The third generation of the Omega Platinum Chromium Bare-Metal Coronary Stent System (Boston Scientific) has received CE mark. The system incorporates Boston Scientific’s unique platinum chromium (PtCr) alloy designed specifically for coronary stenting and is intended to provide interventional cardiologists with a bare-metal stent with improved acute performance in treating patients with coronary artery disease. The company announced immediate commercialisation of this system in the European Union and other CE mark countries.
“In my experience, 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, Italy. “The Omega stent offers meaningful performance improvements without the tradeoffs associated with older stent alloys.”
This 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 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, 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 2.25mm to 4.50mm and lengths of 8mm to 32mm. Boston Scientific has the industry’s most comprehensive coronary stent portfolio, offering physicians and their patients the broadest size matrix and the only two-drug platform. The company received CE mark approval for the Promus Element Stent System in October 2009 and for the Taxus Element Stent System in May 2010.
The Omega Stent System is an investigational device, limited by applicable law to investigational use only and not available for sale in the USA.