Boston Scientific has received CE mark approval for the Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System featuring an ultra-thin abluminal (outer) bioabsorbable polymer coating.
Synergy features a PLGA polymer and everolimus drug coating that dissipates by three months. According to a company release, “this innovation has the potential to improve post-implant vessel healing and will eliminate long-term polymer exposure a possible cause of late adverse events.”
The safety and efficacy of the Synergy stent is supported by results from the EVOLVE trial. At six months, the Synergy stent demonstrated non-inferiority to the Promus Element Stent (Boston Scientific) 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%.
“With the Synergy stent, drug release and polymer absorption occur in parallel and are complete at about three months after stent implantation,” said Ian Meredith, professor and director of Monish Heart, at Monish Medical Centre in Melbourne, Australia, and the principal investigator of the EVOLVE clinical study. “This exciting advance may improve long-term safety and efficacy compared to current durable polymer drug-eluting stents and perhaps even reduce the need for prolonged 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 planned for early 2014.
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 enrolment later this year. EVOLVE II is a global, multicentre, randomised, controlled (RCT), pivotal trial that will enrol 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.
“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.”