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November 15, 2015
COURAGE: Does 15-Year Data Have Any Clinical Relevance?
stent and pills
This past week saw publication of an update to the 2007 COURAGE trial which compared optimal medical therapy (OMT) to stenting (PCI) as the initial management strategy for stable coronary artery disease. The study looked at 15-year data and concluded that there was no advantage to PCI. I beg to differ.

October 14, 2015
Medtronic Drug-Coated Balloon Sustains Superiority Over Balloon Angioplasty at Two Years in Patients with Peripheral Arterial Disease
IN.PACT® Admiral® drug-coated balloon (DCB)
Medtronic plc (NYSE: MDT) announced today that new two-year clinical data from the pivotal IN.PACT SFA Trial revealed that the IN.PACT® Admiral® drug-coated balloon (DCB) continues to provide superior clinical outcomes at two years compared to standard balloon angioplasty for the interventional treatment of peripheral arterial disease (PAD) in the upper leg - specifically, in the thigh (superficial femoral arteries or SFA) and behind the knee (popliteal arteries).

October 13, 2015
Scripps Cardiologists Eric Topol & Paul Teirstein To Do Book Signing at TCT on Oct. 14
photo of textbook
Noted Scripps Clinic cardiologists Eric Topol, M.D., and Paul Teirstein, M.D., will sign copies of their newly released 7th Edition of “Textbook of Interventional Cardiology,” an indispensable resource for clinicians who need a guide to interventional procedures. The signing will take place during the 27th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium at the Scripps Health Exhibition Booth #2524 in Moscone Center, South Hall, San Francisco, Wednesday, October 14, from 12:45pm - 1:45 pm.

October 13, 2015
Medtronic's Drug-Filled Stent: First Data
Medtronic's Drug-Filled Stent
Called a DFS ("drug-filled stent") it is both a drug-eluting stent AND a bare metal stent, utilizing the same 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 laser-drilled holes in the metal outer core.

September 7, 2015
AimRADIAL Masterclass IV in Liverpool
Liverpool at night
Next week, on September 17-18, 2015, the 4th Advanced International Masterclass on the Transradial Approach will be held in Liverpool, England 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-days with the most expert and experienced radial practitioners in the world?

September 3, 2015
Frontiers in Cardiology – One Day Course in New Jersey
photos of faculty for Frontiers in Cardiology course
If you're a cardiologist, Fellow, or in the allied health fields, and you weren't able to make it to London for the five-day-long European Congress of Cardiology meeting, you can get a quick dose of the latest and greatest in a single day on Saturday, September 19, in Short Hills, New Jersey. Titled "Frontiers in 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, Roxana Mehran, James Udelson, Nanette Wenger, and more.

September 3, 2015
FDA Approves Expanded Indication for AstraZeneca Medications to Include Long-Term Use in Patients with a History of Heart Attack
Brilinta packages
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved BRILINTA® (ticagrelor) tablets at a new 60mg dose to be used in patients with a history of heart attack beyond the first year. With this expanded indication, BRILINTA is now approved to reduce the rate of cardiovascular death, myocardial infarction (MI, also known as heart attack) and stroke in patients with acute coronary syndrome (ACS) or a history of MI.

August 31, 2015
Medtronic Study Detects Gene Associated with Sudden Cardiac Death
photo of Dr. Sumeet Chugh
Medtronic plc (NYSE: MDT) today announced first-of-its-kind findings from two independent studies that have identified a gene associated with life-threatening abnormal heart rhythms. The study results were presented in a hotline session at the 2015 European Society of Cardiology (ESC) Congress in London. The studies evaluated genetic "markers" to determine which gene abnormalities may be associated with dangerous heart rhythms that can lead to sudden cardiac death (SCD).

August 31, 2015
Medtronic Acquires Medina Medical
Medtronic logo
Medtronic plc (NYSE:MDT) today announced it has acquired Medina Medical, a Menlo Park, Calif.-based and privately-held medical device company focused on commercializing state-of-the-art treatments for vascular abnormalities of the brain including cerebral aneurysms. This acquisition is another example of the company's commitment to its key growth strategy of therapy innovation.

August 29, 2015
Radial Revolution in the U.S.
Seton Medical Center
Commentary from the Editor's Blog: This approach was pioneered by Dr. Ferdinand Kiemeneij in 1992. Since then, advances in the technique and in the equipment, along with the dedication of these pioneering physicians, has brought the radial approach to the forefront, resulting in today's paradigm-changing announcement. And I use the term"paradigm-changing" knowingly. It's overused, to the point of being a joke to be sure. But in this case, it is totally valid!!

