Abiomed’s Impella RP With SmartAssist Approved by FDA to Treat Right Heart Failure

June 29, 2021—Abiomed announced that its Impella RP with SmartAssist has received FDA premarket approval (PMA) as safe and effective to treat acute right heart failure for up to 14 days.

As noted in the company announcement, the FDA indication for use of Impella RP 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 with SmartAssist will be introduced in the United States through a controlled rollout at hospitals that follow cardiogenic shock best practice protocols, advised Abiomed.

According to the company, Impella RP with SmartAssist is a single-access temporary percutaneous ventricular support device with dual-sensor technology that provides real-time guidance and trends to help with pump management and weaning. The system is enhanced with Impella Connect, Abiomed’s online device management system that enables remote monitoring from any internet-connected device through a secure, HIPAA-compliant website.

Impella RP with SmartAssist builds on the Impella RP, which received PMA by the FDA in 2017 to treat patients with right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

“Impella RP with SmartAssist further improves an incredibly valuable tool to treat right heart dysfunction,” commented Robert Salazar, MD, in Abiomed’s press release. “The addition of SmartAssist technology to Impella RP is an important advancement to help physicians achieve even better patient outcomes with an improved design and intuitive metrics.” Dr. Salazar is an interventional cardiologist at Memorial Hermann Health System Northeast Hospital in Humble, Texas, and Kingwood Medical Center in Kingwood, Texas.

Nishant Patel, MD, added, “Early detection of right heart failure and early action is key to improving patient survival rates. Data demonstrates that Impella RP dramatically improves survival rates for critically ill patients in need of right heart hemodynamic support. I look forward to improving outcomes further with this new generation of Impella RP.” Dr. Patel is a cardiothoracic surgeon at Palm Beach Gardens Medical Center in Palm Beach Gardens, Florida.