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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 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.

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 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.

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 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 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.

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 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).

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
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 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 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.

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 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 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.

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
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 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?

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 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 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 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 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 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 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.

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 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
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 4, 2013
Medtronic Stent Gets CE Mark Label Update for One Month of DAPT
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
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 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 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 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.

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

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).

December 5, 2012
New Guidelines for Stable Heart Disease: Emphasis on Patient Involvement, "Holistic" Approach
The first major revision in a decade of the guidelines for patients with stable ischemic heart disease (SIHD) will be published later this month, but the 100+ page document is now available online. Seven major medical societies have issued this consensus document, detailing the evidence and key issues involved in the diagnosis, risk assessment, treatment and follow up of known or suspected SIHD plus a wide variety of additional topics -- but throughout the recommendations, guideline-directed medical therapy (GDMT) is the cornerstone of treatment for most patients, and patient involvement in that therapy is critical. (Read more...)

December 1, 2012
Ad Hoc Angioplasty: A Consensus Update from SCAI
Although there are a number of benefits to performing both the diagnosis and interventional therapy in the same sitting, as in the case of heart attacks, the changing landscape of coronary artery disease treatment and recent concern about the overuse of stenting has prompted SCAI, the professional organization serving the interventional cardiology community, to issue a consensus statement as a guide to when ad hoc PCI should and should not be the default treatment pathway. (Read more...)

December 1, 2012
Ad Hoc Angioplasty: The Patient Is On The Table
Commentary from the Editor's Blog: Something that is "on the table" is defined as an item that is "up for discussion." And this week The Society for Cardiac Angiography and Interventions (SCAI) issued a consensus statement about the proper use of "ad hoc PCI" — and the patient was definitely on the table, up for discussion, part of the conversation. (Read more...)

November 27, 2012
Stents, Trials and Studies: What's in a Word?
Today the editors of the HEART Group Journals issued a "Statement on Matching Language to the Type of Evidence Used in Describing Outcomes Data." Although the title of the article may be a bit yawn-inducing, the editors deserve a kudo or two for attempting to clarify reporting on medical issues. (Read more...)

November 15, 2012
FDA Approves Cook's Zilver PTX: the First Drug-Eluting Stent to Treat Peripheral Arterial Disease
Today the FDA approved the Zilver® PTX® Drug-Eluting Peripheral Stent, the first drug-eluting stent indicated to re-open a particular artery in the thigh (femoropopliteal artery) when narrowed or blocked as a result of peripheral artery disease (PAD). The okay comes more than a year after the FDA Advisory Committee unanimously recommended approval of the device. (Read more...)

November 15, 2012
Angioplasty: From the Legs to the Heart and Back to the Legs
What was some of the big news at this year's TCT meeting? The use of catheter-based procedures in the peripheral vessels: the legs, the kidneys. Some of the major newsworthy device stories were concerned with drug-eluting balloons and stents and new atherectomy devices for opening the leg arteries, not to mention renal denervation procedures in the kidneys to lower refractory high blood pressure. But the main thought here is that a simple idea which started very modestly half-a-century ago to treat peripheral disease in the legs, took a journey to the heart, and is now being studied intensely again to solve the problem of critical limb ischemia. (Read more...)

November 14, 2012
Largest Prospective Study Shows IVUS-Guided Stent Placement Improves Patient Outcomes with Current Generation of Stents
Results from 3,349 patients, the largest study of its kind, show that stent procedures guided by intravascular ultrasound (IVUS) resulted in better patient outcomes and fewer complications at 30 days and 12 months compared to procedures without IVUS, and were safe. (Read more...)

November 6, 2012
A Stent By Any Other Name Now Has Other Names!
The ACC Appropriateness Use Criteria Working Group has just approved changes in terminology. PCIs will no longer be categorized as "uncertain" or "inappropriate." (Read more...)

October 30, 2012
The Question of Angioplasty in the Elderly
Commentary from the Editor's Blog: Imagine you are an 85-year-old suffering from severe angina. Your daily activity is being diminished. Your concern isn't so much whether angioplasty will improve mortality (you are already well past the "average" life span); your major concern is that you want to live each day that you have to the fullest. (Read more...)

