FDA warning about Abbott’s Absorb stent
Abbott Labs’s Absorb bioresorbable stent was one of the most promising medical devices that FDA approved last year. Now, there is a cloud over the stent’s potential after FDA this month issued a warning to physicians.
FDA issued the warning after new study data that showed that Absorb had a higher risk of serious adverse events at 2 years compared with the company’s Xience drug-eluting stent. Nearly a fifth of the 2,008 patients in the study, however, had stents implanted in arteries that are now considered too small for the device. Exclude the patients with the too-small arteries, and there was no statistical significance between Absorb and Xience in the study.