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July 25, 2019
Interview with Dr. Hirotoshi Watanabe on the STOPDAPT-2 Study
The STOPDAPT-2 study demonstrated that 1 month of DAPT followed by clopidogrel monotherapy, compared with 12 months of DAPT with aspirin and clopidogrel, resulted in a significantly lower rate of a composite of cardiovascular and bleeding events, meeting criteria for both noninferiority and superiority. Angioplasty.Org’s partner site, TCROSS NEWS, recently interviewed Dr. Watanabe, a principal author of the present study, regarding the background and important findings of the study.

February 26, 2019
FDA Approves Medtronic's Resolute Drug-Eluting Stent Platform for Treatment of Chronic Total Occlusions
Medtronic's Resolute Onyx Drug-Eluting Stent
The FDA today approved an expanded indication for Medtronic's family of Resolute zotarolimus-eluting coronary stents: use in the treatment of de novo chronic total occlusions (CTO). This approval includes all Resolute DES devices, including the Resolute Onyx™ and Resolute Integrity™ DES.

May 23, 2018
Newest Generation of Leading Heart Stent is Now Approved in the U.S. for People with Coronary Artery Disease
Xience Sierra Everolimus-Eluting Stent
Abbott (NYSE: ABT) today announced it received approval from the U.S. Food and Drug Administration (FDA) for XIENCE Sierra™, the newest generation of the company's gold-standard XIENCE everolimus-eluting coronary stent system. XIENCE stents are among the world's most-used and studied stents and have an exceptional safety record with low rates of complications. Design and technology advances in this generation of XIENCE include features specifically designed for the treatment of complex blockages that now account for up to 70 percent of cases.

February 26, 2018
Medtronic's Resolute Onyx Stent Now Available in Diameters from 2.0-5.0mm
Medtronic Resolute Onyx
Based primarily on the results of the RESOLUTE ONYX 2.0 mm Clinical Study, first presented at the EuroPCR meeting in May 2017, the U.S. FDA has approved Medtronic's Resolute Onyx™ 2.0mm zotarolimus-eluting stent, making it the smallest diameter DES on the market. The news, announced today by Medtronic plc (NYSE: MDT) means that the Resolute Onyx line is now available in the widest range of any coronary stent, from 2.0mm to 5.0mm

November 9, 2017
Interview with Yusuke Yoshikawa, MD
Dr. Yusuke Yoshikawa
Dr. Yoshikawa discusses his study, just published in Circulation, titled "Validating Utility of DAPT Score in a Large Pooled Cohort from Three Japanese PCI Studies," and he comments on how the Japanese population differs from western patients in terms of bleeding and ischemic event rates. (Posted in collaboration with TCROSS NEWS.)

October 31, 2017
Complex CTO-PCI: Japanese Approach
Dr. Etsuo Tsuchikane
This 20 minute video shows a complex CTO case, in which an RCA obstruction, complicated by a sharp bend and tortuous anatomy, was revascularized using both the antegrade and retrograde approaches, facilitated by IVUS and biplane angiographic imaging. The operator is Dr. Etsuo Tsuchikane; the case was broadcast live during the Japanese CTO Club course in June 2017. (Posted in collaboration with TCROSS NEWS.)

July 25, 2017
Clinical Trial to Study If 3-Months of DAPT is Safe After XIENCE Stent
Xience Everolimus-Eluting Stent
The study, called XIENCE Short DAPT, will evaluate if 3 months of DAPT is non-inferior to the current standard of 12 months after implantation with a XIENCE stent for patients who are at high risk of bleeding. The study will enroll approximately 2,000 patients at 100 sites in the U.S. and Asia.

June 19, 2017
Interview with Dr. Osamu Iida
Osamu Iida, MD
Dr. Iida was principal investigator for the PRIORITY registry, testing whether revascularization impacted survival at one-year for poor-risk-CLI patients. The study was published in the June 12 issue of JACC: Cardiovascular Interventions and looked at over 600 patients in 37 hospitals across Japan. (Posted in collaboration with TCROSS NEWS.)

