The FDA has approved under a Humanitarian Device Exemption the first single-access percutaneous ventricular assist device for right heart support, according to a press release issued by Abiomed.
The percutaneous VAD (Impella RP System) is indicated for providing circulatory assistance for up to 14 days in pediatric or adult patients with acute right HF or decompensation following left VAD implantation, MI, heart transplant or open-heart surgery, according to the release.
The device is designed to provide flow and pressure needed to compensate for right HF and provides up to 4 L/min of hemodynamic support, according to the release. It is delivered via a catheter through the femoral artery.
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.
A Humanitarian Use Device is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year, according to the FDA. 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.