NATICK, Mass.,  The U.S. Food and Drug Administration (FDA) has provided Boston Scientific Corporation 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). 

"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 Louis Cannon, M.D., FACC, FSCAI, FACP, program director at the Heart and Vascular Institute of the Northern Michigan Hospital, who has used the 32 mm and 38 mm length stents as part of the PLATINUM Clinical Trial Program.  "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."

"This latest regulatory approval addressing the long sizes of the PROMUS Element Plus Stent System marks yet another important milestone for Boston Scientific — we now offer the market-leading everolimus drug on our PtCr stent platform in the broadest range of lengths and diameters in the United States," said Kevin Ballinger, president of Boston Scientific's cardiovascular division.  "We continue to secure regulatory approvals and introduce the breakthrough PROMUS Element Plus Stent System, now available in the United States and the European Union.  Notably, this is an internally developed and manufactured drug-eluting stent system, underscoring Boston Scientific's commitment to global DES market leadership."

The company received CE Mark approval for the PROMUS Element Stent System in 2009.  The PROMUS Element Plus Stent System 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. 

Source: Boston Scientific Corporation