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Platinum-chromium coronary stent has bio-absorbable PLGA polymer coating

Boston Scientific : 08 November, 2012  (New Product)
Boston Scientific Corporation has received CE Mark approval for its Synergy Everolimus-Eluting platinum chromium coronary stent system, which features an ultra-thin abluminal (outer) bioabsorbable polymer coating.

The Synergy Stent is unique in that its proprietary PLGA polymer and verolimus drug coating dissipate within three months. This has the potential to improve post-implant vessel healing and will eliminate long-term polymer exposure, a possible cause of late adverse events.

"With the Synergy Stent, drug release and polymer absorption occur in parallel and are complete at about three months after stent implantation," says Prof Ian Meredith, Director of Monish Heart, at Monish Medical Centre in Melbourne, Australia and the principal investigator of the Evolve clinical study. "This advance may improve long-term safety and efficacy compared to current-durable polymer DES and perhaps even reduce the need for prolonged dual antiplatelet therapy."

The timely absorption of the Synergy Stent coating is the result of seven years of research and development to create what Boston Scientific believes to be the ideal blend of drug and polymer with advanced coating technologies.

"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," says 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 revascularisation (TLR) rate of 1.1% and a stent thrombosis (ST) rate of 0.0%. A pivotal trial, Evolve II, has been designed to support US 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 1684 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 centres 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 then planned for early 2014.

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