Promus Premier Everolimus-Eluting Platinum Chromium Stent System receives CE mark approval

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On 12 February 2013, Boston Scientific received CE mark approval for its Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System, the company’s next-generation durable polymer drug-eluting stent technology, and has begun its European market launch. According to a company release, the Promus Premier Stent System is designed to provide physicians improved drug-eluting stent performance in treating patients with coronary artery disease. It is the only platform to feature a customised Platinum Chromium stent architecture, the market-leading Everolimus drug coating and fluorinated co-polymer, and an enhanced stent delivery system.

“The customised Platinum Chromium stent architecture maintains the superior visibility, exceptional radial strength and fracture resistance, minimal recoil and outstanding clinical outcomes of platinum chromium Everolimus-Eluting stent while offering improved longitudinal strength,” said John Ormiston, Mercy Angiography, Auckland City, New Zealand. “In addition, the enhanced stent delivery system offers improved deliverability. Stent design is a balance of trade-offs and the Promus Premier Stent System appears to have it right.”

The Promus Premier Stent System was developed with input from physicians and, according to the company, the customised Platinum Chromium alloy stent architecture provides strength without compromising flexibility. An enhanced low-profile delivery system features a shorter, more visible tip, dual-layer balloon and Bi-Segment inner lumen catheter designed to facilitate precise stent delivery across challenging lesions. The Everolimus drug and fluorinated co-polymer stent coating have been studied in multiple randomised clinical trials demonstrating long-term safety and efficacy. The PLATINUM Workhorse Trial compared the Promus Element Stent (Platinum Chromium Everolimus-Eluting stent) to the Xience V Stent (Cobalt Chromium Everolimus-Eluting stent), and demonstrated that Platinum Chromium technology has superior clinical outcomes between years one and two.

“The Promus Premier Stent System is the latest example of our unparalleled pipeline of drug-eluting stent technologies and reflects our commitment to global drug-eluting stent market leadership,” said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific.  “We are proud that our research, clinical, regulatory and manufacturing teams delivered the next advance in stent technology in an expedited time. In partnership with physicians, we expect to continue to innovate and build on our industry-leading Platinum Chromium platform.”

The Promus Premier Stent System is currently offered in a matrix of 47 sizes, ranging in diameter from 2.25mm to 4.00mm and lengths of 8mm to 38mm on a Monorail catheter platform. This comprehensive offering provides cardiologists and their patients a broad range of options designed to best suit their needs. The Promus Premier Stent System is not available for sale in the United States or Japan.