FDA Panel Gives Positive Review of Abbott Vascular's Absorb Bioresorbable Stent

March 15, 2016—Abbott Vascular announced that the Circulatory System Devices Panel of the Medical Devices Advisory Committee of the US Food and Drug Administration (FDA) voted 9 to 0, with one abstention, that the benefits of Abbott’s Absorb fully bioresorbable drug-eluting coronary stent outweigh the risks. 

The FDA panel also voted on the device's safety and efficacy as a treatment for coronary artery disease. On the question of whether there is reasonable assurance that the device is safe, the vote was 9 to 1 in favor. On the question of whether there is reasonable assurance that the device is efficacious, the vote was 10 to 0 in favor.

In mid-2015, Abbott Vascular submitted its premarket approval (PMA) application for the Absorb dissolving stent to the FDA. The advisory committee panel was convened to hear and review expert advice on the device’s clinical safety, efficacy, risk, and benefit. The FDA’s decision on Abbott’s PMA for the Absorb dissolving stent is expected later this year.

According to Abbott Vascular, the FDA advisory committee panel reviewed data from multiple studies of the Absorb device, including the company-sponsored ABSORB III, the United States clinical trial involving approximately 2,000 people that found the investigational device to be comparable to Abbott’s Xience drug-eluting metallic stent. 

At 1 year in ABSORB III, patients who received an Absorb stent had experienced comparable rates of specific adverse events—including target lesion failure—as compared to patients who received the Xience stent. The 1-year ABSORB III data were presented in October at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium, and published by Stephen G. Ellis, MD, et al in The New England Journal of Medicine (2015;373:1905–1915).

Gregg W. Stone, MD, who serves as chairman of the ABSORB clinical trial program, commented in the company’s announcement, “In multiple randomized clinical trials, the Absorb bioresorbable vascular scaffold has demonstrated comparable outcomes to the leading permanent metallic stent. As a first-in-kind device with novel properties, including complete dissolution and natural restoration of vessel function, this is a remarkable achievement. The available evidence supports an important role for this innovative device in the treatment of coronary artery disease.” Dr. Stone is Director of Cardiovascular Research and Education for the Center for Interventional Vascular Therapy at Columbia University Medical Center, New York-Presbyterian Hospital in New York, New York.