheter Pulmonary Valve
Melody Transcatheter Valve
This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

January 26, 2015
Medtronic Completes Acquisition of Covidien
Medtronic and Covidien logos
Medtronic plc (NYSE: MDT), a global leader in medical technology, services and solutions, announced today that it has successfully completed the previously announced acquisition of Covidien plc (NYSE: COV). Under the terms of the acquisition agreement, Medtronic, Inc. and Covidien plc are now combined under Medtronic plc. Shares of Medtronic plc are expected to begin trading on the New York Stock Exchange (NYSE) under the symbol "MDT" on Tuesday, January 27, 2015.

January 26, 2015
Medtronic's Acquisition of Covidien Approved by Irish High Court; Anticipated to Close on January 26, 2015
Medtronic and Covidien logos
Medtronic, Inc. (NYSE: MDT) and Covidien plc (NYSE: COV) today announced that the Irish High Court has sanctioned the Covidien scheme of arrangement pursuant to which Medtronic will acquire Covidien under a new holding company incorporated in Ireland to be named Medtronic plc. With the Court's approval of the scheme of arrangement, Medtronic and Covidien anticipate that the transaction, which will result in Medtronic, Inc. and Covidien plc becoming wholly owned subsidiaries of Medtronic plc, will close later today.

January 26, 2015
Dr. Robert Califf named FDA Deputy Commissioner for Medical Products and Tobacco
Dr. Robert Califf
U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D., today appointed Robert Califf, M.D., a recognized global leader in cardiology, clinical research, and medical economics, as FDA Deputy Commissioner for Medical Products and Tobacco. In this position, Dr. Califf will provide executive leadership to the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Healthand the Center for Tobacco Products.

January 21, 2015
Opsens Fiber Optic System Utilized by FFR Pioneers in Europe and Japan
Opsens' OptoWire for FFR
Opsens Inc. (TSXV:OPS) recently announced that its innovative entry into the fractional flow reserve (FFR) market, the OptoWire and OptoMonitor, received its first use in Europe. The OptoWire system was granted CE Mark approval back in November. And the first use of this new system was significant in that the operator was one of the "founding fathers" of FFR, Dr. Bernard De Bruyne of the Cardiovascular Center Aalst in Belgium.

January 15, 2015
NBPAS Launches Alternative to MOC
logo of The National Board of Physicians and Surgeons (NBPAS)
Commentary from the Editor's Blog: Today's the day that The National Board of Physicians and Surgeons (NBPAS) officially launches. Briefly stated, it's an alternative certification organization, set up by Dr. Paul Teirstein and a group of physicians, mostly cardiologists, who strongly objected to the Maintenance of Certification assessment track established by the American Board of Internal Medicine (ABIM).

January 8, 2014
Scalpel…Suture…Suction…Pencil?
Standardized test and operating room
Commentary from the Editor's Blog: The concept of Maintenance of Certification (MOC) was to ensure that physicians who had been certified in their specialty kept current with medical practice and the current guidelines. It's not that concept that Dr. Paul Teirstein objects to, but its heavy-handed implementation by, as he puts it, "people not directly involved in patient care who have lost contact with the realities of day-to-day clinical practice." Ouch!

January 6, 2014
New Treatment for Peripheral Artery Disease is Approved by the FDA
Drs. Zeitler, Gruentzig, and Dotter
Commentary from the Editor's Blog: It was 51 years ago that Charles Dotter first opened a blockage in the superficial femoral artery using catheters. He invented angioplasty, coined the term, and began a revolution, but it wasn't until recently that the dream of a non-surgical durable way of treating peripheral artery disease came to fruition. With the Lutonix approved last October and Medtronic's IN.PACT drug-coated balloon approved yesterday, a new era has begun.

January 6, 2015
FDA Approves Medtronic Drug-Coated Balloon for Treating Peripheral Artery Disease in the Upper Leg
Upper leg arteries (superfiical femoral and popliteal)
Medtronic, Inc. (NYSE: MDT) has announced that the FDA has approved its drug-coated balloon (DCB), the IN.PACT Admiral, for the treatment of peripheral artery disease (PAD) in the upper leg. The IN.PACT Admiral is the second such device approved by the FDA, the first being Bard's Lutonix back in October. The FDA approval of the IN.PACT was supported by a body of clinical evidence of 21 studies involving more than 3,500 patients worldwide, demonstrating the best clinical outcomes of any medical technology for the treatment of PAD in the SFA and popliteal arteries.

December 22, 2014
Medtronic Drug-Coated Balloon for Peripheral Artery Disease Tops Standard Balloon Angioplasty in Landmark Study
IN.PACT Admiral Drug-Coated Balloon
The results of a landmark study published this month in Circulation, the world's leading cardiovascular journal, indicate that a novel medical device from Medtronic, Inc. (NYSE: MDT) called the IN.PACT Admiral drug-coated balloon (DCB) significantly outperformed standard balloon angioplasty in the treatment of symptomatic peripheral artery disease in the upper leg -- specifically, the superficial femoral and proximal popliteal arteries.

December 19, 2014
Philips Buys Volcano: It's About Money, Technology, and History
Volcano and Philips logos
Commentary from the Editor's Blog: The acquisition of Volcano by Philips is a landmark event in the world of imaging. For years, Volcano's mantra was "angiography alone is not enough." Well now, angiography agrees and one of the largest manufacturers of cath labs will be offering IVUS, FFR and iFR modalities as part of its total imaging package. The potential spread of these technologies can only benefit patients, with better outcomes and more targeted procedures, and also save hospitals and healthcare systems money.

December 17, 2014
Philips to Acquire Volcano to Expand Global Leadership Position in Image-Guided Therapy Market
Volcano and Philips logos
Royal Philips (NYSE: PHG; AEX: PHIA) and Volcano Corporation (NASDAQ:VOLC), a global leader in catheter-based imaging and measurement solutions for cardiovascular applications, today announced that they have entered into a definitive merger agreement. Pursuant to the agreement, Philips will commence a tender offer to acquire all of the issued and outstanding shares of Volcano for USD 18.00 per share, or a total equity purchase price of USD 1 billion (approx. EUR 800 million), to be paid in cash upon completion. The board of directors of Volcano has unanimously approved the transaction and recommends the offer to its shareholders. The transaction is expected to close in the first quarter of 2015.

December 16, 2014
Volcano: 1,000 iFR Systems in Use Worldwide
graphic of iFR
Volcano Corporation (NASDAQ: VOLC) has announced that 1,000 iFR ((instant wave-Free Ratio™) systems have now been activated worldwide. iFR was approved by the U.S. FDA in March of this year and is being used increasingly in cath labs to assist in decision-making (to stent or not to stent and, if so, which blockage is the correct one to stent).


December 9, 2014
Excellent Long-Term Outcomes for Endovascular Aneurysm Repair with Medtronic's Endurant AAA Stent Graft
Medtronic's Endurant AAA Stent Graft
New long-term data from two different studies of Medtronic's Endurant AAA stent graft system reinforce earlier outcomes and demonstrate lasting and consistent results for the endovascular repair of abdominal aortic aneurysms (EVAR). In the U.S. IDE study, 99.2% of patients were free from aneurysm-related mortality and 90% were free from secondary interventions at four years. Similar outcomes were seen In the ENGAGE Registry, even though there were differences in eligibility criteria, including patients with more complex baseline characteristics. (Article includes a video clip about the 1st EVAR performed in 1990.)

December 1, 2014
From Bench to Bedside to Bench Revisited: Supreme Court Justice Ginsburg Back in Action
Ruth Bader Ginsburg
Almost two decades ago, interventional cardiology pioneer Dr. Spencer B. King III penned an article for Circulation titled, "Angioplasty From Bench to Bedside to Bench." Dr. King's article was a recounting of the history of the development of the angioplasty balloon catheter by his colleague at Emory University, Andreas Gruentzig. This morning, the title of his article took on new meaning, as Supreme Court Justice Ruth Bader Ginsburg entered the courtroom and took her seat, engaging in several complex legal arguments concerning mortgage loan officers, Facebook threats, and more.

November 27, 2014 (updated from November 26)
Supreme Court Justice Ginsburg Released From Hospital, One Day After Receiving Stent
Ruth Bader Ginsburg
Supreme Court Justice Ruth Bader Ginsburg, 81, was released from the hospital this morning, one day after a stent was placed in her right coronary artery (RCA). According to yesterday's official statement from the Supreme Court, "The coronary blockage was discovered after Justice Ginsburg experienced discomfort during routine exercise last night and was taken to the hospital. She is resting comfortably and is expected to be discharged in the next 48 hours." It was only 24 hours.

November 26, 2014
Medtronic Acquisition of Covidien Receives U.S. FTC Clearance
Omar Ishrak, Medtronic CEO
Medtronic, Inc. (NYSE: MDT) and Covidien plc (NYSE: COV) today announced the receipt of U.S. Federal Trade Commission (FTC) clearance of Medtronic's proposed acquisition of Covidien. The FTC's clearance follows Medtronic's and Covidien's agreement to a proposed consent order, which includes a commitment to divest certain assets related to Covidien's drug-coated balloon catheter product. Medtronic's acquisition of Covidien is expected to close in early 2015 after receipt of certain additional regulatory clearances and approvals by both companies' shareholders and sanction by the High Court of Ireland.

