FDA approves Boston Scientific’s Synergy absorbable stent

The FDA approved Boston Scientific‘s (NYSE:BSX) Synergy absorbable 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, which is made of a bioabsorbable polymer, is designed to dissolve completely after delivering its payload of the anti-restenosis drug everolimus. The stent elutes the drug for about 3 months and 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.”

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