The FDA granted Abiomed a Humanitarian Device Exemption for a percutaneous single-access heart pump for patients who develop right heart failure or decompensation.
The approval applies to the Impella RP System, which is designed to provide right heart support. Acute right heart failure or decompensation can occur after patients receive a left ventricular assist device (LVAD) implant, experience an MI, or undergo a heart transplant or open-heart surgery.
The Impella RP System assists with flow and pressure by providing up to four liters per minute of hemodynamic support. It can be used in pediatric and adult patients for up to 14 days.
The FDA based its approval on results from the RECOVER RIGHT trial, which evaluated the safety and probable benefit of the system in 30 patients with right ventricular failure. The patients either developed right ventricular failure within 48 hours after LVAD implantation or after cardiotomy shock or post-acute MI shock.
The overall survival rate was 73 percent at 30 days (83.3 percent in the LVAD group and 58.3 percent in the cardiotomy/post-acute MI shock group).
The FDA is requiring Danvers, Mass.-based Abiomed to conduct one post-approval study that enrolls at least 30 adult patients and one that enrolls at least 15 pediatric patients treated with the device.