November 26, 2014
FDA Approves HeartFlow FFR-CT: Non-Invasive Method for Determining Coronary Ischemia
HeartFlow FFRct 3D Analysis
The FDA today approved HeartFlow's FFR-CT software for measuring coronary blockages non-invasively. The current accuracy of FFR-CT to correctly differentiate significant blockages from those not needing revascularization is only in the mid-80% range. Yet the fact that a CT scan can be performed quickly, non-invasively, and with relatively low radiation doses, makes this procedure a significant contender to the extremely common nuclear stress test, and a potential game-changer in the diagnosis of coronary artery disease.

November 21, 2014
One Year Data from the EVOLVE II Trial Shows Safety and Efficacy for Boston Scientific's SYNERGY Bioabsorbable Polymer Stent
SYNERGY™ Bioabsorbable Polymer Stent
One of the last late breaking clinical trials to be presented at this year's American Heart Association Scientific Session may prove to be the pivotal trial of the first bioabsorbable polymer stent technology available to patients in the U.S., if approved by the FDA. Presented by Dr. Dean J. Kereiakes, medical director, The Christ Hospital Heart & Vascular Center/The Lindner Research Center, Cincinnati, Ohio, the one year data from the EVOLVE II Clinical Trial of Boston Scientific's investigational SYNERGY™ Bioabsorbable Polymer Stent, showed very low rates of target lesion failure (6.4%) and stent thrombosis (0.4%).

November 20, 2014
Encouraging Results for Aorfix AAA Stent Graft from Lombard Medical
AORFIX™ Endovascular Stent Graft
Today, a relatively new player in the field, Lombard Medical, announced two year efficacy and safety data on their Aorfix endovascular stent graft system which received FDA approval in 2013 and has been used in more than 4,000 procedures worldwide. The highlights of the data showed 100% freedom from aneurysm rupture, 98% freedom from Type I & III endoleaks and 99% freedom from device migration. In other words, the Aorfix stent graft fixed the problem, rarely developed a leak, and didn't move - all issues that existed with the very first generation of stent grafts, but which have decreased with each iteration of new stent graft designs to the point where EVAR is now considered the equal of surgery.

November 18, 2014
The Beginnings of Endovascular Abdominal Aortic Aneurysm Repair (EVAR)
Dr. Frank J. Veith
Today was day one of the 41st Annual Veith Symposium in New York City. The whole field of endovascular repair and intervention has grown exponentially since the first endovascular repair of an abdominal aortic aneurysm (EVAR) was performed by Dr. Juan Parodi in 1990, but it took quite some time to be accepted as a standard of care. Today the endovascular approach is the preferred procedure to repair an AAA and this is because of the advances in medical device design and manufacturing and the dedication of physicians to this less invasive non-surgical approach, physicians who will be attending this year's Veith Symposium.

November 16, 2014
DAPT Study: Extended Treatment After Stenting Lowers Stent Thrombosis and Heart Attacks
Stent and pills
"Longer is better." That's what Dr. Dean Kereiakes told Angioplasty.Org when characterizing the results of the long-awaited Dual Antiplatelet Therapy (DAPT) study, which were presented today at the annual American Heart Association Scientific Sessions in Chicago. Dr. Kereiakes is the co-principal investigator for this five year study of 10,000 patients, which adds to the knowledge base of whether long-term treatment with aspirin and a thienopyridine, such as Plavix, after stent implantation is beneficial to patients.

November 16, 2014
Plavix and Aspirin After Stent: 8 Years Later – Is Longer Better?
Plavix and stent
No one thought it would take quite so long to get this information, but in just a couple hours results from the Dual Antiplatelet Therapy (DAPT) Study will be presented at the American Heart Association Scientific Sessions 2014. The question to be answered: Is there a benefit to extending dual antiplatelet therapy (aspirin plus a thienopyridine, such as clopidogrel/Plavix, prasugrel/Effient, etc.) beyond one year after stenting?

November 14, 2014
New AAA Stent Graft Approval for Medtronic
Endurant IIs AAA stent graft from Medtronic
Medtronic, Inc. (NYSE: MDT) has announced the U.S. and European approval and launch of its latest stent graft system for the endovascular repair of abdominal aortic aneurysms: the Endurant IIs. This newest iteration of the widely-used Endurant endograft (nearly 1 out of every 2 procedures are done with the Endurant) features a three-piece system with a shorter ipsilateral leg, allowing the device to accommodate more anatomical variations.

November 14, 2014
Medtronic Sponsors American Diabetes Association Educational Campaign "Make the Link" for 2nd Year
American Diabetes Association and Medtronic logos
To help educate people about this connection with heart disease, and provide materials to help with prevention, as well as treatment, Medtronic has announced that it is continuing its sponsorship of the American Diabetes Association's Make the Link! Diabetes, Heart Disease and Stroke initiative for a second year. The "Make the Link" website has a series of downloadable information packets to help educate people about diabetes and coronary artery disease (CAD).

November 11, 2014
Vascular Surgery and the Battlefield: Honoring Our Veterans
M.A.S.H. unit
Today is Veterans Day in the U.S., honoring the soldiers who fought in the country's wars. Last week was the VIVA 14 meeting, presenting the latest advances and techniques in endovascular repair and therapy of blood vessels. These two events are actually closely aligned: the development and advances made in vascular surgery, and now endovascular therapies, were pioneered on the battlefield.

November 6, 2014
Fractional Flow Reserve: Measuring Pressures in the Marketplace
Andreas Gruentzig in cath lab
The FFR market has been a duopoly, split almost evenly between St. Jude Medical and Volcano Corporation. While these companies compete with each other, both have expressed upon occasion that the real challenge to increasing their sales and profits is not in gaining share from each other, but from expanding the field of FFR as a whole. However, some new smaller device companies are beginning to enter the marketplace. And the technology is slightly different: instead of pressure wires, these newer systems are utilizing fiber-optics.

November 5, 2014
Crazy Charlie's Amazing Idea: Angioplasty at 50
Charles Dotter in LIFE magazine 1964
Crazy Charlie: the nickname given to Dr. Charles Dotter by the vascular surgeons who knew him and his work at Oregon Health Sciences University in Portland — and who did not like what he was doing. Unblocking arteries in the leg without surgery? From the inside, using catheters? Crazy! So that was 50 years ago, and to call Dotter a visionary is a vast understatement because this week, radiologists, cardiologists and surgeons have gathered at the VIVA 14 meeting to present and hear the latest information, late-breaking trials and reports on vascular interventional therapies, and see demonstrations of an array of devices and techniques.

November 4, 2014
5-Year Data for Zilver PTX Drug-Eluting Stent for Leg Arteries Show Continued Efficacy
Cook's Zilver PTX Drug-Eluting Stent
Following up on the presentation of 4-year data for the Zilver PTX drug-eluting stent at last year's VIVA meeting, Cook Medical today announced the 5-year outcomes - and the results show that patients arteries have remained open, and that there has been no "late catch-up" with the Zilver. While patency was slightly lower at the 5-year mark than at 4-years for both the Zilver and standard balloon due to disease progression and other causes, the divergence between the two therapies actually grew from year 4 to 5, favoring the Zilver.

November 4, 2014
Medtronic's IN.PACT Drug-Coated Balloon Shows Safety and Efficacy for Peripheral Angioplasty in Diabetics
IN.PACT Admiral Drug-Coated Balloon
Data presented this morning at the VIVA 14 meeting in Las Vegas, Nevada, showed that patients treated with Medtronic's IN.PACT Admiral drug-coated balloon (DCB) for narrowings in their legs above-the-knee had significantly better outcomes than those treated with the standard "plain" balloon catheter. While these data were previously presented in April, today's session also showed that these positive findings for the DCB held true even for patients with diabetes, a population that typically presents with worse arterial disease and has poorer outcomes compared to non-diabetics.

November 3, 2014
The First Endovascular Abdominal Aortic Aneurysm Repair (EVAR)
Dr. Juan Parodi
Tomorrow begins the 14th Annual VIVA meeting in Las Vegas. The whole field of endovascular repair and intervention has grown exponentially since the first VIVA meetings. For example, the first endovascular repair of an abdominal aortic aneurysm was performed by Dr. Juan Parodi in 1990, but it took quite some time to be accepted as a standard of care. Today the endovascular approach is the preferred procedure to repair an AAA and this is because of the advances in medical devices and dedication of physicians to this less invasive non-surgical approach, physicians who will be attending this year's VIVA meeting.

November 3, 2014
CE Mark for New Medtronic Drug-Eluting Stent
Continuous Sinusoid Technology: entire stent is molded from a single strand of wire
The Resolute Onyx™, a new drug-eluting stent from Medtronic has received approval from the Conformité Européene and, according to the company, is now available in countries that recognize the CE Mark. This new stent builds on the success of the Resolute Integrity; what makes the Onyx different is that the wire itself consists of a dense inner core, wrapped in a cobalt alloy outer layer. Dubbed CoreWire Technology, this enhancement makes the stent more radiopaque (easier to see under fluoroscopy), and stronger, even though the struts are thinner.

October 29, 2014
Volcano Corporation Schedules Third Quarter Conference Call, Webcast
Volcano Corporation Headquarters
Volcano Corporation (Nasdaq: VOLC), a leading company focused on improving patient and economic outcomes on a global basis by developing and delivering innovative minimally invasive coronary and peripheral visualization, physiology diagnostics and therapies, today announced that it will report its operating results for the third quarter and first nine months of fiscal 2014 on Thursday, November 6. The company will hold a conference call to discuss its financial results and operating activities open to all interested parties at 2 p.m., Pacific Standard Time (5 p.m., Eastern Standard Time), Thursday, November 6.

