Right-side heart pump receives FDA premarket approval

The FDA announced the premarket approval of a right-side heart pump designed to treat patients with acute HF or decompensation following left ventricular assist device implantation, MI, heart transplant or open-heart surgery.

According to a press release, the Impella RP heart pump (Abiomed Inc.) is the only percutaneous temporary ventricular support device deemed safe and effective by the FDA in the treatment for right HF.

Since the conclusion of the RECOVER RIGHT prospective, multicenter, single-arm study in 2014, Abiomed has completed a continuous access protocol and a prospective, multicenter postapproval study.

Right ventricular failure has been linked to higher mortality rates, longer lengths of stay in the ICU and potential end-organ dysfunction, according to the release.

The release states that the Impella RP heart pump stabilizes the patient's hemodynamics, unloads the right ventricle and allows for native heart recovery. The Impella RP is delivered through a catheter through a small hold in the leg to provide the flow and pressure needed to compensate for right HF. Additionally, the device does not require a surgical procedure for insertion, and provides more than 4 L of blood per minute for hemodynamic support.

"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," Mark B. Anderson, MD, FASC, co-principal investigator for the RECOVER RIGHT trial and vice chair of cardiac surgery services and cardiothoracic surgeon to the Hackensack University Medical Group, said in the 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."

Disclosure: Cardiology Today’s Intervention could not obtain disclosure information before publication.