FDA Clears 32, 38 MM Lengths for Promus Element Plus Stent
The 32 and 38 mm lengths of Boston Scientific's Promus Element Plus everolimus-eluting platinum chromium (PtCr) coronary stent system, the company's next-generation drug-eluting stent (DES) technology, are U.S. Food and Drug Administration (FDA)-approved and available in the United States. The stent system is now available in a matrix of 94 sizes, ranging in diameter from 2.25 mm to 4 mm and lengths of 8 mm to 38 mm on both Monorail and Over-the-Wire catheter platforms.
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 from greater than 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).
The company received FDA approval in 2012 and CE Mark approval for the Promus Element stent system in 2009. The Promus was approved by the FDA and received CE Mark in 2011. The Taxus Element paclitaxel-eluting stent system received CE Mark approval in 2010 and approval in Japan in 2011. It received FDA approval in 2011 and is marketed in the U.S. as the Ion paclitaxel-eluting stent system.
For more information: www.bostonscientific.com