FDA Approves Impella Pump for Right Heart Support

Disclosures

January 28, 2015

DANVERS, MA — The US Food and Drug Administration (FDA) has approved a percutaneous vascular-access pump for patients with right ventricular heart failure or decompensation[1].

Abiomed, the maker of the Impella Right Percutaneous (RP) System, announced this week that the agency granted the approval under a humanitarian device exemption (HDE). The FDA indication states the Impella device can provide circulatory support for up to 14 days in pediatric or adult patients with acute right heart failure or decompensation following the implantation of a left ventricular assist device (LVAD), MI, heart transplant, or open-heart surgery.

The approval is based on data from the RECOVER-RIGHT study, a prospective, multicenter trial testing the device in patients with right ventricular failure refractory to medical therapy and in need of hemodynamic support.

In RECOVER-RIGHT, investigators studied two cohorts: cohort A included patients with right ventricular failure within 48 hours after the implantation of an LVAD, while cohort B included patients who developed right ventricular failure within 48 hours of postcardiotomy shock or post–acute-MI shock. Presented at TCT 2014 by Dr William O'Neill (Henry Ford Hospital, Detroit, MI), the results showed that 83.3% and 58.3% of cohorts A and B, respectively, were alive at 30 days.

HDE approvals are exempt from the effectiveness requirements of a typical premarket approval (PMA), as they are intended to treat conditions that affect no more than 4000 individuals in the US each year. While they are exempt from efficacy requirements, the company must show the device is safe and that the likely benefit to health outweighs the risks.

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