Boston Scientific's Promus Premier Drug-Eluting Stent Receives CE Mark Approval

February 12, 2013—Boston Scientific Corporation (Natick, MA) announced that it has received CE Mark approval for the Promus Premier everolimus-eluting platinum-chromium (PtCr) coronary stent system, the company's next-generation durable-polymer drug-eluting stent (DES) technology. The company is starting its European market launch. The Promus Premier stent system is currently offered in a matrix of 47 sizes, ranging in diameter from 2.25 mm to 4 mm and lengths of 8 mm to 38 mm on a Monorail catheter platform. The Promus Premier stent system is not available for sale in the United States or Japan, advised the company.

According to Boston Scientific, the Promus Premier stent system is designed to provide physicians with improved DES performance in treating patients with coronary artery disease. The device features the company's customized PtCr stent architecture, the everolimus drug coating, fluorinated copolymer, and an enhanced stent-delivery system. John Ormiston, MD, of Mercy Angiography, Auckland City, New Zealand, commented on the device in the company's press release.

“The customized platinum-chromium stent architecture maintains the superior visibility, exceptional radial strength and fracture resistance, minimal recoil, and outstanding clinical outcomes of a PtCr everolimus-eluting stent while offering improved longitudinal strength,” stated Dr. Ormiston. “In addition, the enhanced stent-delivery system offers improved deliverability. Stent design is a balance of tradeoffs, and the Promus Premier stent system appears to have it right.”

Boston Scientific noted that the Promus Premier's PtCr-alloy stent architecture provides strength without compromising flexibility, and that the low-profile delivery system features a shorter, more visible tip; dual-layer balloon; and the company's Bi-Segment inner-lumen catheter that is designed to facilitate precise stent delivery across challenging lesions. The everolimus-drug-and-fluorinated-copolymer stent coating have demonstrated long-term safety and efficacy in multiple randomized clinical trials, and the PtCr technology has shown superior clinical outcomes between 1 and 2 years in the PLATINUM Workhorse trial that compared the Promus Element PtCr everolimus-eluting stent to the Xience V cobalt-chromium everolimus-eluting stent (Abbott Vascular, Santa Clara, CA).