The FDA approved a new bioabsorbable polymer drug-eluting stent system for coronary artery disease.
The US Food and Drug Administration approved Boston Scientific's Synergy system, a bioabsorbable polymer-eluting stent for the treatment of coronary artery disease.
The company, based in Marlborough, Mass., said the device is fully absorbed "shortly after drug elution is complete at three months."
The stent provides synchronized drug release and polymer absorption.
While existing devices reduce coronary restenosis, the polymer typically remains on those stents after the drug is delivered. That can ultimately cause inflammation, delaying healting and sometimes causing complications. Those include neoartherosclerosis and stent thrombosis.
"Data from the EVOLVE II trial, which included the most complex patient population studied in a US regulatory approval stent trial, demonstrated exceptional performance and safety of the Synergy stent," said that trial's principal invesigator Dean Kereiakes, MD of the Christ Hospital Heart & Vascular Center/The Lindner Research Center in Cincinnati, Ohio.
The device features ultrathin stent struts coated with an abluminal bioabsorbable drug/polymer.