Boston Scientific’s (NYSE:BSX) next-generation semi-bioabsorbable drug-eluting stent proved as safe and effective in treating coronary artery lesions as its well-established Promus Element system, the company revealed at the the EuroPCR conference in Paris today.
Boston Scientific unveiled 1-year and 6-month results of its Evolve 1st human use trial of the Synergy device, a drug-eluting coronary stent with a drug and polymer coating designed to be absorbed by the body within 4 months of implantation, leaving behind a bare-metal stent.
The technology is intended to allow faster and more complete healing of the vessel when compared with traditional drug-eluting stents, while providing as much reduction in restenosis.
The Evolve study included 291 patients who were randomized to receive either Synergy with a half-dose of the everolimus, Synergy with a full dose of the drug, or the commercially available Promus Element platinum chromium drug-eluting stent. There were no cardiac-related deaths and no instances of stent thrombosis at 1 year, and researchers noted "very low rates" of revascularization, according to a press release.
The latest results add to data released at last year’s Transcatheter Cardiovascular Therapeutics symposium in November, when Boston Scientific touted 6-month results finding that "outcomes for diameter stenosis and binary restenosis showed no statistical differences between the Synergy and Promus Element stents."
New data from the trial is expected to support a bid for CE Mark approval in the European Union, which may come this year, but the larger race is in bringing a bioabsorbable stent to the U.S. market.
Abbott (NYSE:ABT) won CE Mark for its Absorb fully bioresorbable vascular scaffold. in January 2011, planning commercial launch in Europe by the end of this year. The device giant in November touted long-term clinical results at 5 years, 2 years and 18 months from its 2-stage Absorb trial.
Whereas the polymer coating in Boston Scientifc’s Synergy stent is absorbed into the body, the Abosrb stent is designed to completely dissappear after about 2 years.
Boston Scientific subsidary Guidant Corp.
*Updated May 15, 2012, at 3:30 p.m.: This article mistakenly included Medtronic’s Resolute stent as a bioabsorbable stent. It is a drug-eluting stent, but is not absorbable.