October 20, 2014
Opsens Files To Become a New Player in the Fractional Flow Reserve Market
Opsens' OptoWire for FFR
Moving from the macro to the micro: that's the pathway taken by Quebec-based Opsens, Inc., known for its fiber optic pressure and temperature sensing technology in the oil fields. The company has miniaturized its technology and applied it to FFR wires that can be threaded into the coronary arteries to help determine whether or not a blockage needs to be opened with a stent. The company has filed with the FDA for 510(k) pre-market notification, recently achieved approval in Japan and is currently sponsoring the O2 Pilot Study.

October 20, 2014
Boston Scientific Begins Study of Drug-Eluting Stents in Women and Minorities
Dr. Wayne Batchelor
Today Boston Scientific enrolled its first patient in a new trial, dubbed PLATINUM Diversity trial, which will enroll up to 1,500 patients from these under-represented populations, specifically: Female, Black of African Heritage, Hispanic/Latino, American Indian or Alaska native. The trial will measure the performance of its drug-eluting stent, the Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System, in these groups. The principal investigators for the PLATINUM Diversity trial are Roxana Mehran, MD of Mount Sinai School of Medicine n New York, and Wayne Batchelor, MD of Tallahassee Memorial Hospital in Florida.

October 16, 2014
Fractional Flow Reserve and Ebola: Thresholds and Decision-Making
Thermometer and FFR Tracing
Commentary from the Editor's Blog: What do Ebola and Fractional Flow Reserve (FFR) have in common? Well, nothing, except that this week both events pointed to a lesson about the use of numbers, thresholds, guidelines and a physician's clinical judgement in making healthcare decisions.


October 14, 2014
Medtronic Announces FDA Approval of Pacing Lead for Full-Body MRI Scans
MRI scanner
Medtronic today announced the U.S. Food and Drug Administration (FDA) approval of its CapSureFix Novus™ MRI SureScan® 5076 Lead for use with magnetic resonance imaging (MRI). The lead is approved for MRI scans positioned on any region of the body when paired with a Medtronic dual-chamber MR-conditional pacemaker.


October 13, 2014
Positive 30-Day Results in Medtronic's CoreValve Direct Aortic Study
Medtronic's CoreValve
Today Medtronic (NYSE: MDT) announced the 30-day results from its CoreValve ADVANCE Direct Aortic (DA) Study at the 29th Annual Meeting of the European Association for Cardio-Thoracic Surgery (EACTS 2014) in Milan. The results were "exceptional," showing low rates of all-cause mortality, stroke (0% disabling stroke), and paravalvular leak.


October 12, 2014
FDA Approves Lutonix 035: First Drug-Coated Balloon for Blockages in Leg Arteries
Before and After the Lutonix Drug-Coated Balloon
The U.S. FDA has approved the first drug-coated balloon for use in opening up blockages in the peripheral arteries, specifically the superficial femoral or popliteal arteries in the leg. The Lutonix 035 was approved in Europe in 2012 but has taken an additional two years for the FDA to give it the go-ahead. An FDA panel unanimously recommended approval back in June, although there were questions regarding the results that showed no additional benefit in women above the therapy of a standard non-coated balloon.

October 8, 2014
ACIST Showcases Hi-Definition IVUS System
ACIST HDi™ High-Definition Intravascular Ultrasound System
At last month's Transcatheter Cardiovascular Therapeutics meeting in Washington, DC, a new high-definition intravascular ultrasound (IVUS) system was demonstrated as part of two live case broadcasts. The system, manufactured by ACIST Medical of Eden Prairie, Minnesota, is billed as "hi-def" because it images at a frequency of 60mHz. Current systems image in the range of 20mHz and 45mHz.

October 7, 2014
AimRADIAL Masterclass Comes to Chicago
Chicago Skyline
On October 23-25, 2014 the 3rd Advanced International Masterclass on the Transradial Approach will be held in Chicago and, if you already perform or want to start using the wrist approach to diagnostic or interventional procedures, you need to attend. Where else will you be able to spend two-and-a-half days with the most expert and experienced radial practitioners in the world?

October 6, 2014
Lisa Olson Takes the Reins at the Society for Cardiovascular Angiography and Interventions (SCAI)
Lisa Olson, PhD
Next week, Lisa Olson will be heading up administration at the Society for Cardiovascular Angiography and Interventions (SCAI) in Washington, DC. Her naming as the new Executive Director of the main professional organization that represents interventional cardiologists in the U.S. was announced last month. She succeeds longtime administrator Norm Linsky.


October 6, 2014
SCAI Updates Its Appropriate Use Criteria (AUC) Calculator Apps for Stent Procedures
Screenshots of SCAI app
The Society for Cardiovascular Angiography and Interventions (SCAI) has announced an expansion and update to its Appropriate Use Criteria calculator apps, now incorporating data for diagnostic catheterization and imaging. SCAI introduced this tool two years ago to aid interventional cardiologists in their decision-making process and to help document those decisions in the patient's record.

October 5, 2014
Will a Denial of Service DOS Attack Hit New York State Medicaid Patients? Or Perhaps Your State?
DOS Attack
What does a Denial of Service Attack have to do with stents, angioplasty and PCI? In the world of computing, a DOS attack is defined as "an attempt to make a machine or network resource unavailable to its intended users." Typically netbots programmed by hackers overwhelm the web servers of banks, credit card providers, etc. whose sites then become unavailable to their customers. Now it seems similarly that in New York State, cardiovascular treatments may become unavailable to some Medicaid patients: a denial of service.

October 3, 2014
FFR and iFR: Roadmapping Your Heart, With Traffic
Road map with traffic
What has become clearer in the past few years is that seeing is not believing. The angiogram may show a narrowing, but that narrowing may not be causing a reduced flow of blood to the heart, a.k.a. "ischemia." Stenting or bypassing such a "non-ischemic" narrowing may not be of much benefit to the patient, but it will add a small risk factor of stent restenosis or perhaps a surgical complication.

September 30, 2014
Infraredx Gains Approval in Japan for Its NIR/IVUS Coronary Imaging System
Infraredx TVC Image
Infraredx has announced that they have received approval in Japan for their TVC Imaging System, the only FDA-approved device to visualize and identify the large lipid core plaques that are thought to be most likely to cause a heart attack. Japan makes up 50% of the worldwide intravascular imaging market. The company, which has partnered with the Japanese firm Nipro, sees this approval as a significant milestone in their expansion strategy.

September 29, 2014
Glenn vs. The Volcano: Engaged Sends a Letter to Volcano Corporation
Volcano and Engaged Capital logos on illustration of coronary artery
(Updated September 30) Today saw a "volley across the bow" between Volcano Corporation (Nasdaq: VOLC), a major manufacturer of IVUS, FFR and iFR technologies, and Engaged Capital LLC, an investment firm which holds over two million shares, or 5.1%, of Volcano stock. Engaged founder Glenn W. Welling sent a letter to Volcano demanding that the company begin a search for a new CEO and find a buyer for the company. Volcano immediately issued a statement in response.

September 17, 2014
Medtronic Elects Elizabeth Nabel to the Board of Directors
Dr. Elizabeth Nabel
Medtronic, Inc. (NYSE: MDT) today announced that its Board of Directors elected Elizabeth Nabel, M.D. to the Board as an independent director. Dr. Nabel is a cardiologist and distinguished biomedical researcher and has served as president of Brigham & Women's hospital since 2010 where she has led the development of an innovative, comprehensive strategic plan that defines a new model of medicine.

September 16, 2014
Medtronic Drug-Coated Balloon Shows Strong Clinical and Economic Benefit in Treatment of Peripheral Artery Disease
IN.PACT drug-coated balloon
Presented at the 2014 Transcatheter Cardiovascular Therapeutics (TCT) conference, the latest clinical and economic data on the IN.PACT Admiral drug-coated balloon (DCB) from Medtronic, Inc. (NYSE: MDT) augments an already robust body of evidence that continues to drive a reconsideration of the standard of care for peripheral artery disease (PAD) in leg arteries above the knee. The results show that the IN.PACT Admiral DCB is not only clinically superior, but also cost-effective for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) or proximal popliteal artery (PPA) at 12 months compared to standard percutaneous transluminal angioplasty (PTA).

September 15, 2014
Medtronic Launches SEEQ™ Wearable Cardiac Monitoring System in United States
Medtronic's SEEQ™ Mobile Cardiac Telemetry (MCT) System
Medtronic, Inc. (NYSE: MDT) today announced the U.S. launch of the SEEQ™ Mobile Cardiac Telemetry (MCT) System, an external, wire-free, adhesive heart monitor that can be worn for up to 30 days to help detect and diagnose the cause of irregular heartbeats in patients. Medtronic completed the acquisition of U.S.-based Corventis, Inc., which developed the technology, in June 2014.

September 13, 2014
Medtronic CoreValve Data Demonstrate Favorable Cost Effectiveness Compared to Open-Heart Surgery in High Risk Patients
CoreValve with dollar signs
In the first-ever in-trial cost effectiveness analysis of transcatheter aortic valve replacement (TAVR) for patients at high risk for surgery, investigators today revealed new data demonstrating the cost effectiveness of the CoreValve® System from Medtronic, Inc. (NYSE: MDT) for high risk patients with severe aortic stenosis. The economic analysis used data from the CoreValve U.S. Pivotal Trial's study of high risk patients, which is the only head-to-head study to show the superiority of TAVR to traditional surgical aortic valve replacement (SAVR) at one year.

September 13, 2014
Medtronic CoreValve System Sustains Positive Outcomes Through Two Years in Extreme Risk Patients
CoreValve in heart
Medtronic, Inc. (NYSE: MDT) today announced new data showing that transcatheter aortic valve replacement (TAVR) with the CoreValve® System continued to provide safe and effective treatment, while maintaining exceptional rates of survival out to two years for patients who were considered too ill or frail to have their aortic valves replaced through traditional open-heart surgery. Without treatment, these patients had a 50 percent chance of death at one year.

