Abiomed’s Impella RP Flex with SmartAssist Is Approved by FDA to Treat Right Heart Failure

October 31, 2022—Abiomed announced that the Impella RP Flex with SmartAssist has received FDA premarket approval as a safe and effective treatment of acute right heart failure for up to 14 days. Impella RP Flex will be introduced in the United States through a controlled rollout in Q4 2022.

According to the company, the FDA indication for use of Impella RP Flex with SmartAssist is for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥ 1.5 m² 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 demonstrates Abiomed’s ongoing commitment to improving patient survival and achieving native heart recovery,” said Mark B. Anderson, MD, in the company’s press release. Dr. Anderson is chairman of the department of cardiac surgery and cardiothoracic surgeon at the Heart and Vascular Hospital at HUMC/Hackensack Meridian Health in Hackensack, New Jersey.

Robert Salazar, MD, added, “The complexity of right ventricular failure has resulted in patients being underdiagnosed and undertreated. Impella RP Flex is a novel tool that gives physicians the flexibility to treat this challenging patient population.” Dr. Salazar is an interventional cardiologist and director of cardiovascular research at Kingwood Medical Center in Houston, Texas.

The company stated that key the Impella RP Flex allows single venous access via the internal jugular vein with an 11-F indwelling catheter, thereby facilitating patient mobility. A flexible cannula advanced over an extra-support guidewire enables ease of insertion and pump delivery. The SmartAssist dual-sensor technology with Impella Connect provides advanced metrics to help with pump management and weaning. A heparin-free purge simplifies patient anticoagulant management with the use of sodium bicarbonate where heparin is of concern due to heparin intolerance or bleeding.

In June 2021, the company announced FDA approval of Impella RP with SmartAssist.