FDA approves Impella RP System for Heart Failure-Abiomed

The FDA has approved under a Humanitarian Device Exemption the Impella RP System, from Abiomed, the first single-access percutaneous ventricular assist device for right heart support. The approval was based on results from the RECOVER RIGHT study, in which 73% of patients with right ventricular failure refractory to medical therapy and requiring hemodynamic support who received the device met the primary endpoint of survival at 30 days, hospital discharge or bridge to the next therapy, according to the release.

As a condition of the FDA Humanitarian Device Exemption approval, Abiomed will conduct two postapproval studies. Both will be single-arm multicenter studies following patients up to 180 days post device explant; one will study adult patients and the other pediatric patients.