FDA Approves First Absorbable Stent for CAD
The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS) is absorbed by the body after about 3 years.
(HealthDay News) -- The first coronary stent to be gradually absorbed by the body has been approved by the US Food and Drug Administration.
The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS) is absorbed within about 3 years, the agency said Tuesday in a news release. The stent also releases the drug everolimus to limit the growth of scar tissue.
The newly approved stent is made from a biodegradable polymer called poly(L-lactide), which is similar to materials used in other types of absorbable medical devices, the agency noted. In this case, the device's absorption rids the affected artery of foreign material once it's no longer necessary, the FDA said. Once the product disintegrates, 4 platinum markers are left to indicate where the stent had been implanted.
The product was evaluated in a clinical study involving 2008 people. The major cardiac adverse event rate in the Absorb GT1 BVS group was 7.8%, which was deemed clinically comparable to the rate observed in the control group (6.1%). The rate of blood clots forming within the devices was 1.54% for the Absorb GT1 BVS and 0.74% for the control, according to the FDA.
The new stent is produced by Santa Clara, California-based Abbott Vascular.