Sam Brusco, Associate Editor10.31.22
Abiomed has earned U.S. Food and Drug Administration (FDA) premarket approval (PMA) for its Impella RP Flex ith SmartAssist to treat acute right heart failure for up to 14 days.
Implanted via the internal jugular (IJ) vein to enable mobility, it has dual-sensor technology to optimize patient management. The Impella RP platform, according to Abiomed, includes the world’s smallest percutaneous right heart mechanical circulatory support (MCS) technologies to help achieve native heart recovery. They don’t requireextracorporeal blood circulation.
Impella RP Flex offers single venous access and 11 Fr indwelling catheter, with a flexible cannula over an extra-support guidewire. SmartAssist dual sensors with Impella Connect provides advanced metrics for pump management and weaning.
It also features a Heparin-free purge to simplify anticoagulant management with use of sodium bicarbonate where heparin is of concern.
“Impella RP Flex demonstrates Abiomed’s ongoing commitment to improving patient survival and achieving native heart recovery,” Mark B. Anderson, MD, chairman of the department of cardiac surgery and cardiothoracic surgeon at the Heart and Vascular Hospital at HUMC/Hackensack Meridian Health, told the press.
Impella RP Flex will be introduced in the U.S. in a controlled rollout this quarter.
Implanted via the internal jugular (IJ) vein to enable mobility, it has dual-sensor technology to optimize patient management. The Impella RP platform, according to Abiomed, includes the world’s smallest percutaneous right heart mechanical circulatory support (MCS) technologies to help achieve native heart recovery. They don’t requireextracorporeal blood circulation.
It also features a Heparin-free purge to simplify anticoagulant management with use of sodium bicarbonate where heparin is of concern.
“Impella RP Flex demonstrates Abiomed’s ongoing commitment to improving patient survival and achieving native heart recovery,” Mark B. Anderson, MD, chairman of the department of cardiac surgery and cardiothoracic surgeon at the Heart and Vascular Hospital at HUMC/Hackensack Meridian Health, told the press.
Impella RP Flex will be introduced in the U.S. in a controlled rollout this quarter.
