FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs / Submissions and Approvals / Research and Development

Abiomed Completes Enrollment in RECOVER RIGHT Trial of Impella RP

March 24, 2014

Abiomed has completed initial enrollment in its multicenter RECOVER RIGHT clinical trial of the Impella RP percutaneous heart pump.

The study, conducted under an FDA investigational device exemption, is evaluating the device in 30 patients with right side heart failure that required hemodynamic support and was treated in a catheterization lab, hybrid lab or cardiac surgery suite. The trial design provides for up to two weeks of circulatory support.

The primary outcome measure is survival at 30 days or hospital discharge, whichever is longer post device explant or to the next therapy. Subsequent therapies may include heart transplant, bridge to transplant or destination therapy with an FDA-approved surgical ventricular assist device.

Abiomed plans to compile data from the study to support a continuous access protocol, which would allow for additional enrollees who meet the trial criteria.

Impella RP is the latest in Abiomed’s line of Impella heart pumps. Impella 2.5, Impella 5.0, Impella CP and Impella LD have already secured FDA premarket approval. In December 2012, an FDA advisory panel voted not to downclassify Impella from Class III to Class II. — Lena Freund

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.