FDA approves Absorb GT1 Bioresorbable Vascular Scaffold System for coronary artery disease- Abbott Vascular

The FDA has approved the Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), from Abbott Vascular, the first fully absorbable stent to treat coronary artery disease. The BVS releases the drug everolimus to limit the growth of scar tissue, is gradually absorbed by the body in approximately three years. In approving the Absorb GT1 BVS, the FDA evaluated data from a randomized trial of 2,008 patients, which compared the rate of major adverse cardiac events between the Absorb GT1 BVS and a drug-eluting metallic stent. After one 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.

In addition, after one year, 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. Possible adverse events that may be associated with the procedure to insert the Absorb GT1 BVS or with the Absorb GT1 BVS itself include allergic reactions to materials in the device or medications used during the procedure, allergic reaction to the drug everolimus, infection or irritation at the catheter insertion site, internal bleeding, the development of abnormal connections between arteries and veins, embolism, or other coronary artery complications that may require medical intervention and that could lead to death.