January 29th, 2015
FDA Approves Right Percutaneous Single Access Heart Pump
Abiomed has announced that it received FDA approval for its Impella RP System, the first percutaneous single access heart pump that provides support to the right side of the heart. The approval, under a Humanitarian Device Exemption (HDE), is based on results of the single-arm Recover Right study, in which 30 patients were enrolled. The overall survival rate was 73% at 30 days.
The device is indicated to provide circulatory support for as long as 14 days to pediatric or adult patients with acute right heart failure or decompensation after implantation of an LVAD, MI, heart transplant, or open-heart surgery. The Impella RP provides up to four liters per minute of hemodynamic support, according to the company.
Abiomed said the device would undergo a “controlled launch” and would be available only after sites complete a rigorous training course involving the heart team from each institution, “including the interventional cardiologist, cardiac surgeon, heart failure cardiologist and lead nurse.”
The FDA is requiring Abiomed to perform post-approval studies in 30 adult patients and up to 15 pediatric patients. The single-arm studies will follow patients at 30 days and 180 days after device explant.
The Boston Globe reported that the company plans to initiate follow-up testing that could potentially significantly expand the patient population eligible to receive the device.