Boston Scientific Corporation has received CE Mark for its OMEGA Platinum Chromium Bare-Metal Coronary Stent System, the company's third-generation coronary stenting technology.

It uses the company's unique platinum chromium (PtCr) alloy designed specifically for coronary stenting and is intended to provide doctors with improved acute performance in treating patients with coronary artery disease.

Boston Scientific said it will immediately start marketing the OMEGA Stent System in the European Union and other countries that use the CE Mark.

The platinum chromium alloy and design used in the OMEGA Stent "offer excellent deliverability, visibility and conformability while improving radial strength and reducing stent recoil", said Antonio Colombo, director of the Cardiac Catheterisation Laboratory at Columbus Hospital and San Raffaele Hospital in Milan.

"The OMEGA Stent and platinum chromium alloy offer meaningful performance improvements without the trade-offs associated with older stent alloys."

It is part of the company's PtCr stent series that includes the TAXUS Element Paclitaxel-Eluting Stent System and the PROMUS Elemen Everolimus-Eluting Stent System.

The high density of the alloy provides better visibility, while also allowing thinner struts compared to older stents.

Keith D Dawkins, senior vice-president and chief medical officer for Boston Scientific's Cardiology, Rhythm and Vascular Group, remarked: "The OMEGA Stent complements the PtCr Stent series, and gives interventional cardiologists the option to treat patients with a paclitaxel, everolimus or bare-metal stent."

Mike Phalen from Boston Scientific explained that the two other PtCr stents have been "well received" by doctors since their launch.

"We are confident our platinum chromium technology will strengthen our worldwide stent market leadership," he added.

Both the previous PtCr stent technologies have already received CE Mark approval, and the company anticipates that it will get the go-ahead to commercialise these in America from the US Food and Drug Administration by 2012.

The new OMEGA Stent is offered in 48 sizes, ranging in diameter from 2.25 mm to 4.50 mm and lengths of 8 mm to 32 mm.

Source:


Boston Scientific Announces European Approval and Launch of OMEGA™ Platinum Chromium Stent System (07/03/11) 

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