Boston Scientific has obtained CE mark approval for its Synergy Everolimus-Eluting platinum chromium coronary stent system, designed to improve post-implant vessel healing.
The coronary stent, which features a combination of bioabsorbable PLGA polymer and everolimus drug, creates a ultra-thin, uniform coating that is applied to the abluminal (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 added.
The approval was based on the data from a prospective, randomized, single-blind EVOLVE six-month study, which compared Synergy with the company’s PROMUS Element stent, featuring a durable polymer coating applied to the entire stent.
The results demonstrated non-inferiority to the PROMUS stent for the primary angiographic endpoint of in-stent late loss, a proxy for efficacy.
In addition, at 12 months the Synergy system demonstrated a target lesion revascularization (TLR) rate of 1.1% and a stent thrombosis rate of 0%.
Monish Medical Center Monish Heart professor and director and EVOLVE study principal investigator 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 added.
In addition to EVOLVE study, the company is planning to start 1,684 patient Synergy stentbased EVOLVE II trial, designed to support for the US Food and Drug Administration and Japanese Ministry of Health, Labor and Welfare approvals.