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Impella RP with SmartAssist Receives FDA Pre-Market Approval (Photo: Business Wire)
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
“Impella RP with SmartAssist further improves an incredibly valuable tool to treat right heart dysfunction,” said
Impella RP with SmartAssist is:
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% 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% survival, compared to 14% 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
One patient who benefited from treatment with the first generation of Impella RP is
The FDA indication for use of Impella RP with SmartAssist is as follows:
The Impella RP with SmartAssist System is indicated 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
ABOUT IMPELLA HEART PUMPS
The Impella RP® and the Impella RP® with SmartAssist® System are
The Impella RP is also authorized for emergency use by healthcare providers (HCPs) in the hospital setting for providing temporary right ventricular support for up to 14 days in critical care patients with a body surface area ≥1.5 m², for the treatment of acute right heart failure or decompensation caused by complications related to coronavirus disease 2019 (COVID‐19), including pulmonary embolism (PE). The Impella RP has not been cleared or approved for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19. The Impella RP has been authorized for the above emergency use by FDA under an EUA and has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Any forward-looking statements are subject to risks and uncertainties such as those described in