Another news release timed to coincide with EACTS sees Boston Scientific Corporation announcing CE Mark approval for the Synergy™ Everolimus-Eluting Platinum Chromium Coronary Stent System featuring its ultra-thin abluminal bioabsorbable polymer coating which holds the promise of reducing late adverse events.
The Synergy Stent is the latest innovation in drug-eluting stent technology from Boston Scientific. It is unique in that its proprietary PLGA polymer and everolimus drug coating dissipate by three months. 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 timely absorption of the stent’s 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.
The Synergy Stent has gone through what Boston Scientific refers to as a rigorous clinical programme, building on the EVOLVE six-month study results which demonstrated non-inferiority to the company’s 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 percent and a stent thrombosis (ST) rate of 0.0 percent.
A pivotal trial, EVOLVE II, has been designed to support U.S. FDA and Japanese approval and is expected to begin enrollment later this year. EVOLVE II is a global, multicentre, randomised, controlled, 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 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 is planned for early 2014.
“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, M.B.B.S., Ph.D., 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 DES and perhaps even reduce the need for prolonged 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.”
The Synergy Stent System is an investigational device, not available for sale in United States and Japan.
Full release here
Source: Boston Scientific Corporation, PR Newswire