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 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 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.

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
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).


December 17, 2013

Medtronic Randomizes First Patients in SYMPLICITY HTN-4, the First U.S. Renal Denervation Clinical Study for Patients with Moderate Uncontrolled Hypertension
Symplicity renal denervation system
Medtronic, Inc. (NYSE: MDT), announced today that the first patients were randomized in SYMPLICITY HTN-4, evaluating the Symplicity™ renal denervation system in patients with moderate uncontrolled hypertension (systolic blood pressure greater than or equal to 140 and less than 160 mm Hg, despite treatment with three or more anti-hypertensive medications of different classes).

December 12, 2013
St. Jude Medical Gains CE Mark for 25 mm Portico Transcatheter Aortic Heart Valve
St. Jude's Portico Transcatheter Aortic Valve
St. Jude Medical, Inc. (NYSE:STJ) has received European CE Mark approval for its 25 mm Portico™ Transcatheter Aortic Heart Valve Implantation System. The approval expands the number of patients who can be treated using the Portico heart valve during transcatheter aortic valve replacement (TAVR) procedures. TAVR is an option for patients with symptomatic severe aortic stenosis (a narrowing of the aortic heart valve that obstructs blood flow from the heart). These patients are considered high-risk for conventional open-heart valve replacement surgery.

December 12, 2013
St. Jude Cancels EnligHTN IV U.S. Renal Denervation Trial Due to "Anticipated Recruitment Challenges"
EnligHTN™ Renal Denervation System
Mounting a multicenter, randomized, blinded, controlled clinical trial is an expensive proposition. So when device manufacturer St. Jude Medical, Inc. (NYSE:STJ) decided last week to stop its EnligHTN IV Renal Denervation Study, the first U.S. trial using the EnligHTN™ Multi-Electrode Renal Denervation System to treat patients with drug-resistant high blood pressure, there had to be a good reason. And there was.

December 9, 2013
Medtronic Announces First Human Implant of World's Smallest, Minimally Invasive Cardiac Pacemaker
Micra pacemaker in heart (compared to Euro coin, upper right)
Medtronic, Inc. (NYSE: MDT), today announced the first-in-human implant of the world's smallest pacemaker: the Micra™ Transcatheter Pacing System (TPS). The device was implanted in a patient in Linz, Austria as part of the Medtronic global pivotal clinical trial. The Micra TPS is an investigational device worldwide. At one-tenth the size of a conventional pacemaker, and comparable in size to a large vitamin, the Micra TPS is delivered directly into the heart through a catheter inserted in the femoral vein.

December 6, 2013
New Medtronic Multi-Electrode Renal Denervation Device Gets CE Mark and Australian Approval
Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter
Medtronic (NYSE: MDT) has announced that its multi-electrode Symplicity Spyral™ catheter and Symplicity G3™ radio frequency (RF) generator for patients with treatment-resistant hypertension has received both the CE Mark (Conformité Européenne) in Europe and Therapeutic Goods Administration (TGA) listing in Australia.


December 2, 2013
Volcano Corporation Announces $200 Million Share Repurchase Authorization
Scott Huennekens
Volcano Corporation (NASDAQ: VOLC) today announced that its Board of Directors has authorized a $200 million share repurchase program. The Company intends to fund share repurchases with cash on hand. As part of the program, Volcano will enter into a $100 million Accelerated Share Repurchase ("ASR") with J.P. Morgan Securities LLC ("JPMorgan"), as agent for JPMorgan Chase Bank, National Association, London Branch. Under the ASR agreement, Volcano will pay $100 million to JPMorgan and will receive from JPMorgan an initial delivery of 3,557,137 shares of Volcano's common stock.

November 25, 2013
Endurant II AAA Stent Graft from Medtronic Delivers Durable, Consistent and Proven Outcomes in Real-World Setting
Endurant II AAA Stent Graft
Chosen for nearly one out of every two endovascular abdominal aortic aneurysm (AAA) repairs worldwide, the Endurant II AAA stent graft system from Medtronic, Inc. (NYSE: MDT) continues to demonstrate long-term durability and consistent outcomes at three years in a real-world setting. The latest data on the market-leading stent graft were presented on Friday at the VEITHsymposium in New York City.

November 25, 2013
Boston Scientific Receives FDA Approval For Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System
Promus PREMIER Everolimus-Eluting Stent
Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval for the Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System, the company's next-generation durable polymer drug-eluting stent (DES). The technology is available immediately in the U.S., with the first implantation scheduled to be performed by Martin Leon, M.D., director, Center for Interventional Vascular Therapy at Columbia University Medical Center / New York-Presbyterian Hospital, New York City.

November 20, 2013
Valiant 'Mona LSA' Stent Graft System from Medtronic Demonstrates Proof of Concept in Early Feasibility Study
Medtronic's Valiant® Mona LSA System Thoracic Stent Graft System
The first device of its kind to undergo clinical evaluation in the United States, the Valiant "Mona LSA" branch thoracic stent graft system from Medtronic, Inc. (NYSE: MDT) has demonstrated proof of concept in a first-in-human study being conducted under the U.S. Food and Drug Administration (FDA)'s "Innovation Pathway" early feasibility pilot program, according to data presented today at the 2013 VEITHsymposium.

November 14, 2013
Medtronic to Resume Sales of CoreValve System in Germany
Medtronic's CoreValve
Medtronic, Inc. (NYSE: MDT) announced that a German court today ordered the discontinuation, in its entirety, of a prior court ruling that prohibited Medtronic from commercially marketing or selling the CoreValve® System in Germany since August 26, 2013. The Higher Regional Court Karlsruhe explained that, due to the European Patent Office (EPO) preliminary opinion that the Edwards' EP2055266 Spenser patent claims are not valid, it could not assume "with sufficient likelihood" that the Spenser patent is valid.

November 13, 2013
Volcano Corporation Announces First Commercial Implantations of Crux® Vena Cava Filter
Dr. Thomas Fogarty
Volcano Corporation (NASDAQ: VOLC) today announced the commercial release and initial implantations of its innovative Crux® Vena Cava Filter (VCF) in patients at risk for recurrent pulmonary embolism (PE). It is the only filter with a double helical design that self-centers to help prevent filter tilt and offers the Bi-Trieval™ option of retrieval via either the jugular or femoral vein.

November 13, 2013
Best Uses from SCAI for Intravascular Ultrasound, Fractional Flow Reserve and Optical Coherence Tomography Tools
OCT, IVUS and FFR
This morning the Society for Cardiovascular Angiography and Interventions (SCAI) issued a guidance document for the use of three major intra-coronary diagnostic tools for use in stenting and angioplasty. Published in the society's journal, Catheterization and Cardiovascular Interventions, the document details the best use of intravascular Ultrasound (IVUS), Fractional Flow Reserve (FFR) and Optical Coherence Tomography (OCT) as they relate to the diagnosis and optimal placements of stents.

November 7, 2013
Medtronic's CoreValve: Very Positive One-Year Results from Pivotal U.S. Trial
Medtronic's CoreValve
The one-year results from Medtronic's (NYSE: MDT) pivotal U.S. trial for the CoreValve transcatheter aortic valve replacement (TAVR) device were presented recently at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco, and the results in the extremely risky patient cohort were so clearly favorable that the FDA has waived the requirement for the usual expert panel discussion.

November 7, 2013
30 Days Results of Boston Scientific's Lotus TAVR Valve Presented at TCT
Lotus Valve System
At the recent Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco, Boston Scientific's entry into the transaortic valve replacement (TAVR) field was highlighted in a First Report Investigation report of the REPRISE II Trial, studying the Lotus Valve. Dr. Ian Meredith of the Monash Medical Centre in Melbourne, Australia, presented the 30-day results of 120 patients who received this unique repositionable valve.

