April 6, 2017 · 11:12 am
Last night news began circulating on Twitter that Abbott’s Absorb BVS (Bioresorbable Vascular Scaffold) was being withdrawn from the European market. This information was prompted by several physicians posting on Twitter a March 31 “Urgent Field Safety Notice/Physician Advisory” letter from Abbott addressed to “Valued Abbott Vascular Customer.”
A number of news sources, including this one, posted articles and tweets to the effect that the Absorb was being taken off the commercial markets and, as the letter stated, “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.”
This morning Abbott reacted to this initial flurry of reports that they had “pulled the Absorb” with some clarification: specifically that the Absorb is NOT being pulled from the market and still retains the CE Mark. An Abbott spokesperson told Angioplasty.Org, “Absorb will continue to be commercially available in Europe through the registries.”
But the relationship, as they say on Facebook, is complicated.
Continue reading →
August 30, 2016 · 9:29 pm
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 of the Clinic for Heart Disease, St. Olav’s University Hospital in Trondheim, Norway. 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! Continue reading →
Filed under Antiplatelet Medications, Back to the Future, Bare Metal Stents, Clinical Trials / Studies, Cost Effectiveness, Diabetes, Drug-Eluting Stents, Europe, Global Trends, Media Coverage, Meetings & Conferences, Patient Experience, Patients, Stent, Stent Thrombosis
November 16, 2014 · 2:33 pm
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?
This is a question asked back in 2006, during a special two-day FDA hearing, convened to discuss all known issues with drug-eluting stents and prompted by the “ESC firestorm” over the problems of increased incidence of late stent thrombosis in drug-eluting stents. (See “Problems Resurface with Drug-Eluting Stents” – September 9, 2006.) Continue reading →
February 18, 2013 · 4:44 pm
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. (See our Patient Alert: How to Get the Best Price on New Generic Plavix.) But are the generic versions of clopidogrel really the same? Continue reading →
October 30, 2012 · 8:54 pm
We just posted a report on the XIMA Trial which studied stents in octogenarians. The trial compared drug-eluting with bare-metal stents and the results are very interesting: while the trial didn’t find a difference in these two types of stents for the pre-specified composite endpoint of death, heart attack, revascularization, stroke and major bleeding…it did find significantly lower incidence of revascularization and heart attack in those patients who received the drug-eluting Xience stent.
But the real take-away from the XIMA Trial is that stenting and angioplasty in the elderly is safe and effective. Mortality from cardiac causes in this trial was 4% at one year, no matter which stent was used. Continue reading →
May 5, 2012 · 10:03 pm
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. In 2010, worldwide sales of Plavix topped $6 billion (yes…billion!). For a typical stent patient, one 75mg tablet of Plavix a day costs more than $210 a month. Those with drug-eluting stents (80% or more of patients) must take Plavix for a year minimum. So the required medication actually can cost more than the stent itself. Continue reading →
March 4, 2012 · 1:30 pm
Yeah. I went there. Since everyone from Motley Fool to MassDevice to the Wall Street Journal feels the need to use “Stent Wars” (a pun that I originated on this website a decade ago) I’ve decided to go all TV. Actually, “The Next Generation” is also a more appropriate reference than the “Wars” moniker, because 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. Continue reading →