Heart pump authorized for emergency use for right HF, decompensation from COVID-19
Abiomed announced that the FDA issued an emergency use authorization for a temporary heart pump for patients with COVID-19 with right HF or decompensation including pulmonary embolism.
The emergency use authorization indicates that the heart pump (Impella RP) can be used in the hospital for temporary right ventricular support for up to 14 days for the treatment of patients with acute right HF or decompensation associated with COVID-19 complications, according to a press release from the company.
“Based on extrapolation of data from the approved indication and reported clinical experience, FDA has concluded that the Impella RP may be effective at providing temporary right ventricular support for the treatment of acute right heart failure or decompensation caused by COVID-19 complications including pulmonary embolism,” according to the FDA authorization letter.
The heart pump was approved by the FDA in 2017 to provide circulatory support for patients with right-side ventricular failure who had an acute MI after cardiac surgery, according to the press release from the company.
“Impella RP is an important tool to help cardiologists save lives during this pandemic,” Amir Kaki, MD, interventional cardiologist and director of mechanical circulatory support at Ascension St. John Hospital in Detroit, said in the release. “As we have demonstrated in our series of patients, early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be lifesaving.”
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