FDA approves Promus Premier stent for CAD-Boston Scientific

The FDA has given approval for the Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System, from Boston Scientific, for treating patients with Coronary Artery Disease. The Everolimus drug and PVDF-HFP stent coating have been studied in multiple randomized clinical trials demonstrating long-term safety and efficacy.

The PLATINUM Clinical Trial Program demonstrated exceptional safety and efficacy of the PROMUS Element Stent System (Platinum Chromium Everolimus-Eluting stent) when compared to the Xience V Stent (Cobalt Chromium Everolimus-Eluting stent), including a significant reduction in bail-out stenting. Further review of the Platinum data demonstrated that the PROMUS Element Stent System is associated with significantly less vessel straightening in severely angulated lesions and resulted in numerically lower clinical event rates out to three years.