Boston Scientific Corporation (NYSE: BSX) announced that its PROMUS® Element™ Everolimus-Eluting Coronary Stent System has received CE Mark approval for use in patients with diabetes(1) and those experiencing an acute myocardial infarction (AMI), or heart attack.
“We are pleased to receive these expanded indications for the high-risk diabetic and AMI patient groups,” said Keith D. Dawkins, M.D., Senior Vice President and Chief Medical Officer for Boston Scientific’s Cardiology, Rhythm and Vascular Group. “The platinum chromium PROMUS Element Stent has been well received by physicians since its launch last year in CE Mark countries, and these new indications are important additions, especially as the prevalence of diabetes continues to increase dramatically worldwide.”
Boston Scientific is a leader in the treatment of cardiovascular disease and has the broadest offering of drug-eluting stents and the greatest number of specific patient indications.
The PROMUS Element Stent features a novel platinum chromium alloy and innovative stent design, which combine to offer greater radial strength and flexibility while reducing stent recoil. The stent geometry helps create consistent lesion coverage and drug distribution while improving deliverability, which is enhanced by an advanced catheter delivery system. The higher density platinum chromium alloy provides superior visibility while permitting thinner struts compared to prior-generation stents(2).
The Company received CE Mark approval for the PROMUS Element Everolimus-Eluting Stent System in October 2009 and for the TAXUS® Element™ Paclitaxel-Eluting Stent System in May, which included a specific indication for the treatment of diabetic patients. Both Element systems incorporate the same platinum chromium alloy, innovative stent design and advanced catheter delivery system.
In the U.S., the Company expects Food and Drug Administration approval for the TAXUS Element Stent System in mid 2011 and for the PROMUS Element Stent System in mid 2012. In Japan, the Company expects approval for the TAXUS Element Stent System in late 2011 or early 2012 and for the PROMUS Element Stent System in mid 2012.
In the U.S., the TAXUS Element Stent and the PROMUS Element Stent are investigational devices and are limited by applicable law to investigational use only and are not available for sale.
(1) For patients with concomitant diabetes mellitus.
(2) Based on bench testing. Data on file with Boston Scientific.
Source: Boston Scientific