November 5, 2013
FDA Approves Medtronic Renal Denervation Study for Moderate Uncontrolled Hypertension
Symplicity renal denervation system
Medtronic, Inc. (NYSE: MDT) has announced enrollment of its first patient in a new U.S. clinical trial of renal denervation, this one targeted to test the efficacy of this technology in patients with moderate uncontrolled hypertension. The SYMPLICTY HTN-4 clinical trial will be the first randomized, controlled clinical trial ever to investigate renal denervation in patients with moderate uncontrolled hypertension; it is the second renal denervation trial that Medtronic has launched in the United States.

November 4, 2013
iFR Can Reduce Use of Adenosine, Saving Time and Costs in Assessing Need for Stents
iFR Graphic
When Fractional Flow Reserve (FFR) has been used as a decision-making tool in the DEFER, FAME and FAME II studies, the use of stenting declined by one-third, saving costs for the healthcare system and significantly improving outcomes for patients. One drawback to FFR, however, is that a vasodilator, such as adenosine, must be given to the patient to measure the blood flow accurately: this increases costs and often causes discomfort for the patient. In the past few years, however, a new measurement has been developed by researchers in London and is being commercialized by Volcano Corporation (NASDAQ: VOLC). Called iFR (Instantaneous wave-Free Ratio) a functional measurement of ischemia in an artery can be performed very quickly and without need for a vasodilating agent.

November 4, 2013
For Stent Procedures Intravascular Ultrasound (IVUS) Improves Outcomes and Reduces Complications: ADAPT-DES
IVUS Image
Two-year results from the largest study to date of intravascular ultrasound (IVUS) use during angioplasty and stent placement were presented at the 25th Annual Transcatheter Cardiovascular Therapeutics meeting in San Francisco last week, and the numbers were pretty clear: IVUS use showed 53% less stent thrombosis, 38% lower rate of myocardial infarction (heart attack) and 34% less incidence of major adverse cardiac events (MACE).

November 4, 2013
Volcano Reports Third Quarter Results
Scott Huennekens, President and CEO, Volcano Corp
Volcano Corporation (Nasdaq: VOLC), a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today reported results for the third quarter and first nine months of 2013. The company also today announced a strategic reprioritization and reallocation of resources within its distribution, research and development and clinical programs to focus on areas of strong projected growth in FFR (Fractional Flow Reserve), peripheral applications, coronary IVUS (Intravascular Imaging) driven by the ADAPT-DES clinical data and Axsun Medical.

November 2, 2013
Surgery, Stents and Sports: "Let's Go to the Videotape!"
Video control room in an early angioplasty live demonstration course
Commentary from the Editor's Blog: A recent New York Times article delves into a topic not often discussed: the fact that some surgeons are more skilled than others. "A Vital Measure: Your Surgeon's Skill" by Dr. Pauline W. Chen is a fascinating look at a taboo topic. Dr. Chen describes an innovative program where a group of expert surgeons judges how skilled a particular colleague is by looking at a close-up videotape of how he or she works with their hands, utilizes equipment, and so on. However, watching procedures on video is nothing new to me, or to any member of the interventional cardiology community.

October 31, 2013
In Trial of Rivals, Medtronic's Resolute Integrity Stent Outperforms Promus Element Stent on Longitudinal Strength
Resolute Integrity vs. Promus Element
In the first head-to-head randomized controlled trial of "third-generation" durable-polymer drug-eluting stents for the treatment of coronary artery disease in an "all-comers" patient population, the Resolute Integrity drug-eluting stent (DES) from Medtronic, Inc. (NYSE: MDT) and the Promus Element DES from Boston Scientific Corp. performed similarly on all measures except longitudinal strength, which favored the Medtronic device.

October 31, 2013
Andreas Gruentzig: In His Own Words
Andreas R. Gruentzig, MD
Commentary from the Editor's Blog: On Tuesday morning the Transcatheter Cardiovascular Therapeutics (TCT) 2013 Conference celebrated the "father of angioplasty," Dr. Andreas Roland Gruentzig, with the Career Achievement Award. Gruentzig, who died in 1985, was honored with a very moving tribute, which included a video, remembrances from his colleagues, and by the presence of his wife and two daughters, who were flown in from Zurich and Berlin by the TCT to receive the award on his behalf.

October 31, 2013
In Studies of Medtronic Stents, Patients Who Interrupted Dual Antiplatelet Therapy Early Saw No Increased Thrombosis Risk
Stent and pills
According to findings from several studies presented at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, patients with coronary artery disease who received an Endeavor or Resolute drug-eluting stent from Medtronic, Inc. (NYSE: MDT) and subsequently interrupted their dual antiplatelet therapy (DAPT) earlier than current guidelines recommend experienced no increased risk of stent thrombosis at one year or more of follow up. Both devices elute the drug zotarolimus to reduce the risk of restenosis.

October 30, 2013
Medtronic CoreValve U.S. Pivotal Trial Affirms Benefits of Self-Expanding Transcatheter Aortic Valve Replacement in Patients Treated Via Alternative Access Routes
Medtronic's CoreValve
Following the first U.S. data presented on the Medtronic CoreValve® System in patients treated via the transfemoral approach, Medtronic, Inc. (NYSE: MDT) today announced the positive results of patients treated via alternative access routes as part of the same Extreme Risk Study within the CoreValve U.S. Pivotal Trial. Presented at Transcatheter Cardiovascular Therapeutics (TCT) Conference, the first-of-its-kind observational analysis found that the novel self-expanding valve provided life-saving and quality of life benefits to patients treated via the subclavian and direct aortic ("non-iliofemoral") access routes despite the higher risk nature of the patient population.

October 30, 2013
Medtronic Presents Three-Year Results From SYMPLICITY HTN-2 Showing Significant and Sustained Drops in Blood Pressure After Treatment with the Symplicity™ Renal Denervation System
Symplicity Renal Denervation System
Medtronic, Inc. (NYSE: MDT) presented three-year data from SYMPLICITY HTN-2, the first and longest-running randomized, controlled clinical trial of renal denervation, which continue to demonstrate results consistent with data reported previously at six, 12 and 24-months of follow-up. The data were presented for the first time during an oral abstract session on Tuesday, October 29, 2013 at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) Symposium taking place this week in San Francisco.

October 27, 2013
Volcano Announces Upcoming Data Presentations from Large-Scale Studies on Physiology and Imaging Technologies at TCT 2013
iFR graphic
Volcano Corporation (NASDAQ: VOLC) today announced several significant clinical data presentations and other activities related to its physiology and Intravascular Ultrasound (IVUS) technologies at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, being held in San Francisco from October 27 to November 1. The data include final results from the ADVISE II (ADenosine Vasodilator Independent Stenosis Evaluation) Registry, which will be presented in a Late-Breaking Clinical Trials session on October 30.

October 27, 2013
SCAI Issues Best Practices for Transradial Angiography and Angioplasty from the Wrist
Graph of transradial use in U.S.
This week the Society for Cardiovascular Angiography and Interventions (SCAI) issued an important "best practices" document, addressing the transradial approach in which diagnostic angiography and stents are guided to the coronary arteries via the radial artery in the wrist. The transradial approach, although used far more frequently in Europe, Japan and India, has increased 13-fold in the U.S. over the past five years. The SCAI document covers a wide range of topics: for example, how to transition a hospital to the radial approach, how to avoid blocked blood flow in the radial artery (radial artery occlusion or RAO), and how to reduce radiation exposure.