October 30, 2012
Bare Metal or Drug-Eluting Stents in Octogenarians? Results from the XIMA Trial
The one-year results of the XIMA trial of patients 80 years of age or older were presented by Dr. de Belder at the Transcatheter Cardiovascular Therapeutics late-breaking trials session on October 26. The primary composite endpoint (comprising death, major bleeding, MI, TVR, and CVA) showed no statistically significant difference between the use drug-eluting (14.5%) or bare metal stents (18.7%) in this seldom studiend patient population. (Read more...)

October 23, 2012
Medtronic Stent Successfully Treats Long Lesions And Small Vessels, Two Characteristics Typical Of Patients With Diabetes, In Multiple Studies
For the treatment of long lesions and small vessels –– two challenging characteristics of coronary artery disease commonly found in patients with diabetes –– the Resolute drug-eluting stent from Medtronic, Inc.(NYSE: MDT) delivered successful clinical results, according to new data presented at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. (Read more...)

October 22, 2012
Analysis Of Medtronic Stent Finds Early Cessation Of Dual Antiplatelet Therapy Caused No Increased Risk Of Blood Clots To One Year
Interrupting dual antiplatelet therapy after 30 days following the implantation of a Resolute drug-eluting stent from Medtronic, Inc. (NYSE: MDT) caused no increase in rates of stent thrombosis at one year, according to a new analysis of the global RESOLUTE clinical program presented today at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. (Read more...)

October 17, 2012
"Annual Report" of Stent Procedures Shows Big Increase in Wrist Angioplasty
Today's report from the ACC CathPCI Registry data has some interesting statistics, among them a significant increase in the transradial approach, in which balloons and stents are directed to the heart via the radial artery in the wrist. (Read more...)

October 17, 2012
Registry Report Provides Snapshot of Interventional Cardiology Data Analyzed From Over 2 Million Procedures
A report from the CathPCI Registry, a data registry that includes information from 85% of the heart catheterization laboratories in the United States, analyzes data from 1.1 million patients undergoing diagnostic cardiac catheterization procedures and 941,248 patients who underwent angioplasty and stenting, known as percutaneous coronary intervention or PCI, from Jan. 1, 2010, through June 30, 2011. (Read more...)

October 16, 2012
Fewer Heart Attack Victims Treated with Angioplasty and Stents in States with Mandatory Public Reporting
A study, appearing in the current Journal of the American Medical Association (JAMA), looked at almost 100,000 heart attack patients in ten Northeastern states and found that, in those states where public reporting of outcomes was mandatory, 12% fewer angioplasty and stent procedures were performed. This is an significant observation because angioplasty (a.k.a. PCI, or Percutaneous Coronary Intervention) is considered the "gold standard" for the treatment of heart attacks. (Read more...)

September 28, 2012
Medtronic Launches Stent for Diabetics in India; Abbott Launches Absorb "Scaffold"
Commentary from the Editor's Blog: According to reports yesterday by the Mumbai Bureau of Pharmabiz, and confirmed today by MassDevice, Medtronic has launched its Resolute Integrity Drug-Eluting Stent (DES) in India for the treatment of coronary artery disease (CAD). The Resolute Integrity is the only stent approved by the FDA for use in diabetics, based on a large cohort of diabetic patients in the Resolute clinical program. (Read more...)

September 28, 2012
Abbott Launches Disappearing Stent: the Absorb™ Bioresorbable Vascular Scaffold
Abbott Laboratories (NYSE: ABT) this week announced the international launch of Absorb™, the world's first drug-eluting bioresorbable vascular scaffold (BVS). The device will now be available across Europe and parts of Asia Pacific and Latin America. Abbott received the CE Mark approval for Absorb back in January 2011, but the disappearing stent, or "scaffold" as the company calls it, was not widely distributed until now. (Read more...)

September 26, 2012
Medtronic Gains CE Mark for CoreValve® Evolut™ 23mm Transcatheter Aortic Valve
Medtronic, Inc. (NYSE: MDT) today announced it has received CE (Conformité Européenne) Mark for its Medtronic CoreValve® Evolut™ 23mm valve, its latest self-expanding transcatheter aortic valve implantation (TAVI) system. The new valve incorporates technology that optimizes fit, thereby promoting sealing between the prosthetic valve and the native valve (TruFit™ Technology). (Read more...)

September 15, 2012
Results of the ADVISE Registry Published
Commentary from the Editor's Blog: A new method for the functional measurement of intracoronary pressures and the severity of blockages has been developed by researchers at Imperial College in London. Called Instant Wave-Free Ratio™ (iFR) it does not require injection of a vasodilator drug, such as adenosine. The comprehensive results of the ADVISE Registry (ADenosine Vasodilator Independent Stenosis Evaluation) were recently presented at EuroPCR by Dr. Justin E. Davies in May and have now been published online ahead of print in EuroIntervention. (Read more...)