August 29, 2015
European Guidelines Say "Radial First"
transradial access
Today the European Society of Cardiology (ESC) gave the highest recommendation to the radial (wrist) approach for catheter-based interventions in patients with acute coronary syndromes (ACS). The "ACS without persistent ST-segment elevation (NSTE-ACS) guidelines," drafted by an international multidisciplinary Task Force, were introduced as part of this year's annual European Congress of Cardiology meeting, and are now published online.

August 25, 2015
"A Type of Interventional Radiology": A Quaint Memory from the New York Times
NY Times magazine from 1983
I recently was rifling through some old files of news clippings (you remember those pesky things, don't you?) and came across a major New York Times Magazine feature from 1983. It was titled, "Toward the Conquest of Heart Disease." Near the end of the article, the author briefly mentions something he calls "a type of interventional radiology" which has "great potential advantages but remains experimental."

August 25, 2015
Medtronic Moves into Mitral Valve Replacement
This morning, Medtronic plc (NYSE: MDT) announced it has agreed to acquire privately-held device company Twelve, Inc., based in Redwood City, California. Twelve has been developing a transcatheter mitral valve replacement device (TMVR) which is just beginning its first clinical pilot study, "Evaluation of Safety and Performance of the Twelve Transcatheter Mitral Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation." Medtronic has agreed to pay up to $458 million for Twelve including $408 million at closing and $50 million on achievement of CE Marking.

August 19, 2015
WomenHeart To Host First National Policy & Science Summit On Women's Cardiovascular Health
Women forming heart
WomenHeart: The National Coalition for Women with Heart Disease today announced that it will host the first National Policy & Science Summit on Women's Cardiovascular Health, October 26-27, 2015 in Washington, DC. "The Summit is a game changer for the field of women's cardiovascular health," said Mary E. McGowan, CEO of WomenHeart. "Leaders in this field and patients are meeting to address the lack of sufficient policy, programs and funding for a disease that continues to debilitate and kill more women than all cancers combined."

August 11, 2015
Mount Sinai Launches TWILIGHT: Is Ticagrelor Alone Superior to DAPT Post-PCI?
Dr. Roxana Mehran and Dr. Annapoorna Kini in cath lab
Today Mount Sinai Medical Center in New York announced the launch of a new and very large randomized clinical trial to test the safety and efficacy of ticagrelor alone versus ticagrelor and aspirin together in high risk PCI patients. The international study, called TWILIGHT, aims to enroll 9,000 patients at 100 sites in the U.S., Canada, Europe, South America, and Asia. The study is being funded by AstraZeneca, the manufacturer of the blood-thinner ticagrelor (brand name Brilinta).

August 5, 2015
Medtronic Launches the Entrust™ Delivery System in the United States
Dr. George Meier
Medtronic plc (NYSE: MDT) today announced the launch of its Entrust™ delivery system in the United States. The new Entrust delivery system enables physicians to place Medtronic's EverFlex™ self-expanding peripheral stent, while maintaining a low profile and providing the ease of a one-handed device.

June 23, 2015
FDA Approves New Repositionable and Recapturable CoreValve from Medtronic
CoreValve® Evolut™ R
Today the FDA approved Medtronic's (NYSE: MDT) next-generation CoreValve Evolut R System for severe aortic stenosis patients who are at high or extreme risk for surgery. The Evolut R is the first and only recapturable and repositionable TAVR system available in the United States. In addition, the Evolut R system is offers a 14F delivery system, the narrowest profile currently available, and may reduce the type of vascular access complications that can occur with these larger devices.

June 10, 2015
Medtronic Initiates U.S. Launch of Fortrex™ PTA Balloon
Dr. Brian L. Dunfee
Medtronic plc (NYSE: MDT) announced today the launch of the Fortrex™ over-the-wire (OTW) percutaneous transluminal angioplasty (PTA) balloon catheter. The Fortrex PTA balloon catheter utilizes a high pressure balloon to break up the blockages and open the vessels to help maintain arteriovenous (AV) access in the peripheral vascular system.

June 3, 2015
FDA OK for St. Jude to Resume Portico TAVR Trial
St. Jude's Portico Transcatheter Aortic Valve
Today St. Jude Medical announced FDA approval to resume their U.S. IDE trial for the Portico Transcatheter Aortic Valve System. The trial had been put on pause back in September 2014 due to safety concerns. According to St. Jude's press release (below) both a company and independent review of the data have concluded that this reduced leaflet mobility is "a class effect," seen in all TAVR devices, as well as surgical valves.

