FDA Approves HDE for Abiomed's Impella RP Single-Access Heart Pump

January 27, 2015—Abiomed Inc. announced that the Impella RP (right percutaneous) system has received US Food and Drug Administration (FDA) approval under a humanitarian device exemption (HDE). The percutaneous Impella RP device is a single access heart pump designed for right heart support. Abiomed completed the HDE submission for the Impella RP in September 2014 after the completion of the RECOVER RIGHT study.

The company advised that it will conduct a controlled launch of the Impella RP in the United States after each provider site completes in-house training at Abiomed. This training will incorporate members of the heart team, including the interventional cardiologist, cardiac surgeon, heart failure cardiologist, and lead nurse.

Mark Anderson, MD, who served as coprincipal investigator for the RECOVER RIGHT trial, commented in the company’s press release, “The Impella RP represents a huge step forward in offering right side support using a minimally invasive platform and has the potential to transform interventional cardiology and cardiac surgery today. With the ability to place this device percutaneously on the right side, physicians can now treat acute right sided heart failure minimally invasively and quickly.” Dr. Anderson is Chair of the Division of Cardiothoracic Surgery at Einstein Medical Center in Philadelphia, Pennsylvania.

Delivered transfemorally, the Impella RP is FDA indicated for providing circulatory assistance for up to 14 days in pediatric or adult patients 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 is designed to provide the flow and pressure needed to compensate for right heart failure. The device provides up to 4 liters per minute of hemodynamic support.

As part of the HDE approval, Abiomed is required to conduct two postapproval studies for the RECOVER RIGHT trial. One trial will enroll 30 adult patients, and the other trial will enroll up to 15 pediatric patients (larger patients < 18 years of age with right ventricular failure [RVF]). These studies will be conducted to monitor the postmarket safety and probable benefit of the Impella RP device. Both studies will be single-arm multicenter studies that will follow the respective patients at 30 and 180 days after explantation of the device.

According to the company, the RECOVER RIGHT trial was an FDA-approved, prospective, multicenter, single-arm study designed to evaluate the safety and probable benefit of the Impella RP in patients with RVF refractory to medical treatment and deemed to require hemodynamic support. The trial enrolled 30 patients who were placed in two patient cohorts. Cohort A included patients who developed RVF within 48 hours after implantation of a left ventricular assist device. Cohort B examined patients who developed RVF within 48 hours of postcardiotomy shock or postacute myocardial infarction shock. The primary endpoint was patient survival at 30 days, hospital discharge, or bridge to the next therapy.

The clinical trial results from RECOVER RIGHT were announced in October 2014 at TCT 2014: the 26th annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC. Overall, the survival rate was 73% in the entire population at 30 days. Cohort A showed a survival rate of 83.3%, and Cohort B showed a 58.3% survival rate at 30 days, reported the company.

In May 2014, Abiomed announced FDA approval for a Continuous Access Protocol for RECOVER RIGHT.