Absorbable Stent Approved for Coronary Heart Disease Treatment
Coronary heart disease kills about 370,000 Americans each year, according to the National Heart, Lung, and Blood Institute.
The U.S. Food and Drug Administration on July 5 approved the first fully absorbable stent to treat coronary artery disease. The Absorb GT1 Bioresorbable Vascular Scaffold System releases the drug everolimus to limit the growth of scar tissue and is gradually absorbed by the body in approximately three years, the agency announced. The Absorb GT1 BVS is manufactured by Abbott Vascular in Santa Clara, Calif.
"The FDA's approval of the Absorb GT1 BVS offers a new treatment option for individuals who are candidates for angioplasty but would prefer an absorbable device rather than a permanent metallic coronary stent," said Dr. Bram Zuckerman, M.D., director of the division of cardiovascular devices at FDA's Center for Devices and Radiological Health.
Coronary heart disease kills about 370,000 Americans each year, according to the National Heart, Lung, and Blood Institute.
The Absorb GT1 BVS is manufactured from a biodegradable polymer called poly(L-lactide), which resembles materials used in other types of absorbable medical devices, such as sutures. After the device is absorbed, only four small platinum markers are embedded in the walls of the artery, which help cardiologists identify where the Absorb GT1 BVS was originally placed.
In approving the product, FDA evaluated data from a randomized trial of 2,008 patients. After a year, the Absorb GT1 BVS group showed a major cardiac adverse event rate of 7.8 percent, which was clinically comparable to the rate of 6.1 percent observed in the control group. The rate of blood clots forming within the devices was 1.54 percent for the Absorb GT1 BVS and 0.74 percent rate for the control.