Category Archives: Business & Industry

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Last night news began circulating on Twitter that Abbott’s Absorb BVS (Bioresorbable Vascular Scaffold) was being withdrawn from the European market.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

Radial Revolution in the U.S.

Seton Medical Center

Seton Medical Center

It was over a dozen years ago that I saw my first transradial PCI. I had booked a photo shoot with Dr. Felix Millhouse at Seton Medical Center in Daly City, California, to get some shots for our web site. I did one case and was told that Dr. Millhouse was doing an urgent PCI in cath lab #2. So I went over to shoot it, but by the time I got to the lab, I was too late. I saw a man with his arm extended off the table. And Dr. Millhouse was removing his gloves. “Sorry,” he said. “We’re all done.” Continue reading

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Filed under Business & Industry, Global Trends, History, Transradial Approach

Philips Buys Volcano: It’s About Money, Technology, and History

  Rumors and theories about an acquisition of Volcano Corporation (NASDAQ: VOLC) had been circulating for quite some time: months, years even. The company seemed an obvious choice: it has an advanced intravascular ultrasound (IVUS) technology that leads the market, with Boston Scientific coming in second; it has a fractional flow reserve (FFR) wire that splits the market with St. Jude Medical; and recently Volcano gained FDA approval for its Instant Wave-Free Ratio (iFR) physiologic measurement product, a faster, cheaper potential alternative to FFR. Continue reading

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Filed under ACC, Angiograms, Back to the Future, Business & Industry, Cardiac CT, Cost Effectiveness, FFR, Global Trends, History, Imaging, Intravascular Guidance, IVUS, OCT, Video

Fractional Flow Reserve: Measuring Pressures in the Marketplace

Dr. Andreas Gruentzig

I don’t know how anyone can do these procedures without measuring pressures!

That’s what Andreas Gruentzig, the father of coronary angioplasty, said to me back in 1985. He knew that looking at the angiogram alone was not sufficient for judging the blockage in an artery. Integral to the design of his technological breakthrough, the double-lumen angioplasty balloon, was a feature which allowed him to measure the blood pressure at either end of the arterial blockage. At the start of the procedure, he could quantify how significant the blockage was; when he was done inflating the balloon, he could see the benefit of the dilatation. The post-angiogram might look good, but the pressures sometimes signaled that blood flow through the area was not. So, inflate again. And maybe again. OK, pressure now looks good, we’re done! Pretty simple. Not brain surgery. Continue reading

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Filed under Business & Industry, Cost Effectiveness, FAME I / FAME II, FFR, History, Stent