FDA grants approval for mechanical circulatory support device to treat acute right HF - Healio

Abiomed announced its percutaneous close bosom mechanical circulatory enactment instrumentality has received FDA premarket support for the attraction of acute close HF for up to 14 days.

The bosom pump instrumentality (Impella RP Flex with SmartAssist) is indicated for impermanent close ventricular enactment successful patients with a assemblage aboveground country 1.5 m² oregon more, who make acute close HF oregon decompensation pursuing near ventricular assistance instrumentality implantation, MI, bosom transplant oregon open-heart surgery, according to a property merchandise issued by the company.

Abiomed announced its percutaneous close bosom mechanical circulatory enactment instrumentality has received FDA premarket support for the attraction of acute close HF for up to 14 days.
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The pump is implanted via the jugular vein and an 11F indwelling catheter; does not necessitate extracorporeal humor circulation; and features dual-sensor exertion designed to optimize diligent management, according to the release.

As Healio antecedently reported, successful June 2020, the FDA issued an exigency usage authorization for an earlier mentation of the instrumentality arsenic a attraction for patients suffering from COVID-19-related close HF oregon decompensated HF, including pulmonary embolism.

“The complexity of close ventricular nonaccomplishment has resulted successful patients being underdiagnosed and undertreated,” Robert Salazar, MD, interventional cardiologist and manager of cardiovascular probe astatine Kingwood Medical Center, said successful the release. “Impella RP Flex is simply a caller instrumentality that gives physicians the flexibility to dainty this challenging diligent population.”