September 12, 2012
Health-Economic Analysis Suggests Medtronic Symplicity™ Renal Denervation System Is Cost-Effective and May Reduce Cardiovascular Event Risks for Patients with Treatment-Resistant Hypertension
The Markov model used for this analysis estimated the discounted incremental cost-effectiveness ratio (ICER) of renal denervation with the Symplicity system in U.S. dollars per quality-adjusted life year (QALY) was $3,071 – well below the recognized threshold of $50,000/QALY. The Symplicity system is available in the United States for investigational use only. The model also projected that, over 10 years, renal denervation plus Standard of Care (SoC), treatment with three or more anti-hypertensive medications, could reduce cardiovascular mortality by 30 percent and all-cause mortality by 15 percent compared to SoC alone. (Read more...)

August 29, 2012
Medtronic Completes High Risk Patient Enrollment in CoreValve® U.S. Pivotal Trial and Gains FDA Approval to Study Intermediate Risk Patients in Global SURTAVI Trial
Medtronic, Inc. (NYSE: MDT) has reached two clinical program milestones for its CoreValve® System in the United States. First, it completed enrollment in its study of high risk patients in its CoreValve® U.S. Pivotal Trial, which concludes the total Trial enrollment of more than 1,500 patients with severe aortic stenosis who are at high or extreme risk for aortic valve surgery. In addition, Medtronic received FDA conditional approval to begin evaluating the CoreValve System in patients at intermediate risk for open-heart aortic valve replacement as part of the Medtronic CoreValve Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) Trial. (Read more...)

August 29, 2012
Medtronic and Volcano Pen Strategic Alliance to Offer Cardiac Cath Labs Stents, Balloons, Guide Wires, IVUS, FFR and More
This alliance means that hospital systems can now be supplied via a single contract not only the fastest-growing drug-eluting stent in the U.S. (and best-selling DES worldwide), the Resolute Integrity, but also the market-leading intravascular ultrasound (IVUS) system to help place that stent accurately, as well as the fractional flow reserve (FFR) tools to help decide if stenting is the best treatment for the patient, as the FAME and FAME 2 trials have shown. (Read more...)

August 28, 2012
Medtronic Launches Resolute Integrity Coronary Stent System in Japan
Medtronic, Inc. (NYSE: MDT) announced today the launch of the Resolute Integrity™ Coronary Stent System in Japan, the world's second largest market for medical devices. (Read more...)

August 27, 2012
Drug-Eluting Stents Are Safe
Three year results from the largest randomized clinical trial of drug-eluting stents ever conducted, and the only trial sufficiently powered to measure stent thrombosis, show low rates of blood clots occurring inside drug-eluting stents implanted in "real-world" patients. What makes this study important is the very large number of patients: over 8,700 at 196 centers in 36 countries across five continents. (Read more...)

August 27, 2012
Medtronic Study Confirms Long-Term Safety of Drug-Eluting Coronary Stents
Results of a landmark clinical trial, PROTECT, presented for the first time today at the 2012 European Society of Cardiology (ESC) Congress, confirm the long-term safety of drug-eluting stents in the treatment of coronary artery disease in real-world clinical practice. (Read more...)

July 18, 2012
Medtronic Begins Global Clinical Trial Evaluating CoreValve® System Implantation in Intermediate-Risk Patients
Medtronic, Inc. (NYSE: MDT) today announced the first patient enrollment in a global, multicenter, randomized clinical trial comparing the Medtronic CoreValve® System with surgical aortic valve replacement in patients with severe aortic stenosis who are at intermediate risk to undergo open-heart surgery. The trial, called Medtronic CoreValve Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) Trial, will evaluate the potential for the minimally-invasive CoreValve System to be considered for less-sick patients who typically are treated with open-heart surgical aortic valve replacement (SAVR) today. (Read more...)

June 21, 2012
Medtronic Stent Graft Chosen by U.S. FDA for Innovative Program
The U.S. Food and Drug Administration (FDA) recently selected a stent graft being developed by Medtronic, Inc. (NYSE: MDT) for an early feasibility pilot program that allows for "early clinical evaluation to provide proof of principle and initial clinical safety data." (Read more...)

