On Jan. 28, the U.S. Food and Drug Administration (FDA) approved Abiomed’s Impella Right Percutaneous System for patients with right ventricular heart failure or decompensation. The device can provide up to 14 days of circulatory support in pediatric or adult patients who have undergone the implantation of a left ventricular assist device, myocardial infarction, heart transplant or open-heart surgery. The device was approved under a humanitarian device exemption (HDE) as it treats conditions that affect less than 4,000 patients in the U.S. each year. Although the HDE exempts the device from efficacy requirements, the FDA requires Abiomed to show that the benefits of the device outweigh any risks.

Keywords: Adult, Cardiac Surgical Procedures, Child, Compassionate Use Trials, Heart Failure, Heart Transplantation, Heart-Assist Devices, Myocardial Infarction, Pediatrics, United States, United States Food and Drug Administration, Ventricular Dysfunction, Right

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