September 11, 2014
FDA OKs Medtronic's Euphora Non-Compliant Coronary Balloon Catheter
Dr. Antonio Colombo
September 11, 2014 -- Coming just four months after its CE Mark European approval, the NC Euphora balloon has received the okay from the FDA for marketing in the United States. Non-compliant (NC) balloons are specifically designed to be used in post-stent dilatation, to ensure that the stent itself is fully expanded against the arterial wall. An under-expanded stent is associated with higher restenosis rates, as well as stent thrombosis, a phenomenon first described by Dr. Antonio Colombo in the early days of stenting.

September 11, 2014
Volcano Announces Activities at TCT 2014
Walter E. Washington Convention Center
The annual Transcatheter Cardiovascular Therapeutics meeting (TCT) starts this weekend in Washington, DC and runs through Wednesday, September 17. During that time many hundreds of presentations on the entire range of interventional procedures and devices will be offered to the 10,000 plus attendees. While the main focus usually has been on devices such as drug-eluting stents, balloons, and transcatheter aortic valve replacements (TAVR), an area that has become increasingly important in recent years is that of functional measurement.

September 10, 2014
Boston Scientific Announces Schedule For Presentations At Upcoming TCT 2014
Keith Dawkins, MD
Beginning Saturday, Boston Scientific Corporation (NYSE: BSX) will present data that reinforce the company's commitment to advancing science for life and to developing innovative therapies in interventional cardiology. The company will share results from more than a dozen clinical studies at the 26th Transcatheter Cardiovascular Therapeutics (TCT) meeting, the annual scientific symposium of the Cardiovascular Research Foundation, being held this year in Washington, D.C. from September 13-17.

September 10, 2014
Medtronic Begins U.S. Clinical Trial of Recapturable Transcatheter Aortic Valve
CoreValve in heart
Last week Medtronic, Inc. (NYSE: MDT) garnered the European CE Mark for its newest transcatheter aortic valve. Today the first U.S. patients received Medtronic's CoreValve Evolut R, launching a U.S. trial of 250 patients at 25 centers. This trial will look at safety and effectiveness of this device in patients at high or extreme risk for open-heart surgery.


September 3, 2014
Medtronic's Recapturable CoreValve Evolut R System Receives CE Mark
CoreValve Evolut R
Today Medtronic, Inc. (NYSE: MDT) reported that its next generation of the CoreValve transcatheter aortic valve has received the CE Mark and is now available in Europe and other countries that recognize the CE Mark. This new system offers greater accuracy, better fit, the ability to recapture and reposition the valve during deployment, and has the smallest sheath size (14F) curently availabe on the market.

September 2, 2014
Medtronic CFO Gary Ellis to Speak at Morgan Stanley Healthcare Conference
Medtronic logo

Medtronic, Inc. (NYSE: MDT), the world's leading medical technology company, today announced it will participate in the Morgan Stanley Global Healthcare Conference, September 8, 2014, in New York. Gary Ellis, executive vice president and chief financial officer of Medtronic, will make a presentation about Medtronic beginning at 3:25 p.m. EDT (2:25 p.m. CDT).

September 2, 2014
Two Year Data from FAME 2 Trial Shows Sustained Benefits of FFR-Guided PCI over Medical Treatment in Patients with Stable CAD
Dr. Bernard De Bruyne
St. Jude Medical, Inc. (NYSE: STJ), a global medical device company, today announced primary outcome two-year data from the FAME 2 Trial which demonstrated sustained superiority with FFR-guided PCI using St. Jude Medical PressureWire™ technology in patients with stable coronary artery disease (CAD) compared to standard medical therapy alone.

September 2, 2014
Volcano Corporation Presentation At Morgan Stanley Conference To Be Webcast
Grand Hyatt NYC
Volcano Corporation (Nasdaq: VOLC) said today that it will be participating in the Morgan Stanley Healthcare conference on Tuesday, September 9. The presentation by Scott Huennekens, president and chief executive officer, will begin at 11:10 a.m., Eastern Daylight Time (8:10 a.m., Pacific Daylight Time).

September 1, 2014
Frontiers in Interventional Cardiology Symposium
picture of faculty
If you're an interventional cardiologist, Fellow, or in the allied health fields, and you aren't able to make it to Washington for the five-day-long TCT meeting, you can get a quick dose of the latest and greatest in a single day on Saturday, September 20, in Short Hills, New Jersey. Titled "Frontiers in Interventional Cardiology," this symposium is presented by the Morristown Medical Center, part of the Atlantic Health System, and features a stellar international faculty, including Maurice Buchbinder, George Dangas, Eberhard Grube, Raoul Bonan, and Stephen Ellis.

August 12, 2014
Access to Abbott's MitraClip® System Expands in the U.S. with Medicare National Coverage Determination
MitraClip from Abbott Vascular
The Centers for Medicare & Medicaid Services (CMS) recently issued a National Coverage Determination (NCD) that extends coverage for Medicare beneficiaries in the United States to Transcatheter Mitral Valve Repair with Abbott's (NYSE: ABT) MitraClip® System. The MitraClip System is a first-of-its-kind device that provides new hope for people with severe degenerative mitral regurgitation who are not good candidates for surgery. Treatment with MitraClip can significantly improve symptoms and quality of life by reducing the backward flow of blood through the mitral valve in the heart.

August 7, 2014
Volcano Reports Second Quarter Results
Volcano Corporation logo
Volcano Corporation (Nasdaq: VOLC) today reported results for the second quarter and first six months of 2014. The company also announced today that it will be seeking a divestiture of its Axsun Technologies, Inc. subsidiary. In addition, the company said that it and St. Jude Medical, Inc., (NYSE: STJ) have agreed to settle all existing litigation between the two companies.

August 5, 2014
Volcano Corporation Presentation At Canaccord Genuity Conference To Be Webcast
Boston Skyline
Volcano Corporation (Nasdaq: VOLC) said today that it will be participating in the Canaccord Genuity Growth Conference on Wednesday, August 13. The presentation by Scott Huennekens, president and chief executive officer, will begin at 1:30 p.m., Eastern Daylight Time (10:30 a.m., Pacific Daylight Time).


August 4, 2014
Medtronic Enters the FFR and IVUS Technology Field With ACIST Co-Promotion Agreement
ACIST Navvus FFR Catheter
Today Medtronic, Inc. (NYSE: MDT) and ACIST Medical Systems, Inc., a Bracco Group company, announced a strategic agreement to bring ACIST's FFR and IVUS products into U.S. cath labs. This collaboration marks the first time a major stent manufacturer will offer both FFR and IVUS technologies.


August 1, 2014
Volcano Corporation Announces Webcast Of Analyst Day
New York Hilton Midtown
Volcano Corporation (Nasdaq: VOLC) will hold its 2014 Analyst Day on Monday, August 11, at the New York Hilton Midtown in New York City. A webcast of the event will begin at 8:30 a.m., Eastern Daylight Time (5:30 a.m., Pacific Daylight Time) and conclude at approximately 12 p.m., Eastern Daylight Time (9 a.m., Pacific Daylight Time).


July 28, 2014
Volcano Corporation Schedules Second Quarter Conference Call, Webcast
Volcano Headquarters
San Diego, CA
Volcano Corporation (Nasdaq: VOLC) today announced that it will report its operating results for the first quarter and first six months of fiscal 2014 on Thursday, August 7. The company will hold a conference call to discuss its financial results and operating activities open to all interested parties at 2 p.m., Pacific Daylight Time (5 p.m., Eastern Daylight Time), Thursday, August 7, hosted by Scott Huennekens, president and chief executive officer, and John Dahldorf, chief financial officer.

July 26, 2014
Boston Scientific Gets FDA Approval for REBEL Bare Metal Stent
Boston Scientific's REBEL bare metal stent
Take away the everolimus-eluting polymer from Boston Scientific's FDA-approved Promus PREMIER™ stent and what do you have? The REBEL bare metal stent, which just received FDA approval. The announcement of this new bare metal stent may seem anticlimactic, except that there is still a market for non-drug-coated stents. There are instances when, for one reason or another, patients are not ideal candidates for drug-eluting stents.

July 22, 2014
Boston Scientific Launches POLARIS™ Imaging System
Boston Scientific's POLARIS™ Imaging System
Boston Scientific Corporation (NYSE: BSX) has initiated full commercial launch of the new POLARIS™ Imaging System. This system will support the Boston Scientific family of intravascular ultrasound (IVUS) catheters, including coronary, peripheral and intra-cardiac echo products. The POLARIS System offers enhanced ease-of-use and more powerful processing capabilities. Its modular design would also support the planned release of new Boston Scientific imaging products including a fractional flow reserve (FFR) wire, a new family of IVUS catheters, enhanced software features and better system control tools.

July 14, 2014
Boston Scientific Receives CE Mark For The New 25mm Lotus™ Valve System
Boston Scientific's Lotus Transcatheter Aortic Valve
Boston Scientific Corporation (NYSE: BSX) has received CE Mark and begun the European commercial launch of its new 25mm Lotus™ Transcatheter Aortic Valve Implantation (TAVI) System, complementing the currently available 23mm and 27mm valve sizes. Prior to full commercialization, a limited market evaluation of the 25mm valve Lotus Valve System was performed in select hospitals across Europe and Australia. Feedback on the valve performance was favorable from all implanting physicians.

