Boston Scientific Announces Canadian Approval and Launch of PROMUS Element™ Plus Stent System
Platinum chromium coronary stent with enhanced delivery system now available in Canada
NATICK, Mass., April 25, 2012 /CNW/ - Boston Scientific Corporation (NYSE: BSX) announces Health Canada approval and market launch of the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in Canada. The first patient implant in Canada using the new device was recently performed by Philippe L'Allier, M.D., Cath Lab Director at the Montreal Heart Institute. The new stent system incorporates the platinum chromium (PtCr) alloy and innovative stent design of the PROMUS Element Stent with an enhanced catheter delivery system engineered for improved performance in treating patients with coronary artery disease. The Company plans to begin marketing the product immediately in Canada.
"The unique PtCr alloy and stent architecture of the PROMUS Element Stent offer significant advantages in conformability, radial strength and visibility compared to other stent platforms," said Dr. L'Allier. "The best-in-class deliverability of the PROMUS Element Plus Stent System will help in accessing challenging lesions."
The PROMUS Element Stent, part of the PROMUS Element Stent System and the PROMUS Element Plus Stent System, uses a proprietary PtCr alloy designed specifically for coronary stenting, which enables enhanced visibility, less recoil, excellent conformability and higher radial strength. The PROMUS Element Plus Stent System employs an advanced low-profile delivery system featuring a dual-layer balloon designed to enable precise stent delivery across challenging lesions and reduce balloon growth during inflation to facilitate high-pressure stent deployment. The everolimus drug and fluorinated copolymer used on the PROMUS Element Stent have been studied in multiple randomized clinical trials and 'real-world' registries, demonstrating excellent long-term safety and efficacy.
"We are pleased to introduce the PROMUS Element Plus Stent System to physicians and patients in Canada," said Kevin Ballinger, President of the Interventional Cardiology Division at Boston Scientific. "This advanced stent is supported by strong clinical outcomes from the PLATINUM trial, which demonstrated very low rates of revascularization and stent thrombosis at one and two years. It is the latest example of Boston Scientific's commitment to market leadership and continued innovation in drug-eluting stents."
In the U.S., the PROMUS Element Plus Stent System was approved by the Food and Drug Administration in 2011.
About Boston Scientific
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
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SOURCE Boston Scientific Corporation
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