June 13, 2012
Statement on Today's FDA Transcatheter Heart Valve Hearings from American College of Cardiology and Society of Thoracic Surgeons
ACC President William Zoghbi, MD, FACC stated, "The use of registries in post-approval surveillance is valuable for tracking long-term outcomes and quality of life issues for patients. The TVT Registry, sponsored by the ACC and The Society of Thoracic Surgeons, continues to grow and to become an important tool for capturing and reporting patient demographics, procedure details, and facility and physician information. (Read more...)

June 10, 2012
Can Using IVUS (Intravascular Ultrasound) Prevent Stent Thrombosis?
Commentary from the Editor's Blog: A recent paper, published online before print in SCAI's journal, Catheterization and Cardiovascular Interventions, yet again adds to the evidence that intravascular ultrasound (IVUS) imaging during PCI can improve stent placement and expansion in a way that may prevent stent thrombosis (ST). (Read more...)

June 7, 2012
Lasorda Released from Hospital
Tommy Lasorda, who at the age of 84 had a heart attack and was treated with angioplasty and a sten, was released today from the hospital, less than 72 hours later. (Read more...)

June 6, 2012
What We Can Learn from Tommy Lasorda's "Mild" Heart Attack
Commentary from the Editor's Blog: Before he was Hall of Fame manager of the Los Angeles Dodgers, Tommy Lasorda was a scout and coach for the team. And part of his duties was to teach the rookies. So, in that tradition, there is a lesson in Tommy's latest health scare: if you think you may be having a heart attack, get to the hospital ASAP, preferably a hospital that performs emergency angioplasty. (Read more...)

June 6, 2012
Medtronic Launches Endurant® II AAA Stent Graft System in U.S.
Medtronic, Inc. (NYSE: MDT) announced today the U.S. launch of the Endurant® II AAA Stent Graft System, which recently received approval from the U.S. Food and Drug Administration (FDA) for the minimally invasive treatment of abdominal aortic aneurysms through endovascular repair (EVAR), an alternative to major surgery. (Read more...)

June 4, 2012
Boston Scientific Receives FDA Approval for 32 MM and 38 MM Lengths for PROMUS Element™ Plus Platinum Chromium Stent System
The PROMUS Element Plus Stent System is now available in a matrix of 94 sizes, ranging in diameter from 2.25 mm to 4.00 mm and lengths of 8 mm to 38 mm on both Monorail® and Over-the-Wire catheter platforms. (Read more...)

May 31, 2012
Analysis of Medtronic's Resolute Stent Shows Safety with Only Six Months of Antiplatelet Therapy
An analysis of the RESOLUTE US trial, with additional data from the pooled Resolute global clinical program, concluded that there was no sign that patients who stopped taking clopidogrel/ticlopidine and aspirin at six months had any increased risk of clinical safety events or stent thrombosis, when compared to patients who continued on the drugs for 12 and 24 months. (Read more...)

May 30, 2012
Patient Alert: How to Get the Best Price on New Generic Plavix
A survey by Angioplasty.Org shows prices range from 35¢ to $6 per pill. Are you paying too much for your antiplatelet medication? (Read more...)

May 25, 2012
Medtronic Resolute® Stent Shows Strong Performance in Heart Disease Patients With and Without Diabetes
According to study results to be featured in Sunday's late-breaking clinical trials session at the American Association of Clinical Endocrinologists (AACE) 21st Annual Scientific and Clinical Congress in Philadelphia, the Resolute® drug-eluting stent (DES) from Medtronic, Inc. (NYSE: MDT) yields strong performance in coronary artery disease (CAD) patients both with and without diabetes through two years of follow-up. (Read more...)

May 16, 2012
Medtronic IN.PACT Drug-Eluting Balloon Studies Show Significant Benefit of Novel Medical Device in Treating Narrowed Arteries
Adding to the growing body of evidence on a novel interventional cardiovascular device, physicians presented today at EuroPCR 2012 the results of two multicenter, randomized controlled trials, the BELLO and PACIFIER studies, each one showing statistically significant advantages of using an IN.PACT drug-eluting balloon from Medtronic, Inc. (NYSE: MDT) over corresponding conventional treatments for coronary and peripheral artery disease: uncoated balloons and drug-eluting stents. (Read more...)

