Boston Scientific Attains Approval for Polymer Stent System

The medical device has received CE Mark approval for its Promus PREMIER coronary stent.

Boston Scientific Corporation has received CE Mark approval for the Promus PREMIER(TM) Everolimus-Eluting Platinum Chromium Coronary Stent System, the company's next-generation durable polymer drug-eluting stent (DES) technology, and is starting its European market launch. The Promus PREMIER Stent System is designed to provide physicians improved DES performance in treating patients with coronary artery disease. It is the only platform to feature a customized Platinum Chromium (PtCr) stent architecture, the market-leading Everolimus drug coating and fluorinated co-polymer, and an enhanced stent delivery system. 

Coronary heart disease is a narrowing of the vessels that supply blood and oxygen to the heart. Recent statistics from the European Heart Network and the European Society of Cardiology show it is the single most common cause of death in Europe accounting for 1.8 million deaths in Europe per year. Patients living with coronary heart disease, also known as coronary artery disease, may experience pain, shortness of breath and fatigue. They may also be at risk for a heart attack. One treatment option is the placement of a stent in the artery to help keep it open and allow the blood to flow more freely.

"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," said John Ormiston, M.D., 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. The customized 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(TM) 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 randomized clinical trials demonstrating long-term safety and efficacy. The PLATINUM Workhorse Trial compared the PROMUS Element(TM) Stent (Platinum Chromium Everolimus-Eluting stent) to the Xience V(TM) 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 DES 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 2.25 mm to 4.00 mm and lengths of 8 mm to 38 mm 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.

About Boston Scientific

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. 

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