Abiomed’s newest right heart pump, the Impella RP with SmartAssist, received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) as safe and effective to treat acute right heart failure for up to 14 days.
 
Impella RP with SmartAssist is the first single-access temporary percutaneous ventricular support device with dual-sensor technology. Impella RP with SmartAssist is an innovative advancement of Impella RP, which was granted a PMA by the FDA in 2017 and has treated thousands of patients globally with right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. Additionally in June 2020, the FDA issued an emergency use authorization (EUA) for Impella RP as a treatment for patients suffering from COVID-19-related right heart failure or decompensation, including pulmonary embolism (PE).
 
“Impella RP with SmartAssist further improves an incredibly valuable tool to treat right heart dysfunction,” said Robert Salazar, MD, interventional cardiologist, Memorial Hermann Health System Northeast Hospital and Kingwood Medical Center. “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.”

Impella RP with SmartAssist is:
 

• The first dual-sensor technology heart pump, providing real-time guidance and trends to help with pump management and weaning
• Designed for a simplified setup and insertion
• Enhanced with Impella Connect to enable remote monitoring from any internet-connected device through a secure, HIPAA-compliant website
• SmartAssist technology is also available on Impella CP and Impella 5.5 for management of left heart failure and early identification of right heart failure.

 
Early identification and treatment of patients requiring right heart support is critical because, as demonstrated in Lala et al., 37 percent of acute myocardial infarction cardiogenic shock (AMICS) patients exhibit right heart dysfunction, which results in a significantly increased risk of mortality. When right heart failure is present, the use of Impella RP within 48 hours of cardiogenic shock onset leads to 73 percent survival, compared to 14 percent survival when implanted after 48 hours, according to a FDA PMA post-approval study presented at TCT Connect 2020.
 
“Early detection of right heart failure and early action is key to improving patient survival rates,” said Nishant Patel, MD, cardiothoracic surgeon at Palm Beach Gardens Medical Center. “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.”