May 15, 2012
Abbott's XIENCE PRIME™ and XIENCE V® Drug Eluting Stents Receive Indication in Europe for Minimum 3-Month Duration of Dual Anti-Platelet Therapy
Abbott (NYSE: ABT) today announced that the XIENCE PRIME™ and the XIENCE V® Everolimus Eluting Coronary Stent Systems have received CE Mark in Europe for the use of dual anti-platelet therapy (DAPT) for at least three months after stent implantation in patients with coronary artery disease. This is the shortest duration of DAPT for any major drug eluting stent (DES) in Europe. (Read more...)

May 15, 2012
FAME II: Should Fractional Flow Reserve (FFR) Be Mandatory?
Commentary from the Editor's Blog: Earlier today, the opening day of EuroPCR, Dr. Bernard De Bruyne presented preliminary results from the FAME II trial which tested the diagnostic power of Fractional Flow Reserve to guide PCI (stenting) of the coronary arteries. He concluded in his remarks: "Whether a patient needs PCI, or is better off with medical treatment, the data thus far reveal that treatments based on FFR guidance provide superior outcomes." (Read more...)

May 15, 2012
Medtronic Nets New Indications for Resolute Integrity Drug-Eluting Stent in Europe
The Resolute Integrity DES is now explicitly indicated in countries outside the United States that accept the CE mark for the following patient and lesion types: acute coronary syndromes, acute myocardial infarction, unstable angina; diabetes mellitus; bifurcations; multi-vessel disease; total occlusions and chronic total occlusions; and in-stent restenosis. All but the indications for diabetes and multi-vessel disease are new. (Read more...)

May 15, 2012
FAME II Trial Demonstrates FFR-Guided PCI Superior to Medical Treatment in Preliminary Findings
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that data from the FAME II trial demonstrated a significant difference in the need for urgent revascularization when Fractional Flow Reserve (FFR)-guided assessment was used to direct treatment in patients with stable coronary artery disease. These highly statistically significant results validate the profound role that FFR-guided therapy has in improving patient outcomes. (Read more...)

May 9, 2012
Risk Score Devised for Carotid Stents
Dr. Beau Hawkins, an interventional cardiology fellow at Massachusetts General Hospital in Boston, has devised a risk assessment tool, using patient outcomes and characteristics found in the National Cardiovascular Data Registry (NCDR) CARE Registry. This tool can be utilized in the office without the need for a complex and expensive invasive angiographic test. (Read more...)

May 8, 2012
Medtronic Expands Availability of Valiant® Captivia® Stent Graft in Major Global Markets
Increasing patient access to endovascular repair of aortic aneurysms worldwide, Medtronic, Inc. (NYSE: MDT) is expanding availability of the Valiant® Captivia® Thoracic Stent Graft System in several countries, including China, Japan and the United States. (Read more...)

May 5, 2012
Attention Stent Patients: Plavix Going Generic!
On May 17, less than two weeks from now, U.S. patent protection will end for Plavix (clopidogrel), the best-selling antiplatelet drug made by Bristol-Myers Squibb / Sanofi-Aventis. This is certainly good news for stent patients throughout the U.S. (clopidogrel has already gone generic in Canada and other countries). (Read more...)

April 17, 2012
Medtronic Announces Global Drug-Eluting Balloon (DEB) Study
Medtronic, Inc. (NYSE: MDT) announced its plans for the imminent start of the IN.PACT Global SFA clinical study, an international research program to evaluate the treatment of peripheral artery disease using the company's IN.PACT Admiral™ drug-eluting balloon. The purpose of this prospective, multicenter study is to collect and assess safety and efficacy data on the IN.PACT balloon for the treatment of atherosclerotic disease in the superficial femoral (SFA) and/or popliteal arteries. This study calls for enrolling up to 1,500 "real world" patients at up to 80 sites in numerous countries and will allow lesions of any length. (Read more...)

April 13, 2012
Medtronic Initiates Landmark U.S. Drug-Eluting Balloon (DEB) Study
Medtronic, Inc. (NYSE: MDT) announced today the start of the Medtronic IN.PACT SFA II study, the company's first U.S. clinical trial for its line of IN.PACT drug-eluting balloons. The first patients in this landmark study were treated this week by Dr. Ash Jain at Washington Hospital in Fremont, Calif., and Dr. Brian Bigelow at St. Vincent Hospital in Indianapolis; Dr. Monica Hunter at Christ Hospital in Cincinnati is planning to treat a patient in the study as early as next week. (Read more...)

