Abiomed receives FDA PMA approval for Impella RP for right heart failure
Abiomed has received FDA pre-market approval for the Impella RP heart pump. This approval follows the prior FDA Humanitarian Device Exemption received in January 2015 and adds the Impella RP heart pump to Abiomed's platform of PMA approved devices. The Impella RP System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area greater than or equal to1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. The Impella RP heart pump is reimbursed by Medicare and other major payers. Abiomed will complete a PMA post-approval study with 60 consecutive patients in Abiomed's Institutional Review Board-approved, FDA audited prospective cVAD Registry.