October 25, 2013
Abbott's MitraClip Approved by FDA
MitraClip, manufacturer by Abbott Vascular
Abbott (NYSE: ABT) announced today the the U.S. Food and Drug Administration has approved its MitraClip device for use in "patients with significant symptomatic degenerative MR who are at prohibitive risk for mitral valve surgery." Seven months ago the MitraClip was the topic of intense discussion by the FDA panel tasked with judging its safety, efficacy, and risk-benefit ratio. The panel voted 8-0 in favor of safety, a tie-breaking 5-4 against efficacy, but 5-3 for a favorable risk-benefit ratio.

October 22, 2013
New Recapturable CoreValve Study Starts
CoreValve Evolut R
The technical challenges with TAVI procedures that must be surmounted are many. Today, Medtronic announced that several of these limitations are being addressed in an initial study of 60 patients who will be treated with a new iteration of the CoreValve. The CoreValve® Evolut™ R Recapturable System has been designed to allow recapturing and repositioning of the valve during deployment, better conformability to an irregular annulus, and a delivery system that utilizes a smaller sheath to reduce the profile needed to access the patient vessel.

October 21, 2013
Let's Disagree to Agree: the Not-So-Great Coronary Angioplasty Debate and a Patient's Right to Speak
stents question
I read yesterday morning that I was now a party to "The Great Coronary Angioplasty Debate." (Note to self: don't look at Twitter before Sunday brunch.) This all started a week ago, when Dr. Nortin Hadler posted an op-ed piece on The Health Care Blog, titled "The End of the Era of Coronary Angioplasty." He opined that angioplasty was unnecessary in the setting of a major heart attack (a.k.a. STEMI) and might even worsen outcomes. His title and thesis was so over-the-top (intentionally so, I'm sure) that I felt obliged to pen a response to his very anti-stent article.

October 21, 2013
Medtronic Launches New Thrombus Aspiration Catheter in U.S.
Medtronic's Export Advance aspiration catheter
Today Medtronic, Inc. (NYSE: MDT) announced the product launch of its latest thrombus aspiration catheter, the Export Advance, which recently received a 510k clearance from the U.S. Food and Drug Administration. The Export Advance received the CE Mark this past May. Over one million patients have been treated using Export aspiration catheters. This latest model features a stylet, pre-loaded with a core wire that runs through the middle of the shaft to provide more support during delivery to increase deliverability and kink resistance.

October 21, 2013
Volcano Corporation Schedules Third Quarter Conference Call, Webcast
Volxano headquarters in San Diego
Volcano Corporation (Nasdaq: VOLC) today announced it will report its operating results for the third quarter of fiscal 2013 on Monday, November 4. 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, November 4, hosted by Scott Huennekens, president and chief executive officer, and John Dahldorf, chief financial officer.

October 19, 2013
For Transradial Angioplasty, "Slender and Lean" in the Netherlands
Slender Club Europe 2014: a new initiative of Slender Club Japan
Five years ago, interventional cardiologists in Japan decided that to make the transradial approach even easier, the equipment needed to be downsized, literally — and the Slender Club Japan was started, initiated by Dr. Fuminobu Yoshimachi. Interventionalists got together for workshops and meetings throughout Japan to demonstrate new innovations and techniques, "slender" techniques with miniaturized equipment. Now Dr. Ferdinand Kiemeneij, father of the trasradial approach, is bringing the Slender Club to Europe and has announced a very special kick-off meeting for the Slender Club Europe on February 14, 2014.

October 19, 2013
Medtronic Activities at TCT: CoreValve, Renal Denervation, Stents and More
Golden Gate Bridge
Medtronic, Inc. (NYSE: MDT) has announced a number of updates and presentations that will be made at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) meeting in San Francisco, the largest gathering of interventional cardiologists and related healthcare professionals in the U.S. This year marks the 25th annual TCT. Perhaps the most anticipated data for Medtronic will be from the first U.S.-based CoreValve trials of a self-expanding transcatheter heart valve in patients suffering from severe aortic stenosis.

October 17, 2013
Angioplasty, Stents or Fibrinolytic Therapy for Heart Attacks?
Dr. Charles Dotter's 'logo': angioplasty is plumbing
How does a physician treat a heart attack where the blood flow to the heart muscle is suddenly cut off by a blocked artery? In the most severe cases, the ST segments on the ECG are elevated, signalling that a major part of the heart muscle is at risk. It's called a STEMI (ST-Elevated Myocardial Infarction). And, if you subscribe to the concept that the heart and circulation are like the plumbing in your house, like Dr. Charles Dotter did (he invented the concept of angioplasty and, in his offbeat humorous way, he used the graphic to the left as his logo), then you would assume there are two major ways to treat the problem: use Drano to dissolve the blockage or use a mechanical roto-rooter to clear it out.

October 14, 2013
R.I.P. Angioplasty 1977-2013 – Really?
Nortin M. Hadler, MD, MACP, MACR, FACOEM
My first thought upon seeing this Op-Ed piece posted today on The Health Care Blog was that it was yet another article railing against the overuse of stents in patients with stable angina. But, as I continued to read the article, I saw that Dr. Hadler's premise is that angioplasty may not be necessary even in the severe cases of STEMI, and that clot-busting drugs could achieve the same outcomes at less expense and less risk for the patient. He spends most of his article discussing the recent STREAM study.

October 9, 2013
Four-Year Data for Cook's Zilver® PTX® Drug-Eluting Stent Show 41% Reduction in Restenosis over BMS
Zilver® PTX® Drug Eluting Peripheral Stent
Cook Medical's Zilver® PTX® drug-eluting stent for use in the treatment of peripheral artery disease shows excellent outcomes at four years when used in the superficial femoral artery (SFA). After four years the Zilver PTX showed a primary patency of 75% compared to only 57.9% for the BMS, representing a 41% reduction in restenosis at four-years.

October 1, 2013
No New FDA Approvals Today!
FDA website today
Obviously, with the Federal government in shut down mode, a situation precipitated by the House of Representatives' demand to delay the implementation of the already-implemented Affordable Care Act (a.k.a. Obamacare), no new device approvals will be forthcoming today, or any other day, until the U.S. Government gets an infusion of start-up capital (puns intended).

September 25, 2013
AIM-RADIAL International Master Class in New York
Dr. Olivier Bertrand
For the next three days, scores of interventional cardiologists will be gathering in New York City for the Second Annual AIM-RADIAL Master Class where they will hear talks, engage in roundtable discussions, watch live case demonstrations, and be thoroughly immersed in advanced state-of-the-art techniques, the latest data and the most current evidence-based medicine regarding all aspects of the transradial technique for diagnostic angiography and percutaneous interventions.

September 24, 2013
FDA Expands Indications for Self-Expanding Stent
Medtronic Complete SE Vascular Stent
Marking what Medtronic, Inc. (NYSE: MDT) is calling a major advance for the interventional treatment of peripheral artery disease, the FDA has expanded the indications for Medtronic's Complete SE vascular stent to treat atherosclerosis in the superficial femoral artery (SFA) and proximal popliteal artery (PPA), the vessels which carry blood through the upper legs.

September 23, 2013
Department Store Where Dr. DeBakey Found His Surgical Graft Fabric is Demolished
image
I was alerted via Twitter today that the Macy's department store, formerly Foley's, in Houston, Texas was demolished yesterday. The building has significance for the world of medicine. Foley's is where Michael DeBakey purchased a bit of Dacron fabric, which he fashioned into an arterial graft to repair an aortic aneurysm, an achievement which gave birth to the wide spectrum of medical devices we have today.

September 22, 2013
Stony Brook Heart Institute Evaluates Abbott's Absorb Bioresorbable Stent
Dr. Luis Gruberg with staff in cath lab
Specialists at Stony Brook University Heart Institute in Stony Brook, New York, have begun enrollment in a clinical trial investigating the first cardiovascular stent that opens a heart vessel the same way as metallic stents but then dissolves away naturally. The new stent could prove to have benefits over standard metallic drug-eluting stents in relation to vessel blood flow and how much natural motion returns to the vessel after it dissolves.

