Heart pump nets FDA premarket approval for treatment of acute right HF
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Abiomed announced its right heart pump has received FDA premarket to treat acute right HF for up to 14 days.
According to a press release, the right heart pump (Impella RP with SmartAssist) is a single-access temporary percutaneous ventricular support device with dual-sensor technology.
The right heart pump is indicated for temporary right ventricular support for up to 14 days in patients with a body surface area of 1.5 m2 or more who develop acute right HF or decompensated HF following left ventricular assist device implantation, MI, heart transplant or open-heart surgery.
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.
According to the release, the new pump provides real-time guidance and trends to help with pump management and weaning; is designed for a simplified setup and insertion; and can be used with remote monitoring technology (Impella Connect).
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