FDA Approves First Bioabsorbable Polymer Drug-Eluting Stent in U.S. (includes video)

FDA Approves First Bioabsorbable Polymer Drug-Eluting Stent in U.S. (includes video)

Boston Scientific scores regulatory win for first-of-its-kind technology in the United States.

Boston Scientific Corp. received U.S. Food and Drug Administration (FDA) approval for the Synergy bioabsorbable polymer drug-eluting stent system (BP-DES) for the treatment of coronary artery disease.

With this FDA approval, Marlborough, Mass.-based Boston Scientific will begin selling what company officials claim is the “first and only” BP-DES in the United States. Both the drug coating and the polymer—which modulates drug release—are fully absorbed shortly after drug elution is complete at three months.

The Synergy stent provides synchronized drug and polymer absorption. It is designed to enable more rapid and complete arterial healing and as a result reduce the risk of complications associated with long-term polymer exposure compared to currently used drug-eluting stents with permanent polymers.

Existing DES devices reduce coronary restenosis, but the polymer remains on the stent after the drug is delivered. Long-term exposure to the polymer may cause inflammation, which delays healing and has been associated with complications, including neoatherosclerosis and stent thrombosis. The Synergy stent is designed for faster and sustained healing by eliminating long-term polymer exposure, company officials noted.

“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,” said Dean Kereiakes, M.D., principal investigator of the EVOLVE II trial and medical director at The Christ Hospital Heart & Vascular Center/The Lindner Research Center, in Cincinnati, Ohio. “The U.S. cardiology community will have access to a bioabsorbable polymer DES which will provide excellent clinical outcomes and should optimize vessel healing.”

Results previously reported from EVOLVE II, a global, multi-center, randomized, single-blind, noninferiority pivotal trial demonstrated no definite stent thrombosis after 24 hours. Four-year EVOLVE trial data demonstrated no stent thrombosis and a low target lesion revascularization rate of 1.1 percent.

Boston Scientific will continue to advance the clinical program supporting the Synergy stent with the initiation of the EVOLVE Short Dual Anti-Platelet Therapy (DAPT) study, expected during the first quarter of 2016. The company has received an investigational device exemption from the FDA for this prospective study designed to assess the safety of three-month use of DAPT in patients at high risk for bleeding undergoing percutaneous coronary intervention with the Synergy stent.

“The introduction of the first bioabsorbable polymer stent in the U.S. is a tremendous milestone in the evolution of stent technology,” said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific. “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.”

The Synergy stent features ultrathin stent struts with an abluminal bioabsorbable drug/polymer coating technology that is absorbed shortly after drug elution is complete at three months, thereby eliminating long-term polymer exposure.

The Synergy stent received CE mark in 2012.
Check out the Synergy in action here:

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