September 22, 2013
Open Heart: BMJ Announces a New Online Open-Access Cardiology Journal
Pascal Meier MD
This October, Open Heart, a new online only peer-reviewed cardiology journal will launch its initial website, with publication of its first round of articles targeted for early 2014. Announced at the recent European Society of Cardiology meeting in Amsterdam, Open Heart is a sister publication to Heart and the newest addition to the BMJ family, which is publishing it in partnership with the British Cardiovascular Society.

September 20, 2013
CRF Announces Late Breaking Trials and First Report Investigations to be Presented at TCT 2013
San Francisco Golden Gate Brodge
The Cardiovascular Research Foundation (CRF) has announced the late breaking trials and first report investigations that will be presented at next month's Transcatheter Cardiovascular Therapeutics (TCT) 2013 scientific symposium. TCT, the world's premier educational meeting specializing in interventional cardiovascular medicine, will take place October 28 - November 1, 2013 at The Moscone Center in San Francisco, California.

September 15, 2013
Three-Year Data for Medtronic's Renal Denervation Device Shows Sustained Lowering of Blood Pressure in Patients with Uncontrolled Hypertension
Symplicity™ Renal Denervation System
The final three-year data from Medtronic's (NYSE: MDT) Symplicity HTN-1 renal denervation trial were presented at the recent European Society of Cardiology (ESC) Congress in Amsterdam. Symplicity HTN-1 is the first and longest-running trial for this novel blood pressure treatment for patients with uncontrolled high blood pressure. The results were significant: half of the patients achieved a systolic blood pressure of less than 140 mm Hg despite having a mean systolic blood pressure of 170 mm Hg when the trial started.

September 2, 2013
Global Registry Data Confirm Symplicity™ Renal Denervation System is Safe and Effective
Symplicity™ Renal Denervation System
Six and twelve month data from 1,158 patients analyzed in the the Global SYMPLICITY Registry were announced by Medtronic, Inc. (NYSE: MDT) today at the European Society of Cardiology (ESC) Congress, being held in Amsterdam. The data show safety and efficacy of the Symplicity™ Renal Denervation System that are consistent with outcomes being seen in the Symplicity HTN-2 randomized controlled trial.

August 26, 2013
Volcano to Acquire Re-Entry Catheter from Medtronic
Pioneer Plus re-entry procedure
Volcano Corporation (Nasdaq: VOLC) is rapidly expanding its offerings for peripheral artery disease, today announcing an agreement with Medtronic (NYSE: MDT) to acquire Medtronic's Pioneer Plus product line of diagnostic ultrasound transducer and subcutaneous catheters.

August 18, 2013
Medtronic's Drug-Eluting Balloon Data for Peripheral Angioplasty Submitted to FDA
IN.PACT Drug-Eluting Balloon
Medtronic, Inc. (NYSE: MDT) announced on Thursday that it had submitted its first pre-market approval (PMA) module to the U.S. Food and Drug Administration (FDA) for the IN.PACT Admiral drug-eluting balloon (DEB), to be used in the treatment of peripheral artery disease (PAD) in the superficial femoral artery. Medtronic reports that with submission of this data, it is on track to gain FDA approval in two years, which would make it the first drug-eluting balloon available in the U.S. for use in the treatment of peripheral disease.

August 10, 2013
Volcano Corp. CEO Issues Statement About George W. Bush's Stent Procedure
Scott Huennekens
When news reports about former President George W. Bush receiving a coronary stent were published this past Tuesday, the blogosphere and twitterverse erupted. Much of the ensuing commentary and critique was directed at the circumstances and diagnostic pathway that led to Bush's angioplasty. Reacting to the many comments critiquing the decision to put a stent in Bush's artery, Scott Huennekens, the President and CEO of Volcano Corporation, one of two manufacturers of FFR catheters (St. Jude is the other), put out the following statement on Friday.

August 10, 2013
Cook's Zilver® PTX® Drug-Eluting Stent for Peripheral Disease is Back on the Market
image
Cook Medical of Bloomington, Indiana is once again shipping its Zilver PTX drug-eluting stent for use in treating peripheral artery disease. The company reports that the FDA has approved their fix of the catheter tip separation problem that prompted Cook's voluntary recall in April, followed by an FDA Class I recall a month later.


August 8, 2013
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 33rd Annual Growth Conference on Thursday, August 15. The presentation by Scott Huennekens, president and chief executive officer, will begin at 8:00 a.m., Eastern Daylight Time (5:00 a.m., Pacific Daylight Time).


August 6, 2013
George W. Bush Gets Angioplasty and Stent – Was It Necessary?
George W Bush
Former President George W. Bush received an angioplasty and stent this morning at Texas Health Presbyterian Hospital Dallas. The stent was recommended by Bush's doctors to open a blockage in one of his coronary arteries, found yesterday during what was described by Bush spokesman Freddy Ford as his annual physical exam at the Cooper Clinic in Dallas. But was this procedure necessary?

August 5, 2013
Volcano Reports Second Quarter Results; Medical Segment Revenues Increase More Than 13 Percent On A Constant Currency Basis
FFR wire
Volcano Corporation (Nasdaq: VOLC) today reported results for the second quarter and first six months of 2013. For the quarter ended June 30, 2013, Volcano reported revenues of $101.3 million, an increase of six percent on a reported basis versus the same period a year ago and 12 percent on a constant currency basis after adjusting for a negative impact of approximately $5.5 million from foreign currency. Medical segment revenues increased more than seven percent and more than 13 percent on a reported and constant currency basis, respectively.

July 20, 2013
Recycling Health News for Google Dollars, Robot Style
Robot Writing
Commentary from the Editor's Blog: For years I have been getting Google News Alerts for any articles containing the keywords angioplasty, stent, etc. But recently I've been seeing more and more stories from Toronto NewsFix, and they don't add up.



July 19, 2013
Volcano Corporation Schedules Second Quarter Conference Call, Webcast
Volcano Headquarters
Volcano Corporation (Nasdaq: VOLC) today announced it will report its operating results for the second quarter of fiscal 2013 on Monday, August 5. 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), Monday, August 5, hosted by CEO and president, Scott Huennekens, and CFO, John Dahldorf.

July 12, 2013
Medtronic Issues Statement on Ruling in Germany
Medtronic's CoreValve®
Today a court in Mannheim Germany found that Medtronic's CoreValve® System infringes a patent owned by Edwards Lifesciences (the Spenser patent). Medtronic, Inc. (NYSE: MDT) respectfully disagrees with the court's decision and intends to appeal. In a separate European Patent Office proceeding, Medtronic and others have challenged the validity of the Spenser patent. Ultimately, Medtronic believes that Edwards' patent claims will be found to be invalid, which will negate today's ruling of patent infringement.

July 10, 2013
Abbott's XIENCE Xpedition Drug-Eluting Stent Approved in Japan
XIENCE Xpedition Everolimus-Eluting Stent
Abbott (NYSE: ABT) announced this morning that the Japanese ministry has approved the company's newest generation XIENCE Xpedition™ Everolimus Eluting Coronary Stent System for use in treating coronary artery disease. This approval represents an important step forward for Abbott -- Japan is a major market for stents and Abbott's stent sales have dropped this past year, especially in the U.S.

July 9, 2013
Stents and Angioplasty via the Wrist: Not Just Evangelical Anymore
image
In our interview with Dr. Caputo, he discusses how the landscape of transradial has changed in the past 5 years from introductory "evangelical" didactic lectures to mentorship and adoption by hospitals for economic benefit and improved patient care, from basically a physician-centered to an institutional-centered concern.


