FDA gives pre-market approval for Impella RP heart pump for right heart failure.- Abiomed.

Abiomed announced it has received FDA pre-market approval (PMA) for the Impella RP heart pump for right heart failure. This approval follows the prior FDA Humanitarian Device Exemption (HDE) 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 of at least 1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

Data submitted to the FDA in support of the Impella RP heart pump PMA included the RECOVER RIGHT1 FDA-approved, prospective, multicenter, single-arm study, which commenced after the company received FDA investigational device exemption (IDE) approval in November 2012 and concluded in 2014. Since that time, Abiomed completed a Continuous Access Protocol (CAP) as well as a prospective, multicenter post-approval study (PAS). These data was presented in the plenary session of the 2017 Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation.

Comment: Abiomed will now complete a PMA post-approval study with 60 consecutive patients in Abiomed's Institutional Review Board (IRB)-approved, FDA audited prospective cVAD Registry.