June 25, 2014
Study Published in The New England Journal of Medicine Finds Medtronic Insertable Cardiac Monitors Detect Atrial Fibrillation in Stroke Patients Better Than Standard Care
Medtronic's Reveal XT Insertable Cardiac Monitor
Medtronic, Inc. (NYSE: MDT), today announced results from the CRYSTAL AF (CRYptogenic STroke And underLying Atrial Fibrillation) Clinical Trial have been published in The New England Journal of Medicine. The Trial found that continuous cardiac monitoring with the Reveal® XT Insertable Cardiac Monitor (ICM) was superior to standard care at detecting atrial fibrillation (AF) in patients who have had strokes of undetermined causes (cryptogenic stroke).

June 19, 2014
Medtronic Announces Preliminary Outcomes for World's Smallest Cardiac Pacemaker
Micra pacemaker in heart
Medtronic, Inc. (NYSE: MDT) today announced preliminary results from the first human implants of the world's smallest pacemaker, the Micra™ Transcatheter Pacing System (TPS). Results from the first four patients to receive the Micra TPS were reported at CARDIOSTIM / EHRA EUROPACE 2014, World Congress in Electrophysiology and Cardiac Techniques, in Nice, France. At 1 month and 3 months, results showed the Micra TPS was successfully implanted in all patients, whose ages ranged from 74 to 83 years, and there were no major complications post-implant. The device performed as expected, and electrical values were within normal ranges.

June 16, 2014
Edwards Lifesciences Launching Sapien XT Valve In The U.S.
Edwards Sapien XT Animation
Edwards Lifesciences Corporation (NYSE: EW) today announced that it has received United States Food and Drug Administration (FDA) approval for its Edwards SAPIEN XT transcatheter aortic heart valve for the treatment of high-risk and inoperable patients suffering from severe symptomatic aortic stenosis (AS). This next-generation, lower-profile system, which includes the 29mm valve size for patients with a large native annulus, will allow for the treatment of more patients.

June 12, 2014
Medtronic CoreValve System Receives FDA Approval for Patients at High Risk for Surgery
CoreValve in situ
Medtronic, Inc. (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) approval of the self-expanding transcatheter CoreValve® System for patients with severe aortic stenosis who are at high risk for surgery.This approval is based on groundbreaking research that showed clinical outcomes at one year with the CoreValve System were superior to open-heart surgery, the current gold standard for aortic valve replacement. The FDA approved the CoreValve System without the need for an independent device advisory panel review due to its exceptionally positive clinical results demonstrated in the High Risk Study of the CoreValve U.S. Pivotal Trial.

June 11, 2014
Medtronic Submits Final Data to FDA for Novel Device to Treat Peripheral Artery Disease
IN.PACT Admiral drug-coated balloon
Medtronic, Inc. (NYSE: MDT) today announced that it recently submitted the final module of its pre-market approval (PMA) application for the IN.PACT Admiral drug-coated balloon to the U.S. Food and Drug Administration (FDA). The application includes data that demonstrates superior clinical outcomes compared with conventional angioplasty, with the lowest rates of repeat procedures (target lesion revascularization) and the highest rate of uninterrupted blood flow (primary patency) at 12 months ever reported for the interventional treatment of peripheral artery disease.

June 4, 2014
Medtronic Expands Availability of Market-Leading Aortic & Peripheral Solutions to U.S. Market
Valiant Captivia
Medtronic, Inc. (NYSE: MDT) announced today that two recently Food and Drug Administration (FDA) approved devices will be featured at the Society for Vascular Surgery's 2014 Vascular Annual Meeting, taking place June 5-7 in Boston. Valiant Captivia Thoracic Stent Graft system proximal FreeFlo tapers line extension now with dissection indication, and the TOTAL across crossing support catheter for peripheral artery disease (PAD) in the below-the-knee (BTK) vessel bed are now available to physicians in the United States.

June 3, 2014
Volcano Corporation Schedules Conference Call, Webcast To Discuss iFR® Technology Market Opportunity
iFR diagram
Volcano Corporation (Nasdaq: VOLC) said today that it will be holding a conference call and webcast to discuss the market expansion opportunity for its iFR (instant wave-Free Ratio™) technology on Thursday, June 5. The presentation by John Dahldorf, chief financial officer, and Joseph Burnett, executive vice president, coronary and systems business unit, will begin at 1:30 p.m., Pacific Daylight Time (4:30 Eastern Daylight Time).

Jun 2, 2014
Volcano Corporation Presentation At Goldman Sachs Healthcare Conference To Be Webcast
Rancho Palos Verdes, CA
Volcano Corporation (Nasdaq: VOLC), a platform company providing and guiding minimally invasive therapies utilizing visualization, physiology or future technologies, said today that it will be participating in the Goldman Sachs 35th Annual Global Healthcare Conference on Tuesday, June 10. The presentation by John Dahldorf, chief financial officer, will begin at 11:20 a.m., Pacific Daylight Time (2:20 p.m., Eastern Daylight Time)

May 27, 2014
Volcano Corporation Announces Agreement To Acquire AtheroMed
AtheroMed's Phoenix Atherectomy System
Volcano Corporation (Nasdaq: VOLC) said today it has signed an agreement to acquire AtheroMed, Inc., a privately-held company that has developed the Phoenix® Atherectomy System used in the treatment of peripheral artery disease (PAD). The Phoenix, which received 510(k) clearance in January 2014 and has a CE Mark, enables physicians to treat PAD with a low profile peripheral atherectomy catheter that continuously removes diseased material as it is debulked. The device has reimbursement in the U.S. and select countries in Europe.

May 21, 2014
Medtronic CoreValve® System Demonstrates Positive Clinical Performance at Two Years in 'Real World' ADVANCE Study
Medtronic's CoreValve
Medtronic, Inc. (NYSE: MDT) today revealed new data showing that patients treated with the CoreValve® System experienced positive clinical outcomes in the rigorous "real world" Medtronic CoreValve ADVANCE Study. Two-year follow-up was reported on 96.8 percent of 1,015 patients, all of whom had severe aortic stenosis and were treated with the CoreValve System. Patients experienced low rates of all-cause mortality (25.6 percent), cardiovascular mortality (16.8 percent) and major stroke (2.9 percent) at two years.

May 20, 2014
Medtronic Announces CE Mark and Launch of NC Euphora™ Coronary Balloon
Continuing its commitment to bringing advanced and clinically relevant interventional technologies to market, Medtronic, Inc. (NYSE: MDT) today announced CE (Conformité Européene) mark and launch of the NC Euphora™ Noncompliant Balloon Dilatation Catheter. The NC Euphora Balloon Catheter is now available in Europe and other countries outside of the United States that recognize the CE mark. It is not yet available in the United States.

May 20, 2014
Medtronic Reports Fourth Quarter and Fiscal Year 2014 Earnings
Medtronic logo
Medtronic, Inc. (NYSE: MDT) today announced financial results for its fourth quarter and fiscal year 2014, which ended April 25, 2014. The company reported worldwide fourth quarter revenue of $4.566 billion, compared to the $4.459 billion reported in the fourth quarter of fiscal year 2013, an increase of 3 percent on a constant currency basis after adjusting for a $39 million negative foreign currency impact or 2 percent as reported.

May 20, 2014
Medtronic Settles Global Patent Litigation with Edwards Lifesciences
Medtronic and Edwards logos
Medtronic, Inc. (NYSE: MDT) announced that it has reached a global patent settlement agreement with Edwards Lifesciences Corporation (NYSE:EW). Under the terms of the cross-license settlement agreement, the parties will dismiss all of the pending litigation matters and patent office actions between them, and grant each other broad releases to patent litigation claims. Medtronic will pay Edwards a one-time payment of $750 million, and ongoing royalty payments through April 2022 based on a percentage of CoreValve sales, in payments of no less than $40 million annually.

May 13, 2014
SCAI and CRF Training Programs in Transradial PCI
Diagram of Radial Artery
The next few months offer some unique training opportunities for the U.S. interventional cardiologist regarding the transradial approach to catheterization, angioplasty and stent implantation via the wrist artery.



May 5, 2014
Volcano Corporation Presentation At Bank Of America Merrill Lynch 2014 Health Care Conference To Be Webcast
Encore at Wynn Resort, Las Vegas
Volcano Corporation (Nasdaq: VOLC) said today that it will be participating in the Bank of America Merrill Lynch 2014 Health Care Conference on Tuesday, May 13. The presentation by John Dahldorf, chief financial officer, will begin at 4:20 p.m., Pacific Daylight Time (7:20 p.m., Eastern Daylight Time).


May 4, 2014
Abbott's MitraClip Approved in Canada
MitraClip from Abbott Vascular
Abbott (NYSE: ABT) has announced that its MitraClip Delivery System has been approved in Canada for use in patients "with degenerative mitral regurgitation who are too high risk for mitral valve surgery based on evaluation by a team of heart doctors, including a heart surgeon." The ruling by Health Canada now allows sale of the MitraClip throughout the country; the MitraClip was approved by the FDA for use in the United States last October.

May 2, 2014
Volcano Reports First Quarter Results
Volcano Corporation Headquarters in San Diego
Volcano Corporation (Nasdaq: VOLC) today reported results for the first quarter of 2014. For the quarter ended March 31, 2014, Volcano reported revenues of $94.5 million versus revenues of $93.2 million in the same period a year ago. On a constant currency basis, revenues increased four percent year-over-year after adjusting for a negative impact of approximately $2.7 million from foreign currency.

