The FDA approved Boston Scientific‘s (NYSE:BSX) Synergy drug-eluting stent for treating coronary artery disease, sending BSX shares up today and making BSX the 1st U.S. entrant on the next front in the stent wars.
The Marlborough, Mass.-based company said the Synergy device’s bioabsorbable polymer is designed to dissolve completely after delivering its payload of the anti-restenosis drug everolimus, leaving behind a bare-metal stent. Synergy elutes the drug for about 3 months and the polymer coating is absorbed “shortly” thereafter, Boston Scientific said.
The news pushed BSX shares up 2.8% to $17.40 apiece today in pre-market trading, before their $17.36 opening this morning. The company said it’s asked the FDA for an investigational device exemption for a new, 3-month study evaluating Synergy in conjunction with a short course of dual anti-platelet therapy and expects to launch the trial, Evolve DAPT, during the 1st quarter next year.
“The introduction of the first bioabsorbable polymer stent in the U.S. is a tremendous milestone in the evolution of stent technology,” interventional cardiology president Kevin Ballinger said in prepared remarks. “The Synergy stent is a next generation therapy designed to improve patient outcomes and ultimately reduce health care costs associated with the treatment of coronary artery disease.”
“Data from the Evolve II trial, which included the most complex patient population studied in a U.S. regulatory approval stent trial, demonstrated exceptional performance and safety of the Synergy stent,” added Evolve II principal investigator Dr. Dean Kereiakes of Cincinatti’s Christ Hospital Heart & Vascular Center. “The U.S. cardiology community will have access to a bioabsorbable polymer DES which will provide excellent clinical outcomes and should optimize vessel healing.”
Dr. Craig Thompson, senior vice president & chief medical officer for Boston Scientific’s interventional cardiology division, told MassDevice.com that Synergy is expressly designed to promote healing in the arterial wall.
“The concept and goal is to reduce the adverse events that are caused by long-term polymer exposure to the artery,” Thompson told us from the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco. “I think there were 2 fundamental unmet needs. One is that physicians and patients are tethered to this dual antiplatelet therapy to protect the stent. We know that Synergy heals differentially and we believe it’s going to lend itself to having lower thrombotic events, in what we have seen thus far in the data that’s available.
“Second is that permanent-polymer drug-eluting stents, the current generation, while an improvement on the 1st generation, we still see a loss of efficacy, safety and efficacy, of about 2% per year, every year after the first year. The results don’t stand up as well over time,” he said. “We believe that this is from chronic inflammation in the artery and neoatherosclerosis, and by reducing that inflammation we’ll improve outcomes with this product.”