Last month, the FDA approved Boston Scientific’s Promus Element Heart Stent, a tiny tubular device designed to open diseased arteries. Interestingly, the agency issued its approval of the device, even after receiving reports that the stent could potentially become deformed after it is implanted. The problem, officially known as longitudinal stent deformation, also occurs in [...]
Federal Regulators Require Warning on Boston Scientific’s Promus Element Heart Stent
December 19, 2011 By