–Shifting the burden of proof from preapproval to postapproval. The new FDA commissioner Scott Gottlieb is quietly and persistently revamping the FDA to make it easier for drug and device companies to get their products on the market. The news, which is being welcomed by industry, also almost certainly means that more people will be…
Abbott Pulls Troubled Absorb Stent From European Market
April 6, 2017 by Leave a Comment
(Updated) Abbott Laboratories has sent a letter to European physicians informing them that the Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS “will only be available for use in clinical registry setting at select sites/institutions.” The company’s action comes in response to an avalanche of bad news for the controversial device. Last fall 3-year results from…
More Bad News For The Once Promising Bioresorbable Stent
March 31, 2017 by Leave a Comment
(Updated) –Problems for the Absorb BVS stent just won’t disappear Bad news for the Absorb BVS stent continues to accumulate, though defenders of the device keep looking for a silver lining. When it was approved in the US last summer the novel device appeared to have a bright future, with many prominent interventional cardiologists predicting…
The Impact Of ABSORB II: Down The Slippery Slope
November 2, 2016 by 2 Comments
When it was approved earlier this year in July the Absorb (Abbott) bioresorbable stent provoked a fair amount of discussion about the “slippery slope of noninferiority.” Although the stent met the FDA criteria for approval, the available trial results went in the wrong direction and there was a particularly concerning warning sign of a higher…
Reality Check On The ‘Noninferior’ Abbott Bioresorbable Stent
July 12, 2016 by Leave a Comment
–The slippery slope of noninferiority. Last week the big news in interventional cardiology was the approval of Abbott’s bioresorbable stent, Absorb. There’s no doubt that this represents a remarkable technical achievement, propping open a clogged artery and then gradually disappearing. There are all sorts of theoretical reasons why this might represent an important advance over traditional stents that…
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