Technology | June 04, 2012

FDA Clears 32, 38 MM Lengths for Promus Element Plus Stent

Promus Element Plus Offers Broadest Array of Everolimus DES Lengths, Diameters in U.S.

June 4, 2012 — Boston Scientific Corp. has received U.S. Food and Drug Administration (FDA) regulatory approval of 32 mm and 38 mm lengths for the Promus Element Plus everolimus-eluting platinum chromium (PtCr) coronary stent system, the company's next-generation drug-eluting stent (DES) technology. The 32 and 38 mm lengths of the Promus Element Plus are immediately 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. In addition to the Promus Element Plus, 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 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 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 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."

The company received 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.

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