July 3, 2013
Stent Wars, the Prequel: PROMUS Element "Beats" Xience
Stent Wars
Commentary from the Editor: The whole marketing message of "our stent beats your stent" has just become so Early 21st Century. Times have changed: Cordis is no longer in the coronary stent business and Boston Scientific is trading at 15% of what it was back then. And devices have changed: they have all gotten much better. These days, most drug-eluting stents studies show outcomes that are pretty close.

July 1, 2013
Cook Medical Celebrates 50th Anniversary
William A. Cook
Indiana-based medical device company Cook Medical is celebrating its golden anniversary as a company today. It was 50 years ago in 1963 that angioplasty pioneer William ("Bill") Alfred Cook started Cook Medical in the spare bedroom of his Bloomington, Indiana apartment. Today the Cook Group consists of 42 companies employing more than 11,000 people at 15 manfacturing sites in the United States, Europe, Asia and Latin America.

June 30, 2013
Past, Present & Future of Transradial Angioplasty with Dr. Ferdinand Kiemeneij
image
On the occasion of the 20th anniversary of transradial intervention (TRI), Angioplasty.Org talked with Dr. Ferdinand Kiemeneij, "the father of transradial intervention" and interventional cardiologist at OLVG, Amsterdam. In this two-part interview, we cover a wide range of topics regarding TRI, from the history of the procedure to Dr. Kiemeneij's vision of the future of TRI and what needs to happen for its ultimate worldwide acceptance as the default approach for catheter-based intervention.

June 26, 2013
Two Year Results for TWENTE Published: Medtronic Resolute and Abbott Xience Stents Show Excellent Results and Safety
Abbott Xience V and Medtronic Resolute Stents
Two year results from the TWENTE clinical trial, which compared two second-generation drug-eluting stents, are reported in the current issue of the Journal of the American College of Cardiology. At one-year, the two stents, Medtronic's Resolute zotarolimus-eluting stent and Abbott's Xience V everolimus-eluting stent, had similar clinical outcomes in 1,391 "real-world" patients, randomized 1:1 to either stent.

June 25, 2013
Training is Key to Adoption of Transradial Wrist Approach to PCI
J. Dawn Abbott, MD
An Editor's perspective piece about the transradial (wrist) approach to angioplasty and stents appears in the current issue of "Circulation: Cardiovascular Interventions." Penned by Associate Editor J. Dawn Abbott, MD, the article, titled "Diffusion of Innovations and Adoption of Transradial Intervention," explores why it has taken so long (and continues to) for the transradial approach to be adopted widely in the U.S., given that the evidence from clinical trials has been clear, and that the economic and patient comfort benefits are evident.

June 24, 2013
Stent on a Wire with Bioabsorbable Drug Coating Shows Impressive One Year Results; Ideal for Transradial Approach
Svelte Acrobat (R) w/standard stent (L)
At last month's EuroPCR meeting, the one-year results of a novel new stent showed impressive results. Although this was a small pilot first-in-human study for safety and efficacy, enrolling only 30 patients, at twelve months there were no cases of either clinically-driven target lesion revascularization or stent thrombosis. And, as measured by OCT, more than 98% of the stent struts were covered by endothelium.

June 23, 2013
Meta-Analysis Shows Benefit of Drug-Eluting Stents vs BMS Below the Knee
Frank J. Criado, MD
Guest post from Dr. Frank J. Criado, Editor in Chief of Vascular Disease Management, examines a recent meta-analysis of DES vs BMS for therapy below the knee. The study was authored by Dr. George A. Antoniou et al from the Manchester Royal Infirmary in the UK and apeared in a recent issue of the Journal of Endovascular Therapy.


June 20, 2013
USA Today Claims Stents and Angioplasty "Often Unnecessary"
Coronary Stent
Yesterday's edition of USA Today carried an article by Peter Eisler titled, "Six common surgeries often done unnecessarily" — and, you guessed it, angioplasty and stents were at the top of the list. I was a bit taken aback because I was not aware of any new study, federal or independent, that concluded stents were being vastly over-used. And it turns out that there wasn't one.

June 14, 2013
Become Part of the Transradial Angioplasty Surge
transradial access
We estimate that by the end of 2013, TRI will account for 20% of all PCIs. That's one in five. Pretty impressive. When was the last time a medical procedure that is less expensive, more comfortable for patients and has fewer complications, grew this quickly? You can read more in our article, "Wrist Angioplasty Sees Unprecedented Growth in U.S.," which reports on an important study which was published in this week's Circulation. Or you can do something about it and become part of this revolution by getting into the training loop.

June 10, 2013
Wrist Angioplasty Sees Unprecedented Growth in U.S.
Growth of radial access in U.S.
In tomorrow's issue of Circulation, a landmark analysis of almost 3 million coronary interventions performed in the U.S. from 2007 to 2012 concludes that utilization of the transradial approach, in which balloons and stents are delivered to the heart via the radial artery in the wrist instead of the femoral artery in the groin, has increased 13-fold in the past five years.

June 4, 2013
St. Jude Medical Initiates First US Clinical Study of the EnligHTN Renal Denervation System for Drug-Resistant High Blood Pressure
EnligHTN™ Renal Denervation System
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval to begin the EnligHTN IV Renal Denervation Study, the first U.S. trial using the EnligHTN™ Multi-Electrode Renal Denervation System to treat patients with drug-resistant high blood pressure.


June 3, 2013
Drug-Eluting Balloon One Step Closer to FDA Submission as Medtronic Completes Enrollment for IN.PACT Admiral Study
IN.PACT Drug-Eluting Balloon
Medtronic, Inc. (NYSE: MDT) announced today that its IN.PACT Admiral drug-eluting balloon clinical program had reached the enrollment needed to support submission to the FDA for approval to use this novel device in the treatment of peripheral disease, specifically blockages in the superficial femoral artery. Although the IN.PACT family of drug-eluting balloons (DEB) have been available in Europe for over four years, no drug-eluting balloons have been approved for use in the United States.

May 31, 2013
Endurant AAA Stent Graft Delivers Durable Outcomes for Abdominal Aortic Aneurysm Repair
Endurant AAA stent graft system
The Endurant AAA stent graft system from Medtronic, Inc. (NYSE: MDT) continues to distinguish itself, with new data on the market-leading device for the endovascular repair of abdominal aortic aneurysms demonstrating durable clinical performance through three years of patient follow-up. The data show 100 percent freedom from aneurysm-related mortality, 0 percent post-implant aneurysm rupture, 0 percent stent graft migration and 0 percent conversion to open repair for the 107 patients followed to three years.

May 30, 2013
New Medtronic Stent Graft and Sheath for AAA Repair Gets FDA Approval
Endurant II AUI Stent Graft
Medtronic today announced FDA approval for the newest additions to its endovascular aortic aneurysm repair product line: the Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System and the Sentrant Introducer Sheath. The company also announced that these devices will be on exhibit at the Medtronic booth during the Society for Vascular Surgery's "Vascular Annual Meeting 2013," which starts today May 30 and runs through the weekend at the Moscone Center in in San Francisco.

May 26, 2013
CE Mark Approval for Abbott's 48mm XIENCE Xpedition: World's Longest Drug-Eluting Stent
XIENCE Xpedition Everolimus-Eluting Stent
Abbott (NYSE: ABT) announced this week that it has gained European CE Mark approval for its 48mm XIENCE Xpedition everolimus-eluting coronary stent, making it the longest coronary stent currently available. Prior to this approval, the longest drug-eluting stent (DES) was 38mm, available from several manufacturers.


