September 28, 2017 — Abiomed Inc. recently received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the Impella RP heart pump. Culminating from five years of research, 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.
With this approval, the Impella RP heart pump is the only percutaneous temporary ventricular support device, according to Abiomed, that is FDA-approved as safe and effective for right heart failure as stated in the indication.
The 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 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 were presented in the plenary session of the 2017 Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation2. 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 (IRB)-approved, FDA-audited prospective cVAD Registry.
Right ventricular failure (RVF) is associated with increased mortality, longer lengths of stay in the intensive care unit and potential end-organ dysfunction1. The Impella RP heart pump stabilizes the patient's hemodynamics, unloads the right ventricle and allows for native heart recovery. Delivered through a catheter requiring only a small hole in the leg, the Impella RP heart pump is designed to provide the flow and pressure needed to compensate for right heart failure. The device does not require a surgical procedure for insertion, and it provides more than four liters of blood per minute for hemodynamic support.
"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," said Mark B. Anderson, M.D., FASC, co-principle investigator for the RECOVER RIGHT trial and vice chair of cardiac surgery services and cardiothoracic surgeon to the Hackensack University Medical Group. "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."
For more information: www.abiomed.com
1. Anderson MB, Goldstein J, Milano C, et al. Benefits of a novel percutaneous ventricular assist device for right heart failure: The prospective RECOVER RIGHT study of the Impella RP device. J Heart Lung Transplant. 2015; 34(12):1549-1560.
2. Anderson, MB, et al. Impella RP Post Approval Study: First Multi-Center, Prospective Post Market Approval Results for the Impella RP in Patients with Right Ventricular Failure. J Heart Lung Transplant. 2017; 36(4):S64-S65.