The first implant procedure using the Impella RP Flex (Abiomed) percutaneous pump, following its recent US Food and Drug Administration (FDA) premarket approval, was performed on 8 November.
Hackensack Meridian Hackensack University Medical Center cardiac surgeons Mark Anderson and Yuriy Dudiy carried out the first-in-human heart pump implantation. The procedure was performed to treat right heart failure during a valve replacement procedure.
Impella RP Flex received FDA premarket approval as being safe and effective to treat acute right heart failure for up to 14 days.
Impella RP Flex is used to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
“Impella RP Flex is a next-generation heart pump technology that can provide temporary right ventricular support for patients who experience right heart failure, allowing the heart to rest and recover,” said Anderson, who was involved in the initial research for Abiomed’s first right support device, Impella RP, for patients with right ventricular failure requiring short-term haemodynamic support.
“This technology is game-changing, because it provides cardiac surgeons with a new, minimally invasive alternative to surgically implanted right heart support devices that require opening the chest during an invasive sternotomy.”