FDA Approves New Lengths for Boston Scientific's Promus Element Plus

June 4, 2012—Boston Scientific Corporation (Natick, MA) announced US Food and Drug Administration approval and the United States market launch of 32-mm and 38-mm lengths for the Promus Element Plus everolimus-eluting platinum chromium coronary stent system.

According to 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 the Boston Scientific Monorail and over-the-wire catheter platforms. The Promus Element Plus stent system was approved by the FDA and received CE Mark in 2011.

Louis Cannon, MD, program director at the Heart and Vascular Institute of the Northern Michigan Hospital, has used the 32 mm and 38 mm length stents as part of the company's PLATINUM clinical trial program.

“The extensive evidence base from the PLATINUM trials documents the excellent safety and efficacy of the Promus Element Plus stent system, including extremely low rates of stent thrombosis,” said Dr. Cannon in the company's press release. “The impressive patient outcomes achieved with the Promus Element Plus stent system in clinical study and in day-to-day practice are especially relevant when treating patients with long lesions, which are often challenging cases representing complex disease. What's more, we're achieving these results with a highly deliverable stent system that features stents of unparalleled radial strength, conformability and visibility.”