May 1, 2017

Medtronic Launches Resolute Onyx™ Drug-Eluting Stent in United States Following FDA Approval Becoming First DES Available in 4.5 mm and 5 mm Sizes
Resolute Onyx™ Drug-Eluting Stent
Medtronic plc (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) approval and U.S. launch of the Resolute Onyx™ Drug-Eluting Stent (DES). The Resolute Onyx DES builds on the proven clinical performance and superior deliverability of the Resolute Integrity™ DES to further strengthen the gold standard safety and efficacy of DES technology.

April 6, 2017
History, Gruentzig, and Abbott’s Absorb “Dissolving Stent”
Gruentzig holding his PTCA balloon
There’s a lesson for the Absorb BVS in the history of interventional cardiology (an area of particular interest in this 40th anniversary of angioplasty year). Andreas Gruentzig, the inventor of coronary angioplasty had very specific requirements of physicians who were going to start using his balloons, and he also resisted the urge to over-publicize.

April 6, 2017
Status of the “Disappearing Stent” in Europe: It’s Complicated!
Abbott's Absorb BVS
An updated version of our article on Abbott’s Absorb BVS (Bioresorbable Vascular Scaffold) in the European markets. A letter, which just began circulating on Twitter last evening, was actually sent to Abbott’s customers in Europe a week ago. The letter states: “Effective May 31, 2017, the device will only be available in clinical register setting at select sites/institutions that will play a pivotal role in the monitoring of this technology until Summer 2018 at which time the situation will be reviewed.”

March 21, 2017
First U.S. Case Done with Tryton's Side Branch Stent
Tryton's Side Branch Stent
Earlier this month, the FDA approved Tryton Medical's Side Branch Stent and today, at New York-Presbyterian Hospital/Columbia University Medical Center in New York, the first case was performed by two of the leading interventional cardiologists in the U.S., Dr. Martin Leon and Dr. Ajay Kirtane

January 2, 2017
Abbott's Acquisition of St. Jude to Close This Week
St. Jude and Abbott logos
As of Wednesday, January 4, St. Jude Medical will no longer exist as a company; instead it will become part of Abbott, according to the press release below. This $25 billion deal is one of the largest recent mergers of medical device companies since Medtronic's 2015 acquisition of Covidien.

December 8, 2016
Interview with Dr. Masanori Yamamoto
Dr. Masanori Yamamoto
Dr. Masanori Yamamoto discusses the clinical and market impact in Japan of two new generation transcatheter aortic valves (TAVR): last week's approval of Medtronic's CoreValve Evolut R and Edwards' Sapien 3, which was approved earlier this year. (Posted in collaboration with TCROSS NEWS.)

December 5, 2016
Japan Announces Regulatory Process and Post Marketing Surveillance Policy for Abbott's Bioabsorbable Vascular Scaffolding
Abbott Absorb BVS and map of Japan
Last week Dr. Takashi Ouchi, a reviewer for the Office of Medical Devices III of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), announced the regulatory process and post marketing surveillance (PMS) policy that will be in effect for the Abbott Absorb bioabsorbable vascular scaffold (BVS). (This article was provided to Angioplasty.Org by its Japanese partner, TCROSS NEWS)

November 7, 2016
Abbott's Absorb™ Bioresorbable Stent Approved as the First Fully Dissolving Heart Stent in Japan
Abbott Absorb 'disappearing stent' approved in Japan
Abbott (NYSE: ABT) announced today that the Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the company's Absorb bioresorbable heart stent, making the first-of-its-kind medical device commercially available to treat people in Japan with coronary artery disease. Absorb is the only fully dissolving heart stent approved in Japan for the treatment of heart disease, one of the leading causes of death in Japan and worldwide.

