FDA Okays Abiomed's Impella Heart Pump for Right Heart Failure

Megan Brooks

September 21, 2017

DANVERS, MA — The US Food and Drug Administration (FDA) has given premarket approval (PMA) to the Impella RP heart pump (Abiomed) for right heart failure, the device maker announced[1].

"With this approval, the Impella RP heart pump is the only percutaneous temporary ventricular support device that is FDA approved as safe and effective for right heart failure," the company says in a news release.

The Impella RP System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2 who develop acute right heart failure or decompensation following left ventricular assist device implantation, MI, heart transplant, or open-heart surgery.

Right ventricular failure (RVF) is associated with increased morbidity and mortality. "The Impella RP heart is designed to provide the flow and pressure needed to compensate for right heart failure. The device does not require a surgical procedure for insertion, and it provides more than 4 L of blood per minute for hemodynamic support," the company notes.

The safety and efficacy of the Impella RP heart pump was shown in the RECOVER RIGHT prospective multicenter study involving 30 patients with RVF refractory to medical treatment.

In this cohort of patients with life-threatening RVF, the Impella RP device was "safe, easy to deploy, and reliably resulted in immediate hemodynamic benefit," the study team concluded[2].

"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," Dr Mark B Anderson (Hackensack University Medical Group, NJ), co–principal investigator for the RECOVER RIGHT trial, said in the news release. "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."

The approval of the Impella RP heart pump follows the FDA humanitarian device exemption (HDE), which Abiomed received in January 2015  and adds the Impella RP heart pump to Abiomed's platform of approved devices, including the Impella 2.5, Impella CP, Impella 5.0, and Impella LD heart pumps.

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