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FDA issues EUA for Abiomed Impella RP to treat COVID-19 heart failure

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Abiomed's Impella 5.5 heart pumpAbiomed (NSDQ:ABMD) announced that it received FDA emergency use authorization (EUA) for its Impella RP for use with COVID-19-related right heart failure.

The Impella RP temporary heart pump provides circulatory support for patients with right side ventricular failure. It won FDA approval in September 2017 for such an indication and in October 2019 Abiomed reported real-world data on the device that showed a survival rate matching that of its pre-approval study when following the FDA’s approved protocol.

During the COVID-19 pandemic, Impella RP has been used for treating right heart failure or decompensation, including pulmonary embolism, according to a news release. It can be deployed in minutes using a minimally invasive technique.

The FDA granted EUA based on data from Impella RP’s approved indication and reported clinical experience. Under the authorization, healthcare providers may use the device in a hospital setting when providing temporary right ventricular support for up to 14 days in critical care patients with a body surface area ≥1.5 m2 who are experiencing