October 31, 2016
First Clinical Data of Medtronic Drug-Filled Stent Show Positive Outcomes
Laser-drilled abluminal holes in Medtronic's Drug-Filled Stent
The RevElution trial enrolled 101 patients at 14 centers in three countries in two different cohorts measuring outcomes at nine months and 24 months. In the first 50 patients included in the nine-month primary endpoint cohort, the DFS had in-stent late lumen loss of 0.26mm, which was non-inferior to the historical control (p<0.001). In addition, the DFS demonstrated low rates of target lesion failure (2.1%) and zero stent thrombosis at nine months.

October 30, 2016
Independent Study Finds Biodegradable Polymer Stents Provide No Clinical Benefit Over Resolute Integrity™ DES
Professor Clemens von Birgelen
In the BIO-RESORT study, the primary composite endpoint of target vessel failure at one-year showed no statistically significant difference in outcomes for the Resolute Integrity DP-DES treated group (N=1173) at 5.4% compared to 4.7% with the Synergy BP-DES (N=1172) arm and 4.7% with the Orsiro (N=1169) BP-DES am (difference of 0.7%; p=0.45 for Synergy and p=0.46 for Orsiro). The one year outcomes also found no statistically significant difference in stent thrombosis between Resolute Integrity and the BP-DES groups (difference of 0.1%; p=0.77).

August 30, 2016
NORSTENT: Drug-Eluting Stents – Doing What They’re Supposed To
various stents
At this week’s annual European Society of Cardiology Congress in Rome, an important randomized clinical trial on stents was presented by Professor Kaare H. Bønaa, MD, PhD. Called NORSTENT, short for the “Norwegian Coronary Stent Trial,” this was the largest stent trial ever conducted, with 9,013 patients followed for six years. That’s serious!

July 24, 2016
Will Abbott's Absorb Bioresorbable Vascular Scaffold Revolutionize Treatment of Coronary Artery Disease?
Absorb BVS with question mark
In Part One of this feature, we reported on the various positives and negatives of the BVS, as presented to the FDA panel that recommended approval. Now that this device has been approved by the FDA, we discuss in Part Two the Absorb's potential impact in the United States with three leading interventional cardiologists, Drs. Ajay Kirtane, James Blankenship, and Daniel Simon.

July 14, 2016
Health Canada Approves Abbott's Absorb™ Bioresorbable Stent, the First Fully Dissolving Heart Stent
photo of the Absorb Bioresorbable Vascular Scaffold (BVS)
Abbott (NYSE: ABT) announced today that Health Canada has approved the company's Absorb bioresorbable heart stent, making the first-of-its-kind medical device commercially available to treat people in Canada with coronary artery disease. Abbott's Absorb heart stent is a first-of-its-kind medical device that is made of a naturally dissolving material. After opening up a clogged heart artery, Absorb completely dissolves in about three years.

July 5, 2016
FDA Approves Abbott's Absorb™ Bioresorbable Stent, The Only Fully Dissolving Heart Stent
photo of the Absorb Bioresorbable Vascular Scaffold (BVS)
Abbott announced today that the U.S. Food and Drug Administration has approved the company's Absorb bioresorbable heart stent, making the first-of-its-kind medical device commercially available to treat people with coronary artery disease in the United States. Absorb disappears completely[1] in approximately three years, after it has done its job of keeping a clogged artery open and promoting healing of the treated artery segment.

March 21, 2016
Part One: FDA Panel Recommends Abbott's Absorb Bioresorbable Vascular Scaffold for Approval
This is the first installment of a two part feature regarding current thinking about the Bioresorbable Vascular Scaffold. Part One discusses the history and some general background issues surrounding the device; Part Two (to be posted at a later date) consists of comments from leading interventional cardiologists about the current and future implications, predictions, critiques, and recommendations for the utilization of BVS.

March 15, 2016
Abbott's Absorb™, the First Fully Dissolving Heart Stent, Earns Positive Review by FDA Advisory Committee
Artist rendition of Abbott's Absorb BVS
Abbott (NYSE: ABT) announced today that an independent panel of experts convened by the U.S. Food and Drug Administration (FDA) voted 9 to 0, with one abstention, that the benefits of Abbott's Absorb fully bioresorbable drug eluting coronary stent outweigh the risks.

