Boston Scientific wins CE mark for polymer drug-eluting stent system

12 February 2013 (Last Updated February 12th, 2013 18:30)

The European Union has granted CE mark certification to a new polymer-based drug-eluting stent (DES) system, developed by Boston Scientific to treat patients with coronary artery disease.

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The European Union has granted CE mark certification to a new polymer-based drug-eluting stent (DES) system, developed by Boston Scientific to treat patients with coronary artery disease.

Available in a matrix of 47 sizes, ranging in diameter from 2.25mm to 4mm and lengths of 8mm to 38mm on a Monorail catheter platform, the Promus Premier everolimus-eluting platinum chromium coronary stent system helps to keep the coronary artery open and allows the blood to flow more freely.

The DES system features a combination of everolimus drug and fluorinated co-polymer, and a customised platinum chromium (PtCr) stent architecture to provide strength without compromising flexibility.

Mercy Angiography interventional cardiologist John Ormiston said; "The customised 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."

The system also includes a low-profile delivery system, which features a shorter, more visible tip, a dual-layer balloon and a Bi-Segment inner lumen catheter to facilitate precise stent delivery across challenging lesions.

Boston Scientific said the everolimus drug and fluorinated co-polymer stent coating have been studied in multiple randomised clinical trials including the PLATINUM Workhorse trial to demonstrate long-term safety and efficacy.

The Workhorse trial compared the Promus Element stent (platinum chromium everolimus-eluting stent) with the Xience V stent (cobalt chromium everolimus-eluting stent) and found that platinum chromium technology has superior clinical outcomes between years one and two.

Boston Scientific interventional cardiology president Kevin Ballinger said; "In partnership with physicians, we expect to continue to innovate and build on our industry-leading Platinum Chromium platform."

The company is releasing the Promus Premier stent system in Europe, however, it is not available for sale in the US or Japan.


Image: The Promus Premier everolimus-eluting platinum chromium coronary stent system helps to keep the coronary artery open and allows the blood to flow more freely. Photo: Courtesy of Boston Scientific.