The European Union has granted CE mark certification to Boston Scientific’s coronary stent system with bioabsorbable technology, designed to improve post-implant vessel healing.
The Synergy Everolimus-Eluting platinum chromium coronary stent system features a combination of bioabsorbable PLGA polymer and everolimus drug to create an ultra-thin, uniform coating that is applied to the outer surface of the stent.
Boston Scientific interventional cardiology division president Kevin Ballinger said the stent also features the company’s proprietary platinum chromium alloy and is designed to allow for thinner struts, increased visibility and a low crossing profile for easier deliverability.
"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," Ballinger said.
The approval was based on the data from a prospective, randomised, single-blind EVOLVE six-month study, which compared Synergywith the company’s Promus Element stent featuring a durable polymer coating applied to the entire stent (inner and outer) surface.
The results demonstrated non-inferiority to the Promus stent for the primary angiographic endpoint of in-stent late loss, a proxy for efficacy.
At 12 months the Synergy system also demonstrated a target lesion revascularisation (TLR) rate of 1.1% and a stent thrombosis rate of 0%.
Monish Medical Centre Monish Heart professor and director and EVOLVE study principal investigator Dr Ian Meredith said with the bioabsorbable stent, drug release and polymer absorption occur in parallel and are complete at about three months after stent implantation.
"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," Meredith said.
In addition to the EVOLVE study, the company is planning to enrol 1,684 patients for its EVOLVE II trial, designed to support US Food and Drug Administration and Japanese Ministry of Health , Labor and Welfare approvals for the stent.
Synergy will be available in a full range of sizes in selected centres in Europe and other geographies by early 2013, while a broad commercial launch is planned for early 2014, according to the company.
Image: Boston Scientific’s corporate headquarters in Natick, Massachusetts, US. Photo: Courtesy of Boston Scientific.