February 22, 2016
CE Mark for Boston Scientific's Eluvia Peripheral Stent
Eluvia™ Drug-Eluting Vascular Stent
Boston Scientific (NYSE: BSX) announced this morning that its Eluvia™ Drug-Eluting Vascular Stent has received the CE Mark for use in treating peripheral artery disease in the superficial femoral and proximal popliteal arteries. The company states that the Eluvia is the first polymer-based DES approved in Europe for use in the peripheral arteries.

January 24, 2016
Svelte Launches Its Slender IDS Stent-on-a-Wire System in Europe
Svelte SLENDER stent (R) vs. standard DES (L)
New Jersey-based Svelte Medical Systems, Inc. announced this week the launch of its novel SLENDER IDS stent-on-a-wire in Europe and other countries that accept the CE Mark. Svelte is planning to submit a PMA application to the US FDA this year. The SLENDER IDS gained the CE Mark last month and the company is now making the product available to select accounts in Europe that specialize in the transradial approach.

January 21, 2016
Clinical Trial of Novel Infusion Device for Below the Knee Angioplasty Begins in Germany
rof. Dr. Dierk Scheinert
University Hospital of Leipzig
Today Mercator MedSystems announced the start of a clinical trial for its Bullfrog® Micro-Infusion Device which will treat the blockage post-angioplasty (or atherectomy) with a dose of dexamethasone, an anti-inflammatory steroid, in the hopes of preventing the build-up of scar tissue which leads to restenosis of the vessel. Prof. Dr. Dierk Scheinert commented, "We are very excited with the start of this important clinical trial. There remains a real need for enhancements in therapy for treating patients with critical limb ischemia (CLI). We aim to show with this trial that the therapy can improve the outcomes in this desperate condition."

December 15, 2015
Svelte's Stent-on-a-Wire Gains CE Mark
Svelte stent (R) vs. standard DES (L)
Svelte Medical Inc., a relatively small device manufacturer based in New Jersey today achieved a milestone: the CE Mark approval that will allow the company to commercialize its novel stent-on-a-wire in Europe and other countries that accept the CE Mark. Svelte hopes to submit a PMA application to the FDA in 2016. The approval was based mainly on the results of the DIRECT II study of 189 patients which showed no stent thrombosis at four years and efficacy, measured by target vessel failure and in-stent late loss, at least as good as the standard drug-eluting stents currently on the market.

October 13, 2015
Medtronic's Drug-Filled Stent: First Data
Medtronic's Drug-Filled Stent
Called a DFS ("drug-filled stent") it is both a drug-eluting stent AND a bare metal stent, utilizing the same stent construction that Medtronic currently uses in its Resolute Integrity and Onyx stents. The stent is fashioned from a single strand of metal that can have several "inner cores." In the DFS, the drug is contained in a reservoir, inside the stent, and slowly eluted through small laser-drilled holes in the metal outer core.

October 12, 2015
Abbott Announces Positive Clinical Results of Absorb™, the Naturally Dissolving Heart Stent
Artist rendition of Abbott's Absorb BVS
The results, which showed that ABSORB III met its primary endpoint and will be used to support regulatory approval of Absorb in the U.S., were featured today during a late-breaking session at the 27th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation. In addition, the study results were published simultaneously in The New England Journal of Medicine.

October 5, 2015
Boston Scientific Receives FDA Approval For SYNERGY™ Bioabsorbable Polymer Drug-Eluting Stent System
SYNERGY™ Bioabsorbable Polymer DES
Boston Scientific (NYSE: BSX) has received FDA approval for the SYNERGY™ Bioabsorbable Polymer Drug-Eluting Stent System (BP-DES) for the treatment of coronary artery disease. Boston Scientific will commence commercialization of the first and only BP-DES in the U.S.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

March 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).

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