Abiomed has received pre-market approval (PMA) from the US Food and Drug Administration (FDA) for its Impella RP heart pump.
The approval indicates the pump as a safe and effective percutaneous temporary ventricular support device for the failure of the right heart.
Impella RP can be used to provide right ventricular support temporarily for around 14 days in patients with a body surface area of equal to or greater than 1.5m².
The device is for patients with acute right heart failure or decompensation after implantation of a left ventricular assist device, myocardial infarction, heart transplant, or open-heart surgery.
It stabilises hemodynamics by delivering more than four litres of blood per minute and unloading the right ventricle to allow natural heart recovery.
Designed to offer the flow and pressure required for compensation of right heart failure, the pump does not need a surgical procedure and can be inserted through a catheter with a small hole in the leg.
Abiomed president, chairman and CEO Michael Minogue said: "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.
“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 FDA approval is based on the data obtained from the prospective, multi-centre, single-arm RECOVER RIGHT study performed between 2012-2014.
A Continuous Access Protocol (CAP) and a prospective, multi-centre post-approval study (PAS) has also been conducted by the firm, with plans for a PMA post-approval study in 60 patients.