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Abiomed's Impella RP With SmartAssist Gets FDA Pre-market Approval To Treat Right Heart Failure

Abiomed Inc. (ABMD), on Tuesday, announced that its newest right heart pump, the Impella RP with SmartAssist, has received U.S. Food and Drug Administration pre-market approval or 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 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 or EUA for Impella RP as a treatment for patients suffering from COVID-19-related right heart failure or decompensation, including pulmonary embolism (PE).

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.

Further, the company noted that Impella RP with SmartAssist would be introduced in the United States through a controlled rollout at hospitals that follow cardiogenic shock best practice protocols.

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