March 24, 2012
Medtronic Resolute® Drug-Eluting Stent Delivers Durable Clinical Outcomes Through Two Years in Major Studies
According to new clinical data presented today at ACC.12 –– the 61st Annual Scientific Session and Expo of the American College of Cardiology (ACC) –– the Resolute drug-eluting stent (DES) from Medtronic, Inc. (NYSE: MDT) maintains a powerful and persistent treatment effect for a wide variety of patients with coronary artery disease, including those with diabetes mellitus, through two years of follow-up. (Read more...)

March 7, 2012
Remarkable Stent Procedure
Commentary from the Editor's Blog: Every once in a while, the "complaint department" aspect of our Patients' Forum is overshadowed by a positive report of how angioplasty literally saved someone's life or, at least, their heart muscle. Here is a post to our Forum Topic: "Angioplasty Success Stories." (Read more...)

March 4, 2012
Stent-Trek: The Next Generation
Commentary from the Editor's Blog: The story here is no longer so much about behemoth entities and dark lords battling each other for control of the universe (not that this aspect has gone away) but a story of refinement, sleeker technology and, yes, much more Data! And this past couple of weeks has seen some important developments in the next generation of stents that are positive for both patients and physicians. (Read more...)

March 1, 2012
FDA Approves First Drug-Eluting Stent for Use During Heart Attacks
A new generation of drug-eluting stents has emerged in the past couple of years, with thinner struts, thinner coatings and more biocompatible polymers. However, treating a patient who is having a heart attack has still been an "off label" use for drug-eluting stents. Until last week.... (Read more...)

February 28, 2012
Stents vs. Pills -- Summer Re-run in February
Commentary from the Editor's Blog: A meta-analysis, titled, "Initial Coronary Stent Implantation With Medical Therapy vs Medical Therapy Alone for Stable Coronary Artery Disease", appeared in yesterday's Archives of Internal Medicine (AIM), a journal that has historically worn its anti-PCI bias on its sleeve. In my opinion, there are several significant issues/flaws in this publication that need to be addressed and here are five of them. (Read more...)

February 27, 2012
New Drug-Eluting Stent Okayed for Diabetics
What was an "off label" use of drug-eluting stents only a week ago is now "on label" -- the FDA has approved Medtronic's new zotarolimus-eluting stent, the Resolute Integrity, specifically for use in diabetic patients, a population that historically has seen less than optimal outcomes for percutaneous coronary interventional procedures (PCI). (Read more...)

February 17, 2012
Medtronic Resolute Integrity™ Drug-Eluting Stent Obtains FDA Approval for Treating Coronary Artery Disease
Medtronic Inc. (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) approval of the Resolute Integrity™ Drug-Eluting Stent (DES) for the treatment of coronary artery disease (CAD) including a specific indication for treatment of patients with diabetes. The new heart device's FDA approval stems from the results of a global series of studies involving the Resolute DES, which showed consistently powerful clinical performance across a broad spectrum of patients –– including those with diabetes, a common contributor to coronary artery disease that complicates treatment. (Read more...)

February 15, 2012
TWENTE Published: Medtronic Resolute Heart Stent Matches Abbott's Xience
The TWENTE clinical trial, comparing two 2nd-generation drug-eluting stents, Medtronic's Resolute zotarolimus-eluting stent and Abbott's Xience V everolimus-eluting stent, was published today as an expedited paper in the Journal of the American College of Cardiology. At one-year, the two stents had similar clinical outcomes in 1,391 "real-world" patients. (Read more...)

February 13, 2012
Medtronic Launches Two New Clinical Programs to Evaluate the Use of Symplicity™ Renal Denervation System Across Multiple Conditions
Medtronic, Inc. (NYSE: MDT) announced today the start of two clinical initiatives evaluating the broader, real-world clinical use of the company's Symplicity™ renal denervation system across multiple conditions: the Global SYMPLICITY Patient Registry, which will evaluate the real-world, long-term impact of renal denervation in more than 5,000 patients; and SYMPLICITY-HF, the first clinical trial to examine renal denervation in patients with chronic heart failure and renal impairment. (Read more...)

