FDA Panel Balks at TriGUARD 3 Cerebral Embolic Device for TAVR medscape.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from medscape.com Daily Mail and Mail on Sunday newspapers.
OCS Heart System Earns Hard-Won Backing of FDA Panel medscape.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from medscape.com Daily Mail and Mail on Sunday newspapers.
February 18, 2021
Despite having no significant safety concerns, an advisory panel to the US Food and Drug Administration said yesterday that it could not find enough evidence of efficacy and benefit to recommend premarket approval (PMA) of a below-the-knee drug-coated balloon (DCB) for the treatment of PAD.
After a full day of discussion, the Circulatory Devices Panel of the Medical Devices Advisory Committee
voted 15-2 (with one member abstaining) that reasonable assurance of safety was demonstrated for the DCB, made by Lutonix, a subsidiary of Becton, Dickinson and Company (BD).
On the question of reasonable assurance of efficacy, however, the vote was the same 15-2 (with one member abstaining) that efficacy was not demonstrated. Similarly, on the question of whether the panel believed that the benefits outweighed the risks, the vote was 14-3 (with one member abstaining) that they did not.