Panel Recommends Approval for 2nd-Generation Drug-Eluting Stent

An FDA advisory panel voted 9–1 last week to recommend conditional approval for Abbott Laboratories’ Xience drug-eluting stent, a move that could spell trouble for Boston Scientific as analysts say a “successful launch of Abbott’s Xience in the U.S. will erode [Boston Scientific’s] Taxus franchise.”

The panel agreed that Abbott’s data show the everolimus-eluting stent is safe and effective for up to one year but voiced concerns about a lack of long-term safety data. The Circulatory System Devices Panel recommended a postmarket study of the stent to add to the long-term data, with conditions of the study to be determined by the FDA.

It also recommended the stent’s labeling regarding anti-platelet therapy be consistent with current guidelines and FDA recommendations for previously approved drug-eluting stents.

RBC Capital Markets analysts predicted the panel would recommend approval and said earlier this year that Abbott has “the best stent” after data indicated it is superior to Boston Scientific’s Taxus drug-eluting stent.