Johnson & Johnson/Boston put case for DES (drug-eluting stents) safety at FDA stent session:
This article was originally published in Clinica
Executive Summary
Day one of the FDA's two-day review of the safety of drug-eluting stents (DESs) closed yesterday with Boston Scientific and Johnson & Johnson telling the six-member circulatory system devices panel that their products are safe for a broad range of patients, despite findings and claims published this year of the risk of late stent restenosis (see Clinica No 1235, p 1). DESs are implanted to prevent the renarrowing of arteries, which is said to occur in some 25% of bare metal stent recipients.