May 25, 2013
Oldest Stent Patient is Also Oldest Transradial Patient
Dr. Purshotam Lal and his 104-yr-old patient, Hari Singh
Pretty amazing! Last week a 104-year-old man from Noida, India became reportedly the oldest patient ever to receive an angioplasty and stent. As reported in the Hindustan Times, Hari Singh was admitted to Metro Hospital and Heart Institute on May 16 with chest pain. Angiography showed two 100% totally occluded arteries and a 90% blockage near the origin of his Left Anterior Descending (LAD) artery.

May 24, 2013
FDA Issues Class I Recall of Zilver® PTX® Drug-Eluting Stent
Zilver® PTX® Drug Eluting Peripheral Stent
Today the U.S. Food and Drug Administration issued a Class I recall of the Zilver PTX Drug-Eluting Peripheral Stent. One month ago, Cook Medical, the device manufacturer, issued its own voluntary recall. It was not immediately clear as to why the FDA has now issued its own recall.


May 23, 2013
Medtronic's In.Pact Falcon Drug-Eluting Balloon Yields Positive Outcomes in Small Coronary Arteries
IN.PACT Drug-Eluting Balloon
One-year data from an Italian multicenter randomized controlled trial of the IN.PACT Falcon drug-eluting balloon from Medtronic, Inc. (NYSE: MDT) demonstrate positive and durable clinical results with the novel angioplasty device in the treatment of stenotic de novo lesions in small coronary arteries. The new data come from the BELLO (Balloon Elution and Late Loss Optimization) study, which enrolled 182 patients across 15 hospitals in Italy to evaluate the safety and effectiveness of two medical devices: Medtronic's IN.PACT Falcon drug-eluting balloon (DEB) and the Taxus drug-eluting stent (DES) from Boston Scientific Corp.

May 23, 2013
Medtronic CoreValve® System Gains First Approval for Transcatheter Valve-In-Valve Procedures
Medtronic CoreValve® Evolut(TM) in a surgical bioprosthetic valve (
Medtronic, Inc. (NYSE: MDT) today announced it has received Conformité Européenne (CE) Mark for valve-in-valve (VIV) procedures using the CoreValve® and CoreValve® Evolut(TM) transcatheter aortic valve implantation (TAVI) systems in degenerated bioprosthetic surgical aortic valves. This is the first ever regulatory approval for VIV procedures, which provide a minimally invasive treatment option for patients whose surgical aortic valves have degenerated, and who are at extreme or high risk for surgery and would otherwise go untreated.

May 23, 2013
Medtronic Gains European Approval for New Thrombus Removal System
Medtronic's Export Advance aspiration catheter
This week Medtronic, Inc. (NYSE: MDT) announced that the most recent addition to its portfolio of aspiration catheters, the Export Advance, has received the CE Mark and will soon be launched in Europe and other markets. To date, over one million patients have been treated using Export aspiration catheters.


May 22, 2013
For Bifurcation Lesions in Coronary Arteries, Medtronic's Resolute Stent Delivers Strong Long-Term Results
Addressing one of the most common clinical challenges in the treatment of complex coronary artery disease, three separate analyses on the program for EuroPCR this week show how strongly the Resolute drug-eluting stent from Medtronic, Inc. (NYSE: MDT) performs in coronary bifurcation lesions over the long term.


May 21, 2013
Verrata™ Pressure Guide Wire and iFR® (Instant Wave-Free Ratio™) Software Modality Will Be on Display at EuroPCR 2013
Instant Wave-Free Ratio
Volcano Corporation (NASDAQ: VOLC) today announced that it will demonstrate the Verrata™ Pressure Guide Wire and the iFR® (Instant Wave-Free Ratio™) modality throughout the week during the EuroPCR 2013 Congress in Paris, France. These two interventional tools are intended to help physicians guide more procedures and make more decisions based on actual heart function, rather than relying on the angiogram alone.

May 20, 2013
Volcano to Highlight its Physiology Expansion Efforts at EuroPCR 2013
image
Volcano Corporation (NASDAQ: VOLC) today announced it will highlight its efforts to expand research and innovation surrounding its physiology technologies, including its Fractional Flow Reserve (FFR) and iFR® (Instant Wave-Free Ratio™) technologies, via various clinical and educational presentations and events at EuroPCR 2013 in Paris.


May 15, 2013
Transradial Approach Surging in the U.S.
image
Interventional cardiologists…listen up!! Stent and angioplasty procedures in the United States are now done through the wrist 15-20% of the time. This is a big change! And, according to Dr. Sanjit Jolly of McMaster University in Hamilton, Canada, in three to five years, half of all U.S. procedures will be done through the wrist. Get that interventional cardiologists? HALF!

May 2, 2013
Volcano Announces First Quarter Results
image
Volcano Corporation (Nasdaq: VOLC) today reported results for the first quarter of 2013. For the quarter ended March 31, 2013, Volcano reported revenues of $93.2 million, an increase of three percent on a reported basis versus the same period a year ago and eight percent on a constant currency basis after adjusting for a five percent negative impact from foreign currency. Medical segment revenues increased four percent and nine percent on a reported and constant currency basis, respectively.

April 29, 2013
Medtronic Reports Initial Implants of Novel Stent Graft for Aortic Aneurysms Involving Branch Vessel
Medtronic's Valiant® Mona LSA System Thoracic Stent Graft System
Vascular specialists at Carolinas HealthCare System in Charlotte, N.C., and the Cleveland Clinic in Ohio recently performed the initial implants of a novel stent graft system from Medtronic, Inc. (NYSE: MDT) as part of a U.S. Food and Drug Administration (FDA) initiative designed to encourage more early-stage clinical research on new medical devices in the United States. These implants were among the first to be performed under this FDA early feasibility pilot program, which includes a total of nine medical devices from different companies.

April 29, 2013
Andreas Gruentzig on "Complications"
Andreas Gruentzig, MD -- Inventor of PTCA
Commentary from the Editor's Blog: The paradox of low occurrence of complications yet high impact on the individual has been around for a long time, but I always remember the comments of Andreas Gruentzig, the inventor of coronary angioplasty, when I interviewed him in 1985. Gruentzig, ever conscious of the patient, discussed the question of complications and had very specific thoughts about the physician's role. See the video.

April 28, 2013
Dr. Ajay Kirtane Named Co-Director of TCT 25
Dr. Ajay J. Kirtane
The TCT (Transcatheter Cardiovascular Therapeutics) annual meeting is, according to its organizers, the world's largest and most important conference in interventional cardiovascular medicine. And this year marks the 25th Anniversary of the TCT (note: the entire field of interventional cardiology is only 36 years of age). This year also marks Dr. Ajay Kirtane's role as an official Co-Director of the TCT, in recognition of his contributions and dedication to the meeting.

April 25, 2013
ESC Recommends Patients and Centres for Renal Denervation
ESC logo
Up to 10 percent of patients with high blood pressure are resistant to treatment, which puts them at increased risk of cardiovascular events, including heart attacks. Clinical trials show that catheter-based renal denervation reduces blood pressure in patients who do not respond to conventional drug therapy. Use of the technique is increasing in Europe and worldwide and several National Societies have published guidance on which patients with hypertension should receive treatment. The European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) decided it was time for a European view and have developed an expert consensus document on catheter-based renal denervation.
April 22, 2013

Volcano Corporation Schedules First Quarter Conference Call, Webcast
Volcano HQ
Volcano Corporation (Nasdaq: VOLC) today announced it will report its operating results for the 1st quarter of fiscal 2013 on Thurs, May 2. The company will hold a conference call to discuss its financial results and operating activities open to all interested parties at 2 p.m., PDT (5 p.m., EDT), Thursday, May 2, hosted by Scott Huennekens, president and chief executive officer, and John Dahldorf, chief financial officer.

