Boston Scientific Receives FDA Approval for 32 MM and 38 MM Lengths for PROMUS Element™ Plus Platinum Chromium Stent System
The U.S. Food and Drug Administration (FDA) has provided Boston Scientific Corporation (NYSE: BSX) regulatory approval of 32 mm and 38 mm lengths for the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System, the company's next-generation drug-eluting stent (DES) technology. The PROMUS Element Stent is built on an innovative platinum chromium (PtCr) platform with the market-leading everolimus drug and is designed to provide physicians exceptional DES performance in treating patients with coronary artery disease. The 32 and 38 mm lengths of the PROMUS Element Plus Stent System are immediately available in the U.S.
The PROMUS Element Plus Stent System is now available in a matrix of 94 sizes, ranging in diameter from 2.25 mm to 4.00 mm and lengths of 8 mm to 38 mm on both Monorail® and Over-the-Wire catheter platforms. Boston Scientific has the industry's most comprehensive coronary stent portfolio, and is the only company to offer physicians a choice of two proven drugs on an advanced coronary stent platform. In addition to the PROMUS Element Plus Stent System, Boston Scientific offers the OMEGA™ Bare-Metal Stent System and TAXUS® Element™ Paclitaxel-Eluting Stent System in international markets and the ION™ Paclitaxel-Eluting Stent System in the U.S.
Clinical data support the safety and efficacy of the PROMUS Element Stent in patients with long coronary lesions. As part of the comprehensive PLATINUM Clinical Trial program, the one year data from the PLATINUM Long Lesion Trial demonstrated low rates of revascularization while reporting no cardiac death, myocardial infarction or stent thrombosis in patients with long coronary lesions. The PLATINUM Long Lesion Trial is a prospective, multicenter, single-arm subtrial designed to evaluate the safety and effectiveness of the PROMUS Element Stent for the treatment of de novo coronary lesions >24 mm to less than or equal to 34 mm in length (greater than or equal to 2.50 to less than or equal to 4.25 mm in diameter).
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