FDA Warns on Abbott’s Bioresorbable Stent

The Absorb bioresorbable stent made by Abbott (NYSE:ABT) confers a higher risk of serious adverse events at 2 years compared with the company’s Xience drug-eluting stent, according to new data from a study that prompted the FDA to warn physicians on the risk.

But the picture is clouded by new guidelines indicating the proper blood vessel size and implantation technique; some 19% of patients in the 2008-subject trial were implanted in arteries that are now deemed too small for the device. Excluding those patients, the difference between the 2 stents was not statistically significant, according to the study.

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