Category Archives: Europe

Status of the “Disappearing Stent” in Europe: It’s Complicated!

Last night news began circulating on Twitter that Abbott’s Absorb BVS (Bioresorbable Vascular Scaffold) was being withdrawn from the European market.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.

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Filed under ACC, Antiplatelet Medications, Bioresorbable Stents/Scaffolds, Business & Industry, Clinical Trials / Studies, Europe, Stent, Stent Thrombosis

NORSTENT: Drug-Eluting Stents – Doing What They’re Supposed To

Coronary StentsAt 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

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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

InterZENtion: Transradial PCI as an Art

Transradial Coronary Interzentions by Dr. Ferdinand Kiemeneij

Transradial is one of the big buzzwords in interventional cardiology these days. In the United States practitioners recently have been discovering its advantages and have been learning how to perform it successfully. Utilization of transradial in the U.S. has jumped from 2% to almost 25% in less than a decade. In Europe, Japan, India, and China, transradial has been used for years and in most of those regions adoption runs from 50-90% of all catheter-based procedures. In Japan, and now in Europe, a specialized group of physicians has been pushing the limit of what can be done via the wrist artery, using “slender” procedures and equipment, with systems using 3, 4 and 5F sized catheters.

But the heart (pun intended) of this revolution in catheter-based access goes back over two decades to the pioneering work done by Dr. Ferdinand Kiemeneij, rightly dubbed “the father of transradial intervention.” You can read my interview with Dr. Kiemeneij here, but more importantly, you can and should and must read his brand-new hot-off-the-press book, “Transradial Coronary Interzentions,” available on Amazon. Continue reading

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Filed under Europe, France, Global Trends, Innovators, Japan, Medical Education, Patient Experience, Patients, Transradial Approach

New Treatment for Peripheral Artery Disease is Approved by the FDA

Dr. Charles Dotter in LIFE Magazine (1964)

Dr. Charles Dotter in LIFE Magazine (1964)

Who is that mad scientist in the 1964 issue of LIFE magazine? Oh, just the man who invented the concept of angioplasty; in fact he’s the man who actually coined the word “angioplasty!” And he’s the doctor who performed the first angioplasties in the leg, in order to save limbs from amputation without resorting to surgery.

Like many innovators, he had a crazy idea: to open blocked arteries from the inside out. No cutting, suturing, or stitching. Less trauma, lower morbidity, quicker recovery. His name was Charles Dotter and he was a radiologist in Portland, Oregon who, 51 years ago next week, performed an angioplasty on the blocked leg artery of an 82-year-old woman. Continue reading

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Filed under Back to the Future, Endovascular, Europe, FDA, History, Innovators, Peripheral Artery Disease (PAD), Video

For Transradial Angioplasty, “Slender and Lean” in the Netherlands

Slender Club Europe 2014: a new initiative of Slender Club Japan

Slender Club Europe 2014: a new initiative of Slender Club Japan

A criticism from some cardiologists of the transradial approach, in which diagnostic angiography and percutaneous interventions (angioplasty and stents) are performed through the radial artery in the wrist, has been that the radial artery is too small to permit successful navigation of the various sheaths, wires and catheters. Of course, it’s been more than two decades since Dr. Ferdinand Kiemeneij successfully opened a blocked coronary artery via the wrist and today, in many parts of the world, half of all procedures are done this way. Continue reading

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Filed under Europe, Global Trends, Innovators, Japan, Meetings & Conferences, Transradial Approach