February 8, 2012
Medtronic Stent for Narrowed Leg Arteries: 90% Freedom from Reinterventions at One Year
Today Medtronic announced the one-year results of the Complete SE SFA study, a prospective, multicenter, single-arm trial designed to evaluate the safety and efficacy of the Complete SE vascular stent system in the treatment of de novo and/or restenotic lesions or occlusions in the superficial femoral artery (SFA). The bottom line results were a primary patency rate of 73.1 percent, a major adverse event rate of 11.0 percent and a target lesion revascularization (TLR) rate of 9.4 percent. (Read more...)

January 27, 2012
Stent Pioneer Gary Roubin Leaving Lenox Hill
Interventional cardiology pioneer, Dr. Gary Roubin, is leaving Lenox Hill Heart & Vascular Institute in New York, where he has served as chair of Interventional Cardiac & Vascular Services for almost a decade. (Read more...)

January 24, 2012
Medtronic Completes Enrollment of Extreme Risk Patient Group in CoreValve® U.S. Pivotal Trial
Medtronic, Inc. (NYSE: MDT) today announced it has completed patient enrollment in the extreme risk study in its CoreValve U.S. Pivotal Trial. The company also received approval from the U.S. Food and Drug Administration (FDA) for an extended investigation (under the FDA's Continued Access Policy) to continue enrolling extreme risk patients under a Continued Access Study protocol. In the Trial's second study evaluating high risk patients for aortic valve surgery, enrollment completion is anticipated later this year. (Read more...)

January 21, 2012
FAME II Is Not the "Anti-COURAGE": Stents and Angioplasty in the Spotlight
There's been much talk this week, given the news that the FAME II clinical trial ended enrollment early, due to ethical concerns that were generated by the fact that patients randomized to Optimal Medical Therapy (OMT) alone were returning to the hospital in significant numbers for "urgent revascularization." So is this a reversal of the COURAGE trial results? Not according to the principal investigators of both the FAME II trial AND the COURAGE trial, whom I have spoken with in the past 48 hours. (Read more...)

January 18, 2012
Does FAME II Trump COURAGE? FFR: Key to Stents and Angioplasty
Commentary from the Editor's Blog: St. Jude Medical (NYSE:STJ) announced that it is stopping enrollment in its FAME II trial after only 2/3 of the planned patients were included. Why? Because the interim data so clearly favor the use of Fractional Flow Reserve (FFR) to guide stenting (PCI) in stable angina patients that the independent Data Safety Monitoring Board (DSMB) for the trial has concluded that it would be unethical to continue to randomize patients to optimal medical therapy (OMT) alone. Wait a minute! Did they say that using optimal medical therapy alone was unethical for the treatment of stable angina patients? That's pretty big news! (Read more...)

January 18, 2012
Independent Data Safety Monitoring Board Recommends St. Jude Medical's FAME II Clinical Trial Stop Enrollment Following Positive Interim Analysis
St. Jude Medical, Inc. (NYSE:STJ) announced today that an interim analysis of the FAME II trial has found a highly statistically significant reduction in the need for hospital readmission and urgent revascularization when Fractional Flow Reserve (FFR)-guided assessment was used to direct treatment in patients with coronary artery disease. As a result of the positive interim analysis, the FAME II independent Data Safety Monitoring Board (DSMB) has recommended investigators stop patient enrollment in this trial as the DSMB considers it unethical to continue to randomize patients to optimal medical therapy (OMT) alone. (Read more...)

January 17, 2012
AAA Stent Graft Revisited
Commentary from the Editor's Blog: I revisit a patient who received an AAA stent graft a year-and-a-half ago and continues to stay physically active -- competing in Ironman races! (Read more...)

January 17, 2012
Medtronic Endurant® II AAA Stent Graft System Launches Internationally With CE Mark
Medtronic Inc. (NYSE: MDT) today announced the CE (Conformité Européenne) mark and international launch of the Endurant® II AAA Stent Graft System, which meaningfully expands the options physicians outside the United States have to treat patients with abdominal aortic aneurysms through a minimally invasive technique called endovascular aortic repair (EVAR). (Read more...)

January 9, 2012
New Drug-Eluting Stents: Lower Mortality and Less Restenosis Than First Gen DES or Bare Metal Stents
A new report in the European Heart Journal, analyzing 94,384 stent placements, finds that the new generation of drug-eluting stents (Medtronic's Endeavor Resolute, Abbott's XienceV and Xience Prime, and Boston Scientific's Promus and Promus Element) are associated with lower rates of restenosis, stent thrombosis and mortality than either the first generation drug-eluting stents or bare-metal stents. (Read more...)

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