FDA panel votes to down-class intra-aortic balloon pumps for some uses
The FDA's Circulatory System Devices Panal votes to relax some regulatory burdens for intra-aortic balloon pump devices in certain cases.
The FDA's Circulatory System Devices Panel voted on Dec. 5 to reduce the regulatory burden for intra-aortic balloon pump (IABP) devices to Class II (special controls) for certain indications, while keeping the more stringent Class III premarket approval requirement in place for a few uses.
IABPs consist of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon, by FDA's definition. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.