Maquet Cardiovascular (Wayne, New Jersey), a provider of intra-aortic balloon (IAB) therapy devices, reported this week that the Circulatory System Devices Panel of the 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. Read More
