FDA Approves Longer Lengths Of PROMUS Element Plus Stent

In short

Boston Scientific Corporation has announced the gaining of FDA clearance of two longer lengths of its PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System. By now offering 32 and 38 mm lengths of the PROMUS Element Plus Stent System the company is opening the door for the treatment of longer lesions. The new sizes are immediately available in the U.S.

Background

The PROMUS Element Stent is built on an innovative platinum chromium (PtCr) platform with the market-leading everolimus drug and 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 is the only company to offer physicians a choice of two proven drugs on an advanced coronary stent platform, with both its PROMUS Element Plus and TAXUS® Element Paclitaxel-Eluting Stent System in international markets and the ION Paclitaxel-Eluting Stent System in the U.S.

Supporting study

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 revascularisation while reporting no cardiac death, myocardial infarction or stent thrombosis in patients with long coronary lesions. The PLATINUM Long Lesion Trial is a prospective, multicentre, single-arm subtrial designed to evaluate the safety and effectiveness of the PROMUS Element Stent for the treatment of de novo coronary lesions between 24 mm and 34 mm in length (greater than or equal to 2.50 to less than or equal to 4.25 mm in diameter).

Clinician comments

“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.”

Company comments

“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.”

Regulatory summary

Boston Scientific received CE Mark approval for the PROMUS Element Stent System in 2009 followed by FDA approval and CE Mark in 2011 for PROMUS Element Plus. 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, PR Newswire