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June 30, 2021

Abiomed’s heart pump obtains US FDA pre-market approval 

With dual-sensor technology, this is the first single-access heart pump to deliver temporary percutaneous ventricular support.

The US Food and Drug Administration (FDA) has granted pre-market approval (PMA) to Abiomed’s latest heart pump, Impella RP with SmartAssist, for the treatment of acute right heart failure for up to 14 days.

The device is approved for treating patients with a body surface area greater than or equal to 1.5m² with acute right heart failure or decompensation after implanting a left ventricular assist device, myocardial infarction, heart transplant or open-heart surgery.

Impella RP with SmartAssist is the first single-access, dual-sensor technology device to provide temporary percutaneous ventricular support, the company noted.

Created with simple setup and insertion in mind, the device offers real-time assistance and trends to aid in pump management and weaning.

The device is augmented with Impella Connect for remote monitoring using any type of internet-connected device through a safe, Health Insurance Portability and Accountability Act-compliant website.

Impella RP with SmartAssist is an improvised version of Impella RP, which received PMA from the FDA in 2017.

The FDA issued an emergency use authorisation (EUA) for Impella RP to treat Covid-19 patients with right heart failure or decompensation, including pulmonary embolism, in June last year.

Early detection and treatment in people who need right heart support are vital as 37% of acute myocardial infarction cardiogenic shock patients have right heart dysfunction, which causes substantially high mortality risk.

An FDA PMA post-approval study showed that use of Impella RP within 48 hours of cardiogenic shock onset in right heart failure cases offers 73% survival versus 14% survival when placed after 48 hours.

Abiomed plans to launch Impella RP with SmartAssist in the US in a controlled manner at hospitals that maintain cardiogenic shock best practice protocols.

The development comes after the company received FDA investigational device exemption approval to begin a clinical trial for the Impella ECP heart pump in high-risk percutaneous coronary intervention patients.

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