FDA grants approval for mechanical circulatory support device to treat acute right HF
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Abiomed announced its percutaneous right heart mechanical circulatory support device has received FDA premarket approval for the treatment of acute right HF for up to 14 days.
The heart pump device (Impella RP Flex with SmartAssist) is indicated for temporary right ventricular support in patients with a body surface area 1.5 m2 or more, who develop acute right HF or decompensation following left ventricular assist device implantation, MI, heart transplant or open-heart surgery, according to a press release issued by the company.
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The pump is implanted via the jugular vein and an 11F indwelling catheter; does not require extracorporeal blood circulation; and features dual-sensor technology designed to optimize patient management, according to the release.
As Healio previously reported, in June 2020, the FDA issued an emergency use authorization for an earlier version of the device as a treatment for patients suffering from COVID-19-related right HF or decompensated HF, including pulmonary embolism.
“The complexity of right ventricular failure has resulted in patients being underdiagnosed and undertreated,” Robert Salazar, MD, interventional cardiologist and director of cardiovascular research at Kingwood Medical Center, said in the release. “Impella RP Flex is a novel tool that gives physicians the flexibility to treat this challenging patient population.”
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