April 29, 2014
Medtronic Reveals Positive Outcomes for CoreValve® Patients Treated via Alternative Access Routes
Medtronic's CoreValve
Medtronic, Inc. (NYSE: MDT) today revealed new data demonstrating positive outcomes for extreme risk patients with severe aortic stenosis who were treated with the CoreValve® System via alternative access approaches. The study evaluated 150 patients from the CoreValve U.S. Pivotal Trial (23 percent of the extreme risk patient group) who were not suitable for traditional transcatheter aortic valve replacement (TAVR) through the femoral artery, and therefore were treated via subclavian or direct aortic approaches.

April 25, 2014
Volcano Announces Limited Market Release of SyncVision™ Technology System
Volcano Logo
Volcano Corporation (NASDAQ: VOLC) today announced the commencement of its limited market release of its FDA cleared and CE marked technology SyncVision™, with cases being performed in the U.S. and Europe. SyncVision™ is currently installed in multiple limited market release sites throughout U.S. and Europe. Volcano's SyncVision™ Technology System is an on-line image processing workstation for coronary catheterizations that allows the physician to navigate simultaneously on an angiogram and on an IVUS image in a single correlated view using co-registration of the Eagle Eye® Platinum catheter with x-ray angiography.

April 21, 2014
Edwards Lifesciences Comments on U.S. Appeals Court Order
Edwards and Medtronic logos
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced that the U.S. Court of Appeals for the Federal Circuit today issued a stay for the preliminary injunction that was ordered on April 11 to limit the sale of Medtronic's CoreValve system in the United States. Today's order postpones the implementation of the preliminary injunction. It does not reverse the federal jury's finding of Medtronic's willful infringement, for which all appeals have been exhausted, and does not affect the determination of additional damages.

April 21, 2014
Federal Appeals Court Agrees to Medtronic Request to Postpone Injunction
Medtronic's CoreValve
The Federal Circuit Court of Appeals today granted a request from Medtronic, Inc. (NYSE: MDT) to postpone the implementation of an injunction that would have prevented the company from selling its CoreValve® System in the United States. This means the injunction will only take effect if the appellate court determines the injunction was properly issued. In addition, last week the Court of Appeals agreed to an expedited appeal of the injunction ruling, with the last appeal brief to be submitted by June 19.

April 19, 2014
Update on CoreValve Federal District Court Ruling; Court Agrees to Expedited Appeal
CoreValve and Gavel
Medtronic, Inc. (NYSE: MDT) today issued an updated statement on the recent ruling by Federal District Court of Delaware. Medtronic has asked the U.S. Circuit Court of Appeals to postpone the injunction until it can determine if the injunction was properly issued. The Court has not yet ruled. Medtronic also requested, and the Court agreed to, an expedited appeal of the injunction ruling, and other underlying legal issues, with the last appeal brief to be submitted by June 19. Medtronic does not believe Edwards Lifesciences, which brought the motion for a preliminary injunction, has met the standards needed for an injunction, particularly with respect to the impact it will have on the public health interest.

April 18, 2014
Endurant AAA Stent Graft from Medtronic Continues Exceptional Long-Term Performance in Observational Studies
Endurant AAA stent graft
The Endurant AAA stent graft system from Medtronic, Inc. (NYSE: MDT) continues to demonstrate exceptional long-term performance in the endovascular treatment of abdominal aortic aneurysms, according to new clinical data from two separate observational studies -- PANDORA, independently conducted at two sites in Germany; and ENGAGE, sponsored by Medtronic and involving 79 sites worldwide.

April 17, 2014
MARS Across the Hudson: Mid-Atlantic Radial Symposium is May 3
Dr. Jordan Safirstein and his Google Glass
If you are an interventional cardiologist or work in a cath lab where the transradial approach is being utilized, and you live anywhere near New York-New Jersey-Pennsylvania, you might want to consider a day trip to Morristown, New Jersey on May 3. This trip won't cost you anything, because the Mid-Atlantic Radial Symposium (MARS) is free; and yes, there still is such a thing as a free lunch.

April 17, 2014
Volcano Corporation Schedules First Quarter Conference Call, Webcast
Scott Huennekens, President & CEO, Volcano Corporation
Volcano Corporation (Nasdaq:VOLC) announced that it will report its operating results for the first quarter of fiscal 2014 on Friday, May 2. The company will hold a conference call to discuss its financial results and operating activities open to all interested parties at 2 pm, Pacific Daylight Time (5 pm, Eastern Daylight Time), Friday, May 2, hosted by Scott Huennekens, president and chief executive officer, and John Dahldorf, chief financial officer.

April 14, 2014
Valve Wars, Part III: Edwards vs. Medtronic
Medtronic and Edwards logos
Another volley across the bow in the ongoing heart valve wars was served up Friday, when the U.S. District Court for the District of Delaware granted Edwards Lifesciences (NYSE: EW), the manufacturer of the Sapien transcatheter aortic valve, a preliminary injunction that will limit Medtronic's (NYSE: NDT) sales of its competing CoreValve system in the United States. Barring further rulings, the injunction will go into effect on April 22.

April 11, 2014
FDA Approves Start of Trial for Cobra PzF™ Stent
close-up of COBRA PzF stent surface
A clinical trial for a novel concept coronary stent will soon start enrolling patients in the United States: the COBRA PzF™ coronary stent system was given an investigative device exemption (IDE) by the FDA last month and will shortly begin recruiting at 14 U.S. hospitals; 13 outside U.S. sites have already started the process.


April 10, 2014
Abbott's Absorb Bioresorbable Scaffold Completes Enrollment in 3 Pivotal Clinical Trials
Abbott Absorb Bioresorbable Scaffold
Today, Abbott announced that it has completed enrollment of not one, but three pivotal clinical trials to support approval of the Absorb BVS in the United States, Japan, and China, three countries that comprise 50% of the global market for stents. The trials pit the Absorb Bioresorbable Vascular Scaffold against Abbott's flagship everolimus-eluting XIENCE stent in almost 3,000 patients worldwide.

April 5, 2014
'IN.PACT Admiral' Drug-Coated Balloon From Medtronic Outperforms Standard Angioplasty In Landmark Study
IN.PACT Admiral Drug-Eluting Balloon
Patients with peripheral artery disease in the upper leg experienced significantly better outcomes at 12 months after treatment with the IN.PACT Admiral drug-coated balloon from Medtronic, Inc. (NYSE: MDT) than with standard balloon angioplasty, according to a landmark clinical study reported on today for the first time. The IN.PACT SFA Trial enrolled 331 subjects at 57 sites across Europe and the United States.

March 31, 2014
ZEUS: Drug-Eluting Stent Outperforms Bare Metal for Safety and Efficacy in At-Risk Patients
Drug Eluting Stents vs. Bare Metal Stents
According to research presented at the American College of Cardiology's 63rd Annual Scientific Session, the use of Medtronic's Endeavor zotarolimus-eluting stent is associated with a lower risk of major cardiovascular events at one year compared to bare metal stents among a patient population normally excluded from treatment with drug-eluting stents. The positive finding in ZEUS for patients receiving a shorter than currently recommended course of blood thinners may call into question existing guidelines for a more prolonged antiplatelet therapy following placement of drug-eluting stents.

March 31, 2014
Medtronic CoreValve® System Demonstrates Long-Term Durability
Medtronic's CoreValve
The Study results showed the long-term durability and excellent clinical performance of the CoreValve System with no incidences of structural valve dysfunction at four years. The study also showed significant improvements in quality of life at one year which were sustained through four years, with 74 percent of patients improving at least one New York Heart Association (NYHA) functional class from baseline to four years. Additionally, the rates of regurgitation and stroke remained low, with 83.0 percent of patients free from stroke at four years follow-up.

March 30, 2014
World's First Transcatheter Valve, Medtronic Melody® Transcatheter Pulmonary Valve Shows Positive Clinical Outcomes in Real-World Study
Melody® Transcatheter Pulmonary Valve
The Melody® Transcatheter Pulmonary Valve (TPV) U.S. Post-Approval Study found that real-world use of the Melody TPV was associated with high procedural success, excellent valve function and few repeat procedures at the primary endpoint of six months. These results were sustained out to one year. The Melody TPV was the first transcatheter valve to be approved by the U.S. Food and Drug Administration (FDA) and the first transcatheter valve available anywhere in the world. The therapy has treated more than 6,000 patients worldwide to date, more than half of whom are children with congenital heart disease (CHD).

March 30, 2014
Robot Stent Placement in the Cath Lab
Robotics in the Cath Lab
Angioplasty and stent placement is the gold standard for the emergency treatment of heart attacks. But getting the patient to a catheterization lab where the angioplasty can be performed in a timely fashion has been a challenge. Now, Corindus Vascular Robotics is testing a new solution, whereby an interventional cardiologist may be able to perform an angioplasty and precisely place a stent -- from another city!

March 30, 2014
Medtronic Global SYMPLICITY Registry Shows Strong Safety Profile of the Symplicity™ Renal Denervation System
Renal sympathetic nerves and the kidney
Medtronic, Inc. (NYSE: MDT), announced today further analysis of six-month follow-up data from the first 1,000 patients enrolled in the Global SYMPLICITY Registry, which continue to demonstrate the safety of the Symplicity™ renal denervation system. The results of this observational, open-label study show that renal denervation with the Symplicity™ renal denervation system resulted in significant reductions in both office and 24-hour ambulatory blood pressure compared to baseline, with very low adverse event rates to six months.

