A drug-delivering and self-dissolving arterial stent made by Boston Scientific has received Food and Drug Administration approval, the Marlborough-based company announced.
Boston Scientific’s SYNERGY Bioabsorbable Polymer Drug-Eluting Stent System (BP-DES) has been approved for the treatment of coronary artery disease. It is the only stent of its kind in the country, according to the company.
With this FDA approval, the company will begin commercialization of the stent system, Boston Scientific said in a statement Monday.
“The introduction of the first bioabsorbable polymer stent in the U.S. is a tremendous milestone in the evolution of stent technology,” Kevin Ballinger, president of Boston Scientific’s Interventional Cardiology division, said in the statement. “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.”
In the medicated stent, both the drug coating and the polymer – which modulates drug release – are fully absorbed shortly after the medication period is complete at three months.
According to Boston Scientific, in existing DES devices, the polymer remains on the stent after the drug is delivered. But long-term exposure to the polymer may cause inflammation, which delays healing and has been associated with complications, the company said. The SYNERGY Stent, therefore, allows for faster and sustained healing by eliminating long-term polymer exposure, the statement said.
