FDA Approves First Fully Bioresorbable Stent for Treatment of CAD
The FDA and Abbott announced that the agency has approved the first fully bioresorbable stent indicated for patients with CAD.
The device (Absorb GT1 Bioresorbable Vascular Scaffold System, Abbott Vascular) limits the growth of scar tissue by releasing everolimus into the body and is gradually absorbed by the body over approximately 3 years, leaving behind four small platinum markers embedded in the arterial walls to help identify its prior location, according to press releases from the company and the agency.
“The FDA’s approval of the Absorb GT1 BVS offers a new treatment option for individuals who are candidates for [PCI], but would prefer an absorbable device rather than a permanent metallic coronary stent,” said Bram Zuckerman, MD, director of the division of cardiovascular devices at the FDA’s Center for Devices and Radiological Health.
Approval was based on the ABSORB III trial of 2,008 patients that compared short-term and mid-term outcomes of the bioresorbable vascular scaffold (BVS) to a metallic stent (Xience, Abbott Vascular). The BVS had similar rates of cardiac adverse events compared with the metallic stent (7.8% vs. 6.1%, respectively). The rate of device thrombosis at 1 year was slightly higher for the BVS (1.54% vs. 0.74%).
According to the FDA release, possible adverse events related to the use of the BVS include allergic reaction to poly(L-lactide), poly(D, L-lactide), platinum or the drug everolimus, as well as infection or internal bleeding.
Abbott is planning to first offer the device to centers that participated in the clinical trial program and eventually to all U.S. hospitals, according to the company release.
Gregg W. Stone, MD, FACC, FSCAI, director, cardiovascular research and education, Center for Interventional Vascular Therapy, NewYork-Presbyterian Hospital/Columbia University Medical Center, and chairman of the ABSORB clinical trial program, said in Abbott’s release that “No metal means the treated artery can pulse and flex naturally as demands on the heart change with everyday activities. No metal may also reduce the potential of future blockages that occur with permanent metallic stents, and allows easier access to other treatment options should they prove necessary in the patient’s future.”
Reference: Zuckerman is an employee of the FDA. Stone reports receiving consulting fees from Boston Scientific, Cardiovascular Systems Inc., Eli Lilly/Daiichi Sankyo, InfraReDx, InspireMD, Matrizyme, Miracor, Osprey, Reva, TherOx, Vascular Dynamics and Velomedix; and holding equity interest in Biostar, Cagent, Caliber, Guided Delivery Systems, MedFocus, Micardia, Qool Therapeutics and Vascular Nanotransfer.