FDA Approves Abiomed's Impella RP System for Right Heart Failure
September 20, 2017—Abiomed, Inc. announced that it has received US Food and Drug Administration (FDA) premarket approval (PMA) for the Impella RP heart pump. The percutaneous Impella RP system is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥ 1.5 m2, who develop acute right heart failure or decompensation after 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, noted the company.
Abiomed advised that it will conduct a postapproval study with 60 consecutive patients in Abiomed's prospective cVAD Registry.
The Impella RP heart pump stabilizes the patient's hemodynamics, unloads the right ventricle, and allows for native heart recovery. Delivered through a transfemoral catheter, the Impella RP heart pump is designed to provide the flow and pressure needed to compensate for right heart failure. The device provides more than 4 L of blood per minute for hemodynamic support.
According to Abiomed, data submitted to the FDA in support of the Impella RP heart pump PMA included RECOVER RIGHT, a prospective, multicenter, single-arm study that commenced after the company received the FDA's investigational device exemption approval in November 2012, and concluded in 2014.
In addition, Abiomed completed a continuous access protocol study and a prospective, multicenter postapproval study. These data were presented in April at the 2017 Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation in San Diego, California. Also in April, the data were published by Mark B. Anderson, MD, et al in The Journal of Heart and Lung Transplantation (2017;36:S64-S65).
Dr. Anderson, who served as the coprincipal investigator for the RECOVER RIGHT trial, commented in Abiomed's announcement, "The Impella RP has opened up a new era in cardiovascular medicine. With its percutaneous, single vascular access, the Impella RP offers physicians a minimally invasive procedure for patients who have previously had limited options for treatment of right heart failure. The cumulative data from the FDA studies demonstrate that Impella RP potentially offers survival benefits for these critically ill patients in need of hemodynamic support."