FDA approves two new lengths of the Promus Element stent system (Boston Scientific)

The FDA has approved the 32 mm and 38 mm lengths for the Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System, from Boston Scientific. 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. The approval is based on the PLATINUM Long Lesion Trial, 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 greater than 24 mm to less than or equal to 34 mm in length. The new lengths are immediately available in the US.