Federal regulators have approved new type of stent material that is designed to dissolve more quickly when used in the non-invasive coronary procedure that an estimated half-to-one million Americans undergo each year.
The new stent system, which was developed by Boston Scientific, is the first to use a new type of bioabsorbable-polymer material, which is designed to break down more quickly, the company said in announcing the U.S. Food and Drug Administration’s approval today.
Unlike traditional DES with a polymer that remains, Synergy's bioabsorbable polymer breaks down and is fully absorbed within three months the drug is released. This is unlike other stents with bioabsorbable polymers, which in general are fully absorbed within eight to nine months.
Stents coated with materials that dissolve more quickly are considered preferable because exposure to the material can cause inflammation, which delays healing and has been linked with complications, including blood clots.
The FDA approved the stent based on data from EVOLVE II, a study presented at the American Heart Association’s 2014 Scientific Sessions.
Angioplasty is the non-invasive procedure that opens coronary arteries, and drug-eluting stents are specially created to release medication to prevent the coronary artery from reclosing.