Boston Scientific received CE Mark approval and is gearing up for a limited European market release of its SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System. The stent features a very thin layer of a bioabsorbable polymer coating on its external surface that disappears along with the attached immunosuppressant within three months.
The company believes that the new polymer technology, which it spent seven years developing, may “improve post-implant vessel healing and will eliminate long-term polymer exposure, a possible cause of late adverse events.”
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“In addition to its innovative coating, the foundation of the SYNERGY Stent is our proprietary platinum chromium alloy and an enhanced stent design which allow for thinner struts, increased visibility and an extremely low crossing profile for easier deliverability,” said Kevin Ballinger, president of the Interventional Cardiology division at Boston Scientific. “We believe that the result is a premium workhorse drug-eluting stent that eliminates long-term polymer exposure, promotes optimal healing and provides confident deliverability.”
The SYNERGY Stent is supported by a rigorous clinical program builds on the EVOLVE six-month study results which demonstrated non-inferiority to the Boston Scientific PROMUS Element™ Stent for the primary angiographic endpoint of in-stent late loss, a proxy for efficacy. At 12 months, the SYNERGY Stent demonstrated a target lesion revascularization (TLR) rate of 1.1 percent and a stent thrombosis (ST) rate of 0.0 percent. A pivotal trial, EVOLVE II, has been designed to support U.S. Food and Drug Administration and Japanese Ministry of Health, Labor and Welfare approval of the SYNERGY Stent System and is expected to begin enrollment later this year. EVOLVE II is a global, multicenter, randomized, controlled (RCT), pivotal trial that will enroll 1,684 patients in 160 sites across the globe. Boston Scientific anticipates additional studies to assess outcomes, including the potential for reduced dual antiplatelet therapy.
The SYNERGY Stent will be available in a full range of sizes to select centers in Europe and other geographies by early 2013. This limited market release is expected to provide additional data to support the clinical and economic benefits of this novel bioabsorbable technology. A broad commercial launch of the SYNERGY Stent is planned for early 2014.