April 22, 2013
Shalom Jacobovitz Named CEO of American College of Cardiology
Shalom
The American College of Cardiology Board of Trustees today announced that Shalom "Shal" Jacobovitz has been selected as the college's chief executive officer. "Shal has a track record that demonstrates he is the right person to lead a strong organization like the ACC and to take it to the next level at a time when health care is undergoing massive changes," said ACC President John Gordon Harold, MD, MACC.

April 18, 2013
Medtronic Stent Data for Diabetic Patients Published
Medtronic's Resolute Integrity zotarolimus-eluting coronary stent
This week the Journal of the American College of Cardiology: Cardiovascular Interventions published an article detailing the two-year pooled analysis of outcomes from Medtronic's international RESOLUTE Global Clinical Program of over 5,100 patients: how this data showed positive results for the interventional treatment of patients with diabetes, and how these outcomes led the FDA to approve the Resolute Integrity for use in diabetic patients.

March 20, 2013
FDA Panel Recommends MitraClip for Approval
MitraClip from Abbott Vascular
Today the FDA Circulatory System Devices Panel spent many hours listening to testimony from Abbott Vascular, surgeons, cardiologists and patients about the MitraClip Clip Delivery System in order to decide in a final vote whether to recommend that the FDA approve the device for indication in patients too sick or not eligible for surgical mitral valve replacement, but healthy enough so that this device would provide significant benefit.

March 20, 2013
FDA Panel Decision on Mitraclip Approval: It's Safe and "Sort of" Effective
MitraClip, manufactured by Abbott Vascular
Today's FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee heard testimony from Abbott Vascular, surgeons, cardiologists and patients about the MitraClip Clip Delivery System and what its recommendations to the FDA would be regarding approval of the device. The votes were 8-0 on safety, 5-4 against efficacy, and 5-3 for a favorable risk-benefit ratio.

March 14, 2013
Volcano Enters Microcatheter Market with Launch of Valet Microcatheter
Valet® microcatheter
Volcano Corporation (NASDAQ: VOLC) is best known for its angioplasty and stent optimization technologies of intravascular ultrasound (IVUS) imaging catheters, virtual histology (VH) software and its line of fractional flow reserve (FFR) functional measurement devices. Today the company announced the launch of an entirely new microcatheter product line, starting with the Valet® Microcatheter.

March 14, 2013
No Stent Thrombosis Seen When Plavix and Aspirin Stopped Early
Resolute Stent in Artery
Important news for stent patients and cardiologists alike: data from a new analysis of Medtronic's (NYSE: MDT) RESOLUTE drug-eluting stent program show very low occurrence of stent thrombosis when dual antiplatelet therapy (DAPT) is interrupted or discontinued after one month.


March 7, 2013
Medtronic Renal Denervation Program Advances in U.S.
Symplicity™ Renal Denervation System
Medtronic, Inc. (NYSE: MDT) has announced two landmarks in its quest to bring the first renal denervation system to market in the United States. The Symplicity™ Renal Denervation System is currently available in Europe, but no renal denervation system is yet available in the U.S. In fact Medtronic is the only company currently running a pivotal clinical trial, aimed at FDA approval.

March 4, 2013
Volcano Corporation Announces Presentations At Upcoming Investor Conferences
image
Volcano Corporation (Nasdaq: VOLC) said today that it will be participating in two upcoming investor conferences. On Tuesday, March 12, the company will participate in the Barclays Global Healthcare Conference 2013, and on Monday, March 18, the company will participate in the 25th Annual Roth Conference.


March 4, 2013

Medtronic Stent Gets CE Mark Label Update for One Month of DAPT
image
Medtronic, Inc. (NYSE: MDT) today announced that its Resolute Integrity drug-eluting stent has received CE Mark approval for a labeling update to read, "...patients who interrupt or discontinue DAPT medication one month or more after stent implantation are considered at low risk and showed no increased risk for stent thrombosis." The Conformité Européenne decision was based on an analysis of 5,000 patients enrolled in the RESOLUTE Clinical Program, which at one year showed no stent thrombosis in the 907 patients who discontinued dual antiplatelet therapy (DAPT) after one month.

February 28, 2013
Transradial on the Hudson
Hudson River separates New York and New Jersey
For interventional cardiologists in the Northeast, the next few months offer two important transradial training opportunities…on both sides of the Hudson River: in New Jersey, on April 20, will be the Mid-Atlantic Radial Symposium (MARS2013); and in New York, on June 28-29, will be the NYCTRAC, organized by the Cardiovascular Research Foundation.


February 28, 2013
Medtronic's Engager™ Transcatheter Aortic Valve Gets European Approval
Medtronic's Engager™ Transcatheter Aortic Valve
Today Medtronic (NYSE: MDT) announced that its Engager™ Transcatheter Aortic Valve Implantation (TAVI) System with transapical delivery catheter has received the European CE Mark. This new system, which demonstrated positive clinical outcomes in its European Pivotal Trial, will offer a new option for patients with severe aortic stenosis who are at high risk for surgical aortic valve replacement.

February 26, 2013
Volcano Corporation Announces Webcast Of March Seventh Analyst Day
NASDAQ MarketSite
Volcano Corporation (Nasdaq: VOLC), a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, will hold its 2013 Analyst Day on Thursday, March 7, at the NASDAQ MarketSite in New York City. A webcast of the event will begin at 10 a.m., Eastern Standard Time (7 a.m., Pacific Standard Time) and conclude at approximately 2 p.m., Eastern Standard Time (11 a.m., Pacific Standard Time).

February 25, 2013
Long-Length Drug-Eluting Stent from Medtronic Gets FDA OK
Medtronic's Resolute Integrity Drug-Eluting Stent
Medtronic Inc. (NYSE: MDT) announced this morning that its Resolute Integrity zotarolimus-eluting stent was approved by the FDA in two additional longer lengths, 34mm and 38mm. As the only drug-eluting stent (DES) currently approved by the FDA specifically for use in diabetic patients, the availability of stent lengths that can be used in long lesions, which are more common in diabetics, solidifies the positioning of the Resolute Integrity as a primary choice for the treatment of coronary artery disease in these patients.

February 21, 2013
Volcano Reports Fourth Quarter Revenue Up 10%; Fractional Flow Reserve Revenue Up 45% for Year
Fractional Flow Reserve
Volcano Corporation (NASDAQ: VOLC) today reported its fourth quarter revenue which was $102.5 million, up 10% over the same period last year. Leading the increased revenue were disposables in Volcano's fractional flow reserve business, which were up 45% on an annual basis. While the adoption of FFR has lagged behind the clinical data, Volcano's reported 45% increase in revenue definitely points to increasing use of this technology to optimize stent placement and decision-making.

February 19, 2013
Medtronic Drug-Eluting Stent Revenue Up 42%
Medtronic's Resolute Integrity Drug-Eluting Stent
Medtronic, Inc. (NYSE: MDT) today announced financial results for the third quarter of fiscal year 2013, which ended January 25, 2013. One of fastest growing segments of this $4 billion company was the coronary division which grew 19% overall. Fueled by sales of its Resolute Integrity Zotarolimus-eluting stent, approved last year in the U.S. and Japan, drug-eluting stent quarterly revenue was up 42% to $274 million.

February 18, 2013

No More Financial Assistance for Plavix from Bristol-Myers But Are Generics Really the Same?
Plavix and stent
Bristol-Myers Squibb (NYSE: BMY) is no longer offering its $37-a-month Plavix® Co-Pay Discount Card. And some patients are not happy about this. Additionally, according to the company's web site for "Patient Assistance Programs," the company is no longer making this life-saving drug available to patients who cannot afford it. This, of course, has something to do with the fact that brand-name Plavix has gone off patent and generic versions have been available since May 2012. But are the generic versions of clopidogrel really the same?

