FDA Approves First Fully Dissolvable Stent
TUESDAY, July 5, 2016 -- The first coronary stent to be gradually absorbed by the body has been approved by the U.S. Food and Drug Administration.
The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS) is absorbed within about three years, the agency said Tuesday in a news release. The stent, a hollow mesh tube designed to prop open a formerly clogged artery, also releases the drug everolimus to limit the growth of scar tissue.
Coronary artery disease leads to some 370,000 deaths annually in the United States, the FDA said. It occurs when cholesterol-laden deposits build up and narrow blood vessels, reducing blood flow to the heart. Symptoms commonly include chest pain, shortness of breath and fatigue. The condition is frequently treated using a procedure called angioplasty, in which a balloon-like device is expanded within an artery to open the vessel. But scar tissue can then form within the stent, leading to a re-narrowing of the artery.
The newly approved stent is made from a biodegradable polymer that's commonly used in medical devices designed to be absorbed by the body. 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, four platinum markers are left to show doctors where the stent had been implanted.
The product was evaluated in clinical studies involving more than 2,000 people. Compared to a standard metallic stent, the product was found statistically equally capable of reducing "major cardiac adverse events" and preventing the formation of blood clots within the device, the FDA said.
The new stent is produced by Santa Clara, Calif.-based Abbott Vascular.
To learn more, visit the FDA.
Posted: July 2016