Boston Scientific has received the European CE mark for the OMEGA Platinum Chromium (PtCr) Bare-Metal Coronary Stent System. This is essentially a bare metal version of the company’s previously approved PtCr line of stents.
The OMEGA Stent System is part of Boston Scientific’s PtCr Stent series, which includes the TAXUS® Element™ Paclitaxel-Eluting Stent System and PROMUS Element™ Everolimus-Eluting Stent System. All three stents feature the novel PtCr alloy and an innovative stent design, which combine to offer greater radial strength and flexibility while reducing stent recoil. The higher density alloy provides superior visibility while permitting thinner struts compared to prior-generation stents. The enhanced delivery system features a dual-layer balloon and is engineered to improve access to challenging lesions.
"The platinum chromium PROMUS Element and TAXUS Element Stents have been well received by physicians since their launch in CE Mark countries, and we are pleased to offer a bare-metal coronary stent built on the same PtCr platform," said Mike Phalen, Executive Vice President and President, International for Boston Scientific. "The OMEGA Stent is the latest example of our commitment to continued innovation in coronary stenting. We are confident our platinum chromium technology will strengthen our worldwide stent market leadership."
"The positive clinical data from our PtCr (Element) trials support the acute performance benefits provided by our new platinum chromium stent platform," said Keith D. Dawkins, M.D., Senior Vice President and Chief Medical Officer for Boston Scientific’s Cardiology, Rhythm and Vascular Group. "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."
The 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.