February 15, 2013
Can Renal Denervation Reduce Heart Attack, Stroke and Death?
EnligHTN™ Renal Denervation System
Renal denervation, a catheter-based procedure designed to lower blood pressure, has been the subject of much interest to the interventional community over the past couple of years. Although high blood pressure puts one in three adults worldwide at risk of heart attack, stroke and kidney failure, the renal denervation studies that have been conducted to date have looked only at reducing blood pressure rather than the overall impact on major cardiac events. St. Jude's (NYSE:STJ) announcement today of the EnligHTNment trial is the first that will look at "hard end points" such as heart attack, stroke and mortality.

February 13, 2013
Medtronic Announces FDA Approval and Launch of Its Advisa MRI Pacemaker System
Advisa DR MRI™ SureScan® pacemaker
Medtronic, Inc. (NYSE: MDT), today announced FDA approval and U.S. launch of its Advisa DR MRI™ SureScan® pacing system. The Advisa MRI system is Medtronic's second-generation MR-Conditional pacemaker and is the first system to combine the most advanced pacing technology with proven MRI access.


February 11, 2013

Medtronic to Announce Financial Results for Its Third Quarter of Fiscal Year 2013
image
Medtronic, Inc. (NYSE: MDT) announced today it will report financial results for the third quarter of its fiscal year 2013 on Tuesday, February 19, 2013. A news release will be issued at approximately 6:15 a.m. Central Time and will be available at www.medtronic.com/newsroom. The earnings news release will include summary financial information for Medtronic's third quarter, which ended January 25, 2013. Medtronic will host a webcast at 7 a.m. Central Time to discuss financial results for its third quarter.

February 11, 2013
Volcano Corporation Schedules Fourth Quarter Conference Call, Webcast
image
Volcano Corporation (Nasdaq: VOLC) today announced it will report its operating results for the fourth quarter of fiscal 2012 on Thursday, February 21. 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, February 21.

February 6, 2013
St. Jude Begins Expanded Renal Denervation Study
EnligHTN™ Renal Denervation System
St. Jude Medical has announced enrollment of the first patient in the EnligHTN II trial, a post-market clinical study that will further evaluate the safety and efficacy of the EnligHTN™ Renal Denervation System in patients with uncontrolled hypertension. This expanded study will enroll 500 patients in 40 centers throughout Europe and Australia with five year follow-up.

February 6, 2013
Novel Catheter-Based Treatment for Heart Failure Begins U.S. Trial
Parachute device
CardioKinetix, Inc., a medical device company, based in Menlo Park, California, recently announced the start of a major U.S.-based trial for their Parachute™ Ventricular Partitioning Device, the first catheter-based treatment for heart failure. Implanted in a procedure similar to coronary angioplasty and stents, initial smaller trials for the device have shown positive results at two and three years. As a result of this data, the Parachute currently is approved for use in Europe and carries the CE Mark. The PARACHUTE IV Trial expects to enroll 478 patients in the U.S.

February 1, 2013
Volcano Announces New iPad Teaching Application for Its Recently-Released Visions® PV .035 Digital IVUS Catheter
Aortic IVUS App
Volcano Corporation (Nasdaq: VOLC) today announced it has a new interactive educational tool to facilitate learning about IVUS-guided interventional procedures with its new Visions® PV .035 Digital IVUS Catheter. The new Aortic IVUS App for iPad, available on the Apple App Store, provides case examples with interactive education on the procedural workflow and image interpretation, and is intended for healthcare professionals involved in endovascular aortic procedures.

January 28, 2013
European Society of Cardiology: "Transradial Access Should Be 1st Choice for Angioplasty"
Transradial Access
This is very big news. Today the European Association of Percutaneous Cardiovascular Interventions (EAPCI), the Acute Cardiovascular Care Association (ACCA) and the Working Group (WG) on Thrombosis of the European Society of Cardiology (ESC) published their joint consensus document on the radial approach to PCI, online ahead of print in EuroIntervention.

January 27, 2013
Follow-up to Transradial Angioplasty on the Dr. Oz Show
Dr. Jennifer Tremmel
Last month Dr. Oz did a segment on transradial angioplasty and featured Dr. Jennifer Tremmel. But while what Dr. Tremmel discussed was certainly of interest to Dr. Oz's lay audience, the story of how she came to practice the transradial approach is most instructive for those interventional cardiologists who are thinking about learning the radial technique.

January 24, 2013

Medtronic Launches Lower-Extremity Indication for Complete 'SE' Vascular Stent Internationally
Medtronic's Complete SE Vascular Stent
Expanding its role in the treatment of peripheral artery disease, Medtronic, Inc. (NYSE: MDT) today announced the CE (Conformité Européene) mark and international launch of its Complete SE (self-expanding) vascular stent for use in the lower extremities –– specifically, the superficial femoral arteries (SFA) and proximal popliteal arteries (PPA), which supply blood to the legs. In the U.S., the Complete SE stent is approved by the FDA only for use in the iliac arteries. Its use in lower-extremity arteries in the United States is under review by the FDA.

January 23, 2013
Back to the Future: Drug-Eluting Angioplasty Balloons, Dissolving Stents, FFR and More
image
When I have interviewed Drs. Nico Pijls, Bernard De Bruyne, William Fearon, and Justin Davies, proponents of the modern-day fractional flow reserve (FFR) technology, I asked, "Isn't FFR the modern version of what Andreas Gruentzig was doing with pressure gradients when he first invented coronary angioplasty almost four decades ago?" And the answer was, "Absolutely, yes!"

January 23, 2013
Medtronic Drug-Eluting Balloon Study Completes Enrollment
IN.PACT Drug Eluting Balloon
Medtronic, Inc. (NYSE: MDT), today announced completion of enrollment in IN.PACT SFA II, the U.S. arm of its clinical study for the IN.PACT Admiral drug-eluting balloon as a treatment for peripheral artery disease in the superficial femoral and proximal popliteal arteries (SFA and PPA). Results of IN.PACT SFA II will be combined with those from IN.PACT SFA I, which previously completed enrollment of 150 patients in Europe, to support a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA).

January 14, 2013
Transradial Training in the Northwest
Seattle skyline
Swedish Medical Center and the Seattle Science Foundation are teaming up once again to provide training in the transradial (or wrist) approach for interventional cardiologists. Titled "The Transradial Approach: A Case-based and Hands-on Training Course," this two-day course runs from March 1-2, 2013.


January 8, 2013
A New Year's Non-Resolution for Angioplasty and Stent Patients…and more
The Activated Patient
Check out the first post of 2013 on our new blog. "The Activated Patient." It's titled "Singing On The Table: Be Activated in 2013 with a Non-Resolution" and it's all about what it means to be "activated" — not just for heart patients, but for the rest of us as well.


January 8, 2013
Singing On The Table: Be Activated in 2013 with a Non-Resolution
Tenor
We spent a long time choosing a name for this blog: the empowered patient, the informed patient, the educated patient, the engaged patient, we tossed around many of the trending terms that signal a more patient-centered attitude toward heart health. But activated stuck because, like that tenor's will to sing, it seems to capture a quality that belongs to the patient and comes from within – not something health professionals do to patients (educate, inform), or permit (empower, engage), but something patients summon up and create for themselves.

January 7, 2013
Volcano Corporation Announces Record Preliminary Fourth Quarter 2012 Revenues
Fractional Flow Reserve wire
Volcano Corporation (Nasdaq: VOLC) said today that it expects total revenues for the fourth quarter of 2012 will be approximately $102.5 million, bringing expected full year 2012 revenues to approximately $381.9 million.

Click here for more information about the following ads