March 29, 2014
Boston Scientific LOTUS™ Valve System Demonstrates Sustained Safety and Efficacy Outcomes at Three Months
Professor Ian Meredith
The REPRISE II clinical trial, evaluating the Lotus™ Valve System in symptomatic patients with severe aortic valve stenosis and considered at high risk for surgical valve replacement, demonstrated favorable safety and efficacy outcomes out to three months with 85 percent of patients having no paravalvular aortic regurgitation (leaking). The data were presented by Professor Ian Meredith, director of MonashHeart at Monash Medical Centre in Melbourne, Australia, and principal investigator of the REPRISE II trial.

March 29, 2014
Medtronic CoreValve® System Results Superior to Open-Heart Surgery at One Year in U.S. Pivotal Trial
Medtronic's CoreValve
Medtronic, Inc. (NYSE: MDT) today announced that the CoreValve® System showed results superior to surgical aortic valve replacement (SAVR) at one year in the High Risk Study of its CoreValve U.S. Pivotal Trial, which evaluated patients with severe aortic stenosis who are considered high risk for surgery. The data were presented at a late-breaking clinical trial session at the 63rd Annual Scientific Session of the American College of Cardiology (ACC) and simultaneously published in The New England Journal of Medicine.

March 29, 2014
Medtronic Releases Results of SYMPLICITY HTN-3
Medtronic's Symplicity Renal Denervation System
Medtronic, Inc. (NYSE: MDT) today announced the full results of the SYMPLICITY HTN-3 clinical trial, which were presented today at the 63rd Scientific Sessions of the American College of Cardiology (ACC) and published simultaneously in The New England Journal of Medicine. SYMPLICITY HTN-3, the first and only blinded, randomized, sham controlled study of renal denervation for treatment-resistant hypertension, met its primary safety endpoint but did not meet its primary or secondary efficacy endpoints.

March 19, 2014
FDA Approves Volcano's iFR® Pressure Measurement Modality for Use in Coronary Stent Guidance
Volcano's iFR system measures intracoronary pressures without need for adenosine
This morning Volcano Corporation announced that the U.S. Food and Drug Administration has granted approval to the company's proprietary coronary pressure measurement modality, iFR (Instant wave-Free Ratio). iFR represents a significant advance in the field of functional measurement (FM), in which the actual flow pressures inside the coronary artery can be measured and the deficit caused by a coronary blockage or lesion can be accurately assessed.

March 17, 2014
Boston Scientific Gets European Approval for the REBEL: a "New" Bare Metal Stent
Boston Scientific's REBEL bare metal stent
Take away the everolimus-eluting polymer from Boston Scientific's FDA-approved Promus PREMIER™ stent and what do you have? The REBEL bare metal stent, which just received CE Mark approval last week and is now available for the European market. REBEL is probably a good name for this device, in that it "rebels" against the historical norm, wherein a bare metal stent platform first gets approved for safety and efficacy, and only then gets coated with a drug-eluting polymer, is tested in clinical trials, gets CE Mark approval and finally FDA approval.

March 10, 2014
Medtronic Seeking Long-Distance Runners Who Benefit From Medical Technology

Medtronic Global Heroes
Medtronic, Inc. (NYSE: MDT) announced today applications are open to runners around the world who benefit from medical technology to represent their country on the 2014 Medtronic Global Heroes team. The 2014 Medtronic Twin Cities Marathon weekend will take place October 3-5, 2014.


March 6, 2014
Valve Wars, Part II: Edwards vs. Medtronic
Medtronic's CoreValve
Last summer the District Court of Mannheim issued an injunction prohibiting Medtronic from selling its CoreValve and CoreValve Evolut transcatheter valves in Germany. The injunction was based on the Spenser patent. Today Medtronic announced that the European Patent Office has revoked the Spenser patent in its entirety. This outcome is a big win for Medtronic in Europe, although the ruling is subject to appeal by Edwards.

March 3, 2014
Volcano Corporation Presentation At Barclays Conference To Be Webcast
Volcano Headquarters
Volcano Corporation (Nasdaq: VOLC) said today that it will be participating in the Barclays Global Healthcare Conference 2014 on Tuesday, March 11. The presentation by John Dahldorf, chief financial officer, will begin at 11:15 a.m., Eastern Daylight Time (8:15 a.m., Pacific Daylight Time).

February 27, 2014
Can Near-Infrared Imaging Predict Heart Attack Risk?
Infraredx TVC Imaging System
What causes a heart attack? Is it a physical narrowing in the coronary artery, a blockage that can be seen on angiography? Or is it more likely the eruption of a lipid-rich plaque, a so-called vulnerable plaque, that may not look significant in percent stenosis during a standard catheterization? Today MedStar Heart Institute and Infraredx announced enrollment of the first patient in the Lipid-Rich Plaque (LRP) Study, which will involve 100 centers worldwide and has a target enrollment of 9,000 patients. As Infraredx founder Dr. James Muller states, "Once completed, the LRP Study could redefine the role of intravascular imaging and lay the groundwork for changing standard protocol for managing coronary artery disease."

February 26, 2014
Spring Training: Transradial Style
Baseball and U.S. map
No less than four U.S. training courses in Transradial Angioplasty have just been announced for this Spring (and, yes, Spring is actually going to come after this very long winter). And all of these training opportunities are being offered at no cost. The courses span the length and breadth of the United States. From East to West.


February 24, 2014
The Incredible Shrinking Cardiac Devices
Micra pacemaker in heart
The "world's smallest, minimally invasive cardiac pacemaker," Medtronic's Micra™ Transcatheter Pacing System, was implanted last week for the first time in the United States. This implantation comes just two-plus months after its first in-human implantation, performed in Austria. Both implantations are part of a single-arm multi-center clinical trial which will enroll up to 780 patients.

February 24, 2014
RENLANE™ Renal Denervation System from Cordis Gets CE Mark
Darrel Francis, MD
Even while panels and journals continue to debate the efficacy of renal denervation in treating resistent hypertension, a situation brought to the forefront by Medtronic's announcement in January that its pivotal U.S. renal denervation trial failed to meet its pre-specified endpoint, the Conformité Européenne has bestowed its CE Mark on a brand new system from Cordis Corporation.

February 24, 2014
Volcano Reports Fourth Quarter Revenues Increase Six Percent On A Constant Currency Basis
Volcano logo
Volcano Corporation (Nasdaq: VOLC) today reported results for the fourth quarter and all of 2013. For the quarter ended December 31, 2013, Volcano reported revenues of $103.3 million versus revenues of $102.5 million in the same period a year ago. On a constant currency basis, revenues increased six percent year-over-year after adjusting for a negative impact of approximately $5.5 million from foreign currency. The company reported a net loss on a GAAP basis of $20.5 million, or $0.38 per share, in the fourth quarter of 2013, versus net income of $2.5 million, or $0.04 per diluted share, in the same period a year ago.

February 20, 2014
Angioplasty Arrives in the Outback: First Stent Placed in Northern Territory
Australia - Northern Territory
It's been over 35 years since the first angioplasty was performed in Zurich by Dr. Andreas Gruentzig, but it was just yesterday that this minimally invasive procedure arrived in Australia's Northern Territory. As reported today by Sky News, Dr. Marcus Ilton, chief cardiologist at Royal Darwin Hospital, performed the first angioplasty and stent implantation ever done in the NT.

February 19, 2014
Medtronic Announces Global Launch of Miniature Cardiac Monitor, Reveal LINQ™ ICM
Medtronic's Reveal LINQ ICM compared to Reveal XT
Medtronic, Inc. (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) 510(k) clearance, CE (Conformité Européenne) Mark, and the global launch of its Reveal LINQ Insertable Cardiac Monitor (ICM) System, the smallest implantable cardiac monitoring device available for patients. The Reveal LINQ ICM is approximately one-third the size of a AAA battery (~1 cc), making it more than 80 percent smaller than other ICMs.

February 18, 2014
Medtronic Reports Third Quarter Earnings
Medtronic Headquarters
Medtronic, Inc. (NYSE: MDT) today announced financial results for its third quarter of fiscal year 2014, which ended January 24, 2014. The company reported worldwide third quarter revenue of $4.163 billion, compared to the $4.027 billion reported in the third quarter of fiscal year 2013, an increase of 4 percent on a constant currency basis after adjusting for a $41 million negative foreign currency impact or 3 percent as reported.

February 13, 2014
Medtronic Launches New Peripheral Angioplasty Catheter in Europe
Medtronic's TOTAL across crossing catheter
Today Medtronic, Inc. (NYSE: MDT) announced the European launch of its latest product to address the problems of peripheral artery disease (PAD), the "TOTAL Across" crossing catheter, intended for use in the lower extremities, specifically those arterial blockages below the knee that often are the cause of critical limb ischemia. Today's announcement by Medtronic adds to their portfolio of peripheral devices, including the IN.PACT drug-eluting balloon, and several balloon catheters designed for use in challenging narrow below-the-knee blockages.

February 11, 2014
DUTCH PEERS: Third Generation Drug-Eluting Stents from Medtronic and Boston Scientific Are (Almost) Equivalent
Resolute Integrity vs. Promus Element
Are third generation drug-eluting stents interchangeable? And what exactly is a "third generation" drug-eluting stent anyway? These were questions addressed by the DUTCH PEERS randomized clinical trial, recently published in The Lancet. The results showed that the Resolute Integrity was non-inferior to the Promus Element. There was, however, one parameter in which the two stents were not the same: longitudinal stent deformation.

February 11, 2014
Medtronic to Announce Financial Results for Its Third Quarter of Fiscal Year 2014
Medtronic, Inc.
Medtronic, Inc. (NYSE: MDT) announced today it will report financial results for the third quarter of its fiscal year 2014 on Tuesday, February 18, 2014. Medtronic will host a webcast at 7:00 a.m. CST to discuss financial results for its third quarter. The webcast can be accessed by clicking on the Investors link through the Medtronic website at www.medtronic.com on February 18, 2014.

