Abiomed has announced that Impella RP Flex with SmartAssist has received US Food and Drug Administration (FDA) premarket approval (PMA), the FDA’s highest level of approval, as safe and effective to treat acute right heart failure for up to 14 days.
Impella RP Flex is implanted via the internal jugular (IJ) vein, which enables patient mobility, and has dual-sensor technology designed to optimise patient management, Abiomed said in a press release.
“Impella RP Flex demonstrates Abiomed’s ongoing commitment to improving patient survival and achieving native heart recovery,” said Mark B Anderson, chairman of the department of cardiac surgery and cardiothoracic surgeon at the Heart and Vascular Hospital at HUMC/Hackensack Meridian Health, Hackensack, USA.
Early identification of right heart failure or right ventricular dysfunction and early use of Impella RP is associated with significantly higher survival rates. Studies published in the Journal of Cardiac Failure and Journal of American College of Cardiology demonstrate that 37% of AMI cardiogenic shock (AMICS) patients exhibit right heart dysfunction and that right heart dysfunction is associated with three times increased risk of mortality. Data published in the Journal of Heart and Lung Transplantation shows patients who received Impella RP support within 48 hours of cardiogenic shock onset had a significantly higher survival rate than those who received delayed right-heart support (73% vs. 14%, p<0.001).
“The complexity of right ventricular failure has resulted in patients being underdiagnosed and undertreated,” said Robert Salazar (Kingwood Medical Center, Houston, USA). “Impella RP Flex is a novel tool that gives physicians the flexibility to treat this challenging patient population.”
The indication denotes that the Impella RP Flex with SmartAssist System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
Impella RP Flex will be introduced in the USA through a controlled rollout this quarter.