FDA issues emergency use authorization for Impella RP as therapy for COVID-19 patients with right heart failure

FDA issues emergency use authorization for Impella RP as therapy for COVID-19 patients with right heart failure

Press releases may be edited for formatting or style | June 01, 2020 Cardiology
DANVERS, Mass.--(BUSINESS WIRE)--Jun. 1, 2020-- The United States Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Impella RP to include patients suffering from COVID-19 related right heart failure or decompensation, including pulmonary embolism (PE). Abiomed (NASDAQ: ABMD) manufactures Impella RP.

Impella RP is a temporary heart pump that provides circulatory support for patients who develop right side ventricular failure. Five years of pre- and post-market clinical studies support Impella RP’s safety and efficacy. In 2017, Impella RP received FDA approval as safe and effective for treating right ventricular failure in the setting of acute myocardial infarction and after cardiac surgery. Biventricular cardiac support can be provided when Impella RP is used in combination with left-side Impella devices.

Since the onset of the COVID-19 pandemic, Impella RP has become a therapeutic choice for clinicians treating certain COVID-19 patients suffering right heart failure. COVID-19 can create a prothrombotic environment in some patients resulting in acute pulmonary embolism which may lead to acute right ventricular failure. For critically ill patients the Impella RP can be rapidly deployed in a matter of minutes using a minimally invasive technique in the cardiac catheterization laboratory or operating room.

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In its authorization letter, the FDA writes, “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 PE.”

“Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19. Impella RP is an important tool to help cardiologists save lives during this pandemic. 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 life-saving,” said Amir Kaki, an interventional cardiologist and director of mechanical circulatory support at Ascension St. John Hospital in Detroit.

For example, a 59-year-old Detroit-area woman diagnosed with COVID-19 benefited from Impella RP therapy. Dr. Kaki and his colleague, Dr. Ted Schreiber diagnosed her with an acute pulmonary embolism. After the clot was removed, the patient went into right ventricular failure and became hypotensive.

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