February 9, 2014
Capsule-Sized Leadless Pacemakers May Lead the Way in Heart Rhythm Management
St. Jude's Nanostim leadless pacemaker
Is the future of implantable pacemakers a miniaturized leadless capsule, no bigger than a coin, delivered non-surgically via a catheter, much like a stent during angioplasty? Looking at the recent news from two of the leading manufacturers of pacemakers, one would conclude in the affirmative. Last week, St. Jude Medical announced the first U.S. implantation of their leadless Nanostim pacemaker (press release below) at Mt. Sinai Hospital in New York. The next-in-line challenger to St. Jude is Medtronic, who announced the first human implant of its leadless Micra catheter in December.

February 5, 2014
CVS To Stop Selling Cigarettes and Tobacco at a Cost of $2 Billion Annually
CVS Logo - CVS quits for good
CVS/pharmacy made an extraordinary announcement today: the company has decided to stop selling cigarettes and all tobacco products by October 1 of this year. As stated by Larry Merlo, President and CEO of CVS, "Tobacco products have no place in a setting where health care is delivered."


February 5, 2014
Boston Scientific Launches OffRoad™ Re-Entry Catheter System
Boston Scientific's OffRoad Re-Entry Catheter System
The OffRoad Re-Entry Catheter System is intended to help physicians navigate around complete arterial blockages by traveling within the tissue of the vessel wall (subintimal space). Once the catheter has passed the blockage, a unique conical-shaped positioning balloon is used to expand the subintimal space and direct a micro-catheter lancet to re-enter the vessel. This allows the physician to position a guidewire across the occlusion and to then treat the blockage using traditional endovascular techniques such as angioplasty and stenting.

February 4, 2014
Volcano Corporation Schedules Fourth Quarter Conference Call, Webcast
Volcano Headquarters
Volcano Corporation (NASDAQ: VOLC) today announced that it will report its operating results for the fourth quarter of fiscal 2013 on Monday, February 24. The company will hold a conference call to discuss its financial results and operating activities open to all interested parties at 2 p.m., Pacific Standard Time (5 p.m., Eastern Standard Time), Monday, February 24, hosted by Scott Huennekens, president and chief executive officer, and John Dahldorf, chief financial officer.

January 31, 2014
Ask George W. Bush a Question About His Stent…or Anything Else
Ask Bush a Question
Six months ago, former President Bush received an angioplasty and stent. The stent was recommended by Bush's doctors to open a blockage in one of his coronary arteries, found during his annual physical exam. The next week saw numerous articles in the mainstream media and professional publications questioning whether this stent was necessary. So…at this year's CRT 2014 meeting, held annually in Washington, D.C., Dr. Ron Waksman and the rest of the organizers have arranged for George W. Bush to be a featured speaker. And they have been emailing all potential attendees with the subject line, "Submit a Question for President Bush!"

January 28, 2014
Medtronic Relocates Its Regional Headquarters to Dubai
Dubai marina
Medtronic, Inc. (NYSE: MDT), the world's largest medical technology company, providing therapies to treat many conditions including cardiac and vascular diseases, diabetes, neurological and spinal conditions, today announced the relocation of its regional Middle East and Africa (MEA) headquarters to Dubai. The company will relocate all its regional operations to TECOM Investment's DuBiotech. DuBiotech is a freezone dedicated to facilitating and fostering growth of the life sciences industry in the United Arab Emirates (UAE).

January 28, 2014
FDA Approves Medtronic's Valiant Captivia Stent Graft for Treatment of Aortic Dissections
Valiant Captivia tip
Currently type B aortic dissections are managed in three ways: emergency open surgical repair, medical management, and endovascular repair. Today, the FDA approved a new indication for an endovascular device, the Valiant Captivia Thoracic Stent Graft System, made by Medtronic, based on the positive results of the DISSECTION Trial. The trial met its primary safety endpoint by achieving an 8% all-cause mortality rate at 30 days, which represents, according to the company's press release, a three-to-four-fold mortality improvement over open surgical repair.

January 27, 2014
$3.4 Million Grant to Saint Luke's Mid America Heart Institute for Chronic Total Occlusion PCI Study
Chronic total occlusions (CTO) historically have been one of the most difficult and challenging areas for minimally invasive treatment with angioplasty and stents. This $3.4 million grant being given to Saint Luke's Mid America Heart Institute by Boston Scientific will aid in helping to "better define the success, safety, health benefits, and cost-effectiveness of novel methods to open challenging blocked coronary arteries previously thought untreatable through minimally invasive techniques."

January 23, 2014
Boston Scientific Names Dr. Craig Thompson Chief Medical Officer for Interventional Cardiology
Craig Thompson, MD
Boston Scientific started off its New Year by naming Craig A. Thompson, MD, MMSc, as the new Chief Medical Officer for Interventional Cardiology. Dr. Thompson is well-known to the field, having served as Director of the Cardiovascular Catheterization Laboratory at the Dartmouth-Hitchcock Medical Center and most recently Director, Invasive Cardiology and Vascular Medicine at Yale New Haven Hospital. Dr. Thompson has presented regularly at professional symposia and specifically on two topics that we at Angioplasty.Org have been covering for some time: intravascular ultrasound (IVUS) and the transradial approach to diagnostic and interventional procedures.

January 17, 2014
FDA Approves Medtronic's CoreValve; Device Available Immediately in U.S.
Medtronic's CoreValve
This morning the U.S. Food and Drug Administration approved Medtronic's self-expanding transcatheter CoreValve® system for patients who are too sick to withstand traditional aortic valve replacement open heart surgery. Although an approval had been expected during the first half of this year, today's announcement took the cardiology community by surprise. The CoreValve sytem is now the second transcatheter aortic valve device available in the U.S., breaking the monopoly currently enjoyed by the Edwards Sapien valve for high risk patients. A Medtronic spokesperson confirmed to Angioplasty.Org that the CoreValve is available as of today for use in the United States.

January 16, 2014
50 Years Ago Today Charles Dotter Invented Angioplasty
Charles Dotter, MD
It was 50 years ago today that Dr. Charles T. Dotter, a radiologist in Portland, Oregon, performed the first angioplasty. But it wasn't in the heart; it was in the leg. An 82-year-old woman was suffering from great pain in her left foot because of blocked circulation in her leg. Her toes had become gangrenous and there was an non-healing ulcer. Amputation was recommended by the physicians at Oregon Health Sciences University, but the woman refused. A video clip from my documentary "Explorers of the Heart" tells more.

January 15, 2014
Edwards and Medtronic: "Valve Wars"
Medtronic and Edwards logos
A decade ago it was "stent wars"; now it's "valve wars." Percutaneous transcatheter aortic valve replacements to be exact: also called TAVR or TAVI. With these new devices, an aortic valve replacement (or implantation) can be accomplished using catheter-based techniques similar to coronary angioplasty, and without the need for open surgery. And when the competition is fierce, the patent suits appear: today a federal jury handed a victory to Edwards, finding "willful infringement" by Medtronic of Edwards' Cribier patent, and awarding $394 million in damages. Medtronic immediately announced that it would appeal the verdict.

January 13, 2014
Another Viewpoint on Renal Denervation and SYMPLICITY HTN-3 from Dr. Darrel Francis
Dr. Darrel Francis
Is the failure of the SYMPLICITY HTN-3 trial to meet its efficacy endpoint the "end of the road" for renal denervation? Will renal denervation now land on the heap of failed technologies? I don't think so, and Dr. Darrel Francis, the cardiologist who famously predicted that SYMPLICITY HTN-3 would not meet its endpoint, agrees. In fact Dr. Francis told Angioplasty.Org that it would be a "grave error" if the FDA withheld renal denervation from the American people, based on this news! OK. Do I have your attention?

January 13, 2014
Volcano Corporation Announces Preliminary Fourth Quarter 2013 Revenues; Year-Over-Year Annual Revenues Increase Eight Percent On A Constant Currency Basis
Volcano logo
Volcano Corporation (Nasdaq: VOLC) said today that it expects total revenues on a reported basis for the fourth quarter of 2013 will be approximately $103.3 million, bringing expected full year 2013 revenues on a reported basis to approximately $393.7 million—in line with most recent guidance. Revenues for the fourth quarter of 2013 reflect an increase of one percent and six percent on a reported basis and constant currency basis, respectively, compared to the fourth quarter a year ago.

January 9, 2014
Medtronic's U.S. Renal Denervation Trial Fails to Meet Efficacy Endpoint
Renal sympathetic nerves and the kidney
In a definite blow to the entire field of renal denervation, Medtronic reported this morning that its pivotal U.S. clinical trial for the Symplicity™ Renal Denervation System has failed to meet its endpoint for efficacy. Pending review by a panel of invited experts, the company has suspended enrollment in all of its renal denervation clinical studies worldwide. Dr. Rick Kuntz, chief medical officer for Medtronic, stated: "We believe this course of action is the most prudent and will help us thoroughly evaluate these findings and determine the appropriate next steps for renal denervation therapy."

January 6, 2014
Volcano Corporation Presentation At J.P. Morgan Conference To Be Webcast
Volcano HQ in San Diego
Volcano Corporation (Nasdaq: VOLC) said today that it will be participating in the 32nd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15. The presentation by Scott Huennekens, president and chief executive officer, will begin at 3:30 p.m., Pacific Standard Time (6:30 p.m., Eastern Standard Time).

Click here for more information about the following ads