May 20, 2015
Medtronic Drug-Coated Balloon for Treatment of Peripheral Arterial Disease Shows Strong Results in Long Lesions
Prof. Dierk Scheinert
Presented for the first time today at EuroPCR during the "Hot line" session on "Peripheral interventions," new clinical data from two different studies show that the IN.PACT Admiral drug-coated balloon from Medtronic plc (NYSE: MDT) successfully treated long lesions in the superficial femoral and popliteal arteries. Prof. Dierk Scheinert, chairman of the division for interventional angiology at University-Hospital Leipzig in Germany, presented 12-month results for 157 patients enrolled in the IN.PACT Global Study's long lesion imaging cohort.

May 20, 2015
Ferdinand Kiemeneij and Shigeru Saito Honored at EuroPCR for Contributions to Transradial PCI
Drs. Ferdinand Kiemeneij and Shigeru Saito
This year's EuroPCR meeting, the world-leading course in interventional medicine, honored two pioneers of the transradial (wrist) approach for coronary catheterization and intervention (TRI): Dr. Ferdinand Kiemeneij from The Netherlands and Dr. Shigeru Saito from Japan. Both have received the 2015 Ethica Award, bestowed by the PCR Board and EuroPCR Course Directors to remarkable individuals who have significantly contributed to the field of cardiovascular intervention as teachers, innovators, scientists, care providers, or pioneers.

May 15, 2015
Global Clinical Trial Finds Medtronic Micra® Transcatheter Pacemaker Meets Initial Safety and Performance Measures
Micra pacemaker in heart (compared to Euro coin, upper right)
Medtronic plc (NYSE: MDT) today announced study results of its Micra® Transcatheter Pacing System (TPS), which demonstrated that the miniaturized pacemaker has met its initial safety and performance measures. In the largest report to date of a transcatheter pacing system, 100 percent of the first 140 patients who received the Micra TPS experienced a successful implant procedure, and mean electrical pacing measurements at all patient visits (one- and three--month follow up) were within expected ranges.

May 14, 2015
Global Trial Finds Medtronic Micra® Transcatheter Pacemaker Meets Initial Safety Measures in Wide Range of Patients
Dr. L.V.A. Boersma
Medtronic plc (NYSE: MDT) revealed today the first safety data on its Micra® Transcatheter Pacing System (TPS). In the largest reported sample of a transcatheter pacing system to date, the first 140 patients in the Medtronic Micra TPS Global Clinical Trial showed 100 percent were successfully implanted with the Micra TPS. The data were presented at Heart Rhythm 2015, the Heart Rhythm Society's 36th Annual Scientific Sessions in Boston.

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
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).

April 9, 2015
Medtronic Initiates U.S. Launch of HawkOne™ Directional Atherectomy System for Treatment of Peripheral Arterial Disease
Medtronic plc (NYSE: MDT) enhances its leading directional atherectomy portfolio with the U.S. launch of the HawkOne™ directional atherectomy system. The HawkOne system provides physicians with a solution to treat all plaque morphologies in patients with peripheral arterial disease, including patients who have plaque blockages that have become severely calcified.

April 1, 2015
EverFlex™ Peripheral Stent from Medtronic Delivers Sustained Patency in Long, Complex Lesions
The EverFlex™ self-expanding peripheral stent system from Medtronic plc (NYSE: MDT) has proven to provide sustained patency in the treatment of long, complex lesions in the superficial femoral (SFA) and popliteal arteries, according to the three-year results of the DURABILITY II study, which are reported in the recent issue of Catheterization and Cardiovascular Intervention.

April 1, 2015
Medtronic Announces New SPYRAL HTN Global Clinical Trial Program for Renal Denervation
Symplicity Spyral™ Multi-electrode Renal Denervation Catheter
Medtronic plc (NYSE:MDT) today announced the initiation of the SPYRAL HTN Global Clinical Trial Program, a unique, phased clinical program studying renal denervation in uncontrolled hypertension. This announcement follows investigational device exemption (IDE) approval by the U.S. Food and Drug Administration (FDA). The program will begin with two global studies designed to address the confounding factors encountered in the SYMPLICITY HTN-3 clinical trial, including medication, patient population and procedural variability, to ensure the clinical potential of the therapy is evaluated.

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 16, 2015
MATRIX: Wrist is Safer Access Point than Groin for Catheter-Based Heart Procedures
Dr. Marco Valgimigli
Patients with acute coronary syndrome undergoing coronary angiogram, a procedure used to assess blockages in the heart's arteries, had a significantly lower risk of major bleeding and death if their interventional cardiologist accessed the heart through an artery in the wrist rather than the groin, according to research presented at the American College of Cardiology's 64th Annual Scientific Session. Study authors said the results should prompt a re-evaluation of clinical guidelines and that the wrist, currently used in a minority of cases in the United States, should be the preferred approach for most catheter-based heart procedures.

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, 2015
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, 2015
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.

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