dilluns, 31 de juliol del 2017

Boston Scientific to end Renuvia bioresorbable coronary stent program

Boston Scientific

Boston Scientific (NYSE:BSX) is looking to terminate its Renuvia bioresorbable coronary stent program, according to a Minneapolis Star Tribune report.

The move comes after new clinical studies of Abbott‘s (NYSE:ABT) Absorb bioresorbable stent indicated that use of the device resulted in a higher risk of serious adverse events compared to metal stents.

Marlborough, Mass.-based Boston Scientific said that while the bioabsorbable plastic stents do “show promise”, the company will be focusing on different areas of development.

“We’ve just decided strategically that there are bigger problems to deal with, and more socially impactful problems, like stroke, like heart failure, that need our attention. And it is better to invest in those things that will have bigger impacts than to try and overcome the technical challenges [of bioresorbable stents] in the short term,” global chief medical officer Dr. Ian Meredith told the Star Tribune.

So far, Abbott is the only medical device company in the US to have won approval for a completely bioresorbable stent with its Absorb GTI BVS device.

While the market for such stents was expected to reach the billions by 2021, data on heightened adverse events associated with the Absorb stent have damaged those prospects. A study released this month backed up earlier data, released in March, which showed increased rates of adverse events at 2-years with the Absorb when compared against metallic drug-eluting stents.

“The current findings … provide evidence beyond any reasonable doubt that Absorb BVS is inferior to new-generation [metal stents made by Abbott] on both efficacy and safety throughout 2 years. It cannot be anticipated that the potential long-term benefits of the current version of Absorb BVS will offset the excess in adverse events reported during the first 2 years,” wrote authors of a Lancet comment piece published earlier this month, according to the Star Tribune.

Data from the recent study, also published in Lancet this month, reported that while mortality rates were similar between Absorb and metal-stent patients, those treated with the Absorb showed statistically significantly higher rates of blood vessel blockage and subsequent heart attacks.

Boston Scientific is still set to release 6-month results from a trial of its Renuvia at the Transcatheter Cardiovascular Therapeutics meeting later this year, and while data looks solid, the company is still planning on cutting support for the program, according to the report.

“You have to ask the question, do we actually put the effort into studying this in much more complex patients, many of whom are at higher risk of events anyway, against a background of literature from all over the world showing consistently that this strategy is associated with worse outcomes? We think it doesn’t make sense to do this, and … we should put our energies into treating bigger problems affecting the human race in the 21st century,” Meredith told the Star Tribune.

The post Boston Scientific to end Renuvia bioresorbable coronary stent program appeared first on MassDevice.



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