FDA Advisory Panel Recommends Approval of Absorb BVS
An advisory panel to the U.S. Food and Drug Administration (FDA) voted nearly unanimously on March 15 to recommend approval of Abbott International’s Absorb bioresorbable vascular scaffold (BVS) as a safe and effective treatment for patients with coronary artery disease. The Absorb BVS is an alternative treatment to permanent metal stent implants.
The recommendation from the panel is based on the results of the ABSORB clinical trials, which have examined the efficacy and non-inferiority of the Absorb BVS compared to mental stents. The full FDA decision will most likely be released in the coming months.
In a recent editorial comment in the Journal of the American College of Cardiology, David R. Holmes Jr., MD, MACC, past-president of the ACC, and Michael J. Mack, MD, FACC, a member of ACC’s Board of Trustees, discuss the role of BVS in interventional cardiology. Holmes and Mack emphasize that the Absorb BVS did not show superiority to metal stents in clinical trial. They add that “’here today, gone tomorrow’ remains an incredibly intriguing concept that still needs further development and follow-up to reach its full potential.”
Keywords: Coronary Artery Disease, Stents, United States Food and Drug Administration, Angiography
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