Abiomed (NSDQ:ABMD) announced today that the FDA granted premarket approval (PMA) to its Impella RP with SmartAssist.
Danvers, Mass.-based Abiomed received PMA for the Impella RP right heart pump with SmartAssist as a safe and effective treatment for acute right heart failure for up to 14 days, according to a news release.
The company touts ImpellaRP with SmartAssist as the first single-access, temporary percutaneous ventricular support device with dual-sensor technology.
Dual-sensor technology offers real-time guidance and trends to help with pump management and weaning, the company said. Impella RP with SmartAssist also features a design for simplified setup and insertion and enhancements through Impella Connect, enabling remote monitoring from any internet-connected device through a secure, HIPAA-compliant website.
The FDA indicated for RP with SmartAssist under PMA for providing temporary right ventricular support for up to 14 days in patients with a body surface area of ≥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.
Abiomed plans to introduce Impella RP with SmartAssist throughout the U.S. in a controlled rollout at hospitals that follow cardiogenic shock best practice protocols.
“Impella RP with SmartAssist further improves an incredibly valuable tool to treat right heart dysfunction,” Memorial Hermann Health System Northeast Hospital & Kingwood Medical Center interventional cardiologist Dr. Robert Salazar said in the 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.”