Boston Scientific Gains CE Mark Approval for Synergy DES With Bioabsorbable Polymer

October 31, 2012—Boston Scientific Corporation (Natick, MA) announced that it has received CE Mark approval for the Synergy everolimus-eluting platinum chromium (PtCr) coronary stent system with an ultra-thin abluminal bioabsorbable polymer coating.

The device will be available in a full range of sizes to select centers in Europe and other geographies by early 2013, with a broad commercial launch in early 2014. The initial limited market release is expected to provide additional data to support the clinical and economic benefits of the Synergy stent and its bioabsorbable technology, the company stated.

According to Boston Scientific’s press release, the Synergy stent features the company’s bioabsorbable poly-lactic-co-glycolic acid polymer and everolimus drug coating that dissipate within 3 months of implantation, which has the potential to improve postimplant vessel healing and will eliminate long-term polymer exposure.

The Synergy drug-eluting stent DES was evaluated in the EVOLVE clinical study, which supported the European approval. The company announced that Stefan Verheye, MD, presented 6-month and 1-year EVOLVE data at the EuroPCR 2012 conference in Paris on May 15, 2012. Prof. Ian Meredith, MD, Director of Monish Heart at Monish Medical Centre in Melbourne, Australia, served as Principal Investigator of the EVOLVE study.

“With the Synergy stent, drug release and polymer absorption occur in parallel and are complete at about 3 months after stent implantation,” commented Prof. Meredith in the company’s press release. “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 the EVOLVE 6-month results, the Synergy stent demonstrated noninferiority 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 rate of 1.1% and a stent thrombosis rate of 0%.

The company advised that 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, 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 system is currently an investigational device, not available for sale in United States and Japan, stated Boston Scientific.