First absorbable drug-emitting stent approved by FDA

The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS) was approved by the U.S. Food and Drug Administration (FDA) this week. 

This is the first drug-releasing, absorbable stent approved for use in coronary artery disease. It is manufactured by Abbott Vascular.

“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,” FDA Director of the Center for Devices and Radiological Health, Division of Cardiovascular Devices, Dr. Bram Zuckerman said.

Stents are used in coronary heart disease patients to widen the coronary artery and increase blood flow to the heart. In some cases, scar tissue forms within metal stents. The Absorb GT1 BVS slowly releases everolimus, which limits scar tissue growth, for a few months after implantation. Then the stent is absorbed by the body over approximately three years, leaving only four platinum markers behind.

The clinical trial evaluated by the FDA had 2,008 patients. It compared the Absorb GT1 BVS to a drug-eluting metal stent. The control group with the metal stent showed a 6.1 percent rate of major cardiac adverse events versus 7.8 percent in the Absorb GT1 BVS group, making them clinically comparable.