Abbott Laboratories’s bioresorbable Absorb stent.
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.
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