FDA Devices Panel Recommends Reclassification of Intra-Aortic Balloon Pumps

December 13, 2012—Maquet Cardiovascular (Wayne, NJ) announced that the Circulatory System Devices Panel of the US Food and Drug Administration (FDA) voted to support the reclassification of intra-aortic balloon pump (IABP) devices for certain indications from class III (general controls and premarket approval) to class II (general controls and special controls). The panel met on December 5–6, 2012, in Gaithersburg, Maryland.

Maquet's announcement advised that the indications that received a recommendation to be reclassified to a class II designation include acute coronary syndrome, complications of heart failure of both ischemic and nonischemic etiologies, and cardiac and noncardiac surgery. Maquet makes and distributes a variety of IABP catheters and pumps, including the Sensation, Sensation Plus, Mega, and Linear product lines of IAB catheters, as well as the recently launched Cardiosave IABP. The panel also recommended that IABPs retain a class III designation for the treatment of septic shock and intraoperative pulsatile flow generation, indications for which the devices are less commonly used.
 

Maquet advised that the FDA classifies medical devices using three designations, with class III requiring the most stringent regulations—including premarket approval—for ensuring the safety and effectiveness of devices. The Circulatory System Devices Panel provides the FDA with independent expert advice and recommendations; however, the final decision regarding class designations is made by the FDA, noted Maquet.