Abiomed (Nasdaq:ABMD) announced today that the FDA granted its Impella RP Flex with SmartAssist pre-market approval (PMA).
Danvers, Massachusetts-based Abiomed designed the Impella RP Flex with SmartAssist to treat right heart failure. It does so for up to 14 days. The company intends to introduce Impella RP Flex in the U.S. through a controlled launch this quarter.
The FDA indicated Impella RP Flex with SmartAssist for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2. These patients develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
Patients receive the Impella RP Flex via implant into the internal jugular (IJ) vein. This enables patient mobility, according to a news release. The heart pump also features dual-sensor technology for optimizing patient management, Abiomed said.
Impella RP includes the world’s smallest percutaneous right heart mechanical circulatory support (MCS) technologies, Abiomed said. The company designed these technologies to help patients achieve native heart recovery. They don’t require extracorporeal blood circulation.
Abiomed said its MCS technologies represent the only such offerings with FDA PMA indications for treating right heart failure.
“Impella RP Flex demonstrates Abiomed’s ongoing commitment to improving patient survival and achieving native heart recovery,” said Dr. Mark B. Anderson, chair of the department of cardiac surgery and cardiothoracic surgeon at the Heart and Vascular Hospital at HUMC/Hackensack Meridian Health.
About Impella RP Flex with SmartAssist
Impella RP Flex features single venous access through the IJ vein with an 11 French (Fr) indwelling catheter. This facilitates patient mobility, Abiomed said.
Additionally, it designed the platform with a flexible cannula advanced over an extra-support guidewire. The company said it enables both ease of insertion and pump delivery.
The SmartAssist dual-sensor technology combines with Impella Connect to deliver advanced metrics for pump management and weaning. Abiomed also developed a heparin-free purge to simplify patient anticoagulant management. Sodium bicarbonate is used where heparin is of concern due to heparin intolerance or bleeding.
Study data demonstrated a significantly higher survival rate in those who received Impella RP support compared to those who received delayed right-heart support. Within 48 hours of cardiogenic shock onset, Impella RP patients registered a 73% survival rate. Those who received delayed support survived at just a 14% clip.
“The complexity of right ventricular failure has resulted in patients being underdiagnosed and undertreated,” said Dr. Robert Salazar, an interventional cardiologist and director of cardiovascular research at Kingwood Medical Center. “Impella RP Flex is a novel tool that gives physicians the flexibility to treat this challenging patient population.”