The Impact Of ABSORB II: Down The Slippery Slope

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…

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Report Finds Problems With FDA Mandated Postapproval Device Studies

As a condition of approval FDA often requires manufacturers of medical devices to perform postapproval studies. Now a General Accounting Office (GAO) audit [PDF] finds that, among other problems, many studies remain unfinished for a great many years. In addition, digging on its own into the FDA database of postapproval studies, The Gray Sheet, a device industry newsletter, focused…

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