FDA Approves First Absorbable Stent For Treatment of CAD
The U.S. Food and Drug Administration (FDA) on July 5 approved the Absorb GT1 Bioresorbable Vascular Scaffold System (BVS) for the treatment of coronary artery disease (CAD). The Absorb GT1 BVS is the first fully absorbable stent for patients with coronary heart disease and is an alternative treatment to permanent metal stent implants. The stent is made of biodegradable polymer called poly(L-lactide). According to the FDA, "after absorption, there are only four very small platinum markers embedded in the walls of the artery, which help cardiologists identify where the Absorb GT1 BVS was originally placed."
The approval of the stent is based on the results of the ABSORB clinical trials, which examined the efficacy and non-inferiority of the Absorb GT1 BVS compared to metal stents. An advisory panel to the FDA recommended approval of the stent system in March 2016.
Read the FDA's announcement.
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