FDA approves Abiomed’s Impella RP heart pump

Abiomed (NSDQ:ABMD) said today that it won pre-market approval from the FDA for its Impella RP heart pump, claiming it as the only such device cleared for right heart failure.

Like Abiomed’s flagship Impella heart pump, the Impella RP is threaded into the heart via the femoral artery in the thigh. But unlike previous Impella models, all designed for the heart’s left ventricle, the Impella RP is designed to access the heart’s right ventricle via the vena cava.

Danvers, Mass.-based Abiomed said the FDA indication is for Impella RP treatment for up to 14 days in patients with a body surface area of at least 1.5m². The federal safety watchdog granted a humanitarian device exemption in January 2015 for the Impella RP device.

“This latest PMA approval for Impella RP enables physicians for the first time to percutaneously treat a broader population of patients with right heart failure,” chairman, president & CEO Michael Minogue said in prepared remarks. “Abiomed would like to recognize the FDA as well as our physicians, scientists and employees for the extensive clinical research and review that allowed this FDA PMA approval. Abiomed now offers a platform of minimally-invasive devices that support both sides of the heart to enable heart recovery and we are committed to education and training for the entire heart team as we move to full commercial availability.”

“The Impella RP has opened up a new era in cardiovascular medicine. With its percutaneous, single vascular access, the Impella RP offers physicians a minimally-invasive procedure for patients who have previously had limited options for treatment of right heart failure,” added Dr. Mark Anderson, of the Hackensack University Medical Group and co-principal investigator for Abiomed’s Recover Right trial. “The cumulative data from the FDA studies demonstrate that Impella RP potentially offers survival benefits for these critically ill patients in need of hemodynamic support.”

Results from the Recover Right study showed an overall 73% 30-day survival rate. The trial enrolled patients into two cohorts: those who developed right ventricular failure within 48 hours of receiving a left ventricular assist device (Cohort A) and those that developed RVF within 48 hours of post-cardiotomy shock or post-acute myocardial infarction shock (Cohort B). The former fared better than the latter, with Cohort A patients showing a survival rate of 83.3% and Cohort B patients showing a survival rate of 58.3% at 30 days.

New of the FDA nod sent ABMD shares up 2.3% to $161.02 apiece today in pre-market trading.

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