MAQUET Cardiovascular Announces U.S. Food and Drug Administration Panel Votes to Reclassify Intra-Aortic Balloon Pumps to a Class II Designation in Certain Indications

MAQUET Cardiovascular announced that the Circulatory System Devices Panel of the U.S. Food and Drug Administration (FDA) recently voted to support the Agency’s reclassification of intra-aortic balloon pump (IABP) devices for certain indications to Class II (general controls and special controls) from Class III (general controls and pre-market approval). Those 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 non-ischemic etiologies, and cardiac and non-cardiac surgery.

According to the FDA and its panel of physicians and representatives, this recommendation was based on 40 years of extensive clinical experience and extensive literature, which support the hemodynamic effects and the devices’ safety and effectiveness in the aforementioned patient populations.

The FDA classifies medical devices using three designations, with Class III requiring the most stringent regulations — including premarket approval — for assuring 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.

The panel, which met on December 5–6, 2012, in Gaithersburg, Md., 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.

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