Boston Scientific has received CE Mark approval for its Synergy everolimus-eluting platinum chromium coronary stent system featuring an abluminal (outer) bioabsorbable polymer coating.
The Synergy stent has a proprietary PLGA polymer and everolimus-drug coating that dissipate in three months, according to the Natick, Mass.-based company, which added the absorption of the coating is the result of seven years of research and development.
The clinical program supporting Synergy builds on the EVOLVE six-month study results, which demonstrated non-inferiority to Boston Scientific's Promus Element stent for the primary angiographic endpoint of in-stent late loss. A pivotal trial, EVOLVE II, has been designed to support FDA and Japanese Ministry of Health, Labor and Welfare approval of Synergy and is expected to begin enrollment later this year. EVOLVE II is a global, multicenter, randomized, controlled, pivotal trial that will enroll 1,684 patients in 160 sites globally.
Synergy will be available in various sizes to select centers in Europe and other areas by early 2013. The company said this "limited market release" is expected to provide additional data to support the clinical and economic benefits of this bioabsorbable technology. A commercial launch of the Synergy is planned for early 2014.
The Synergy stent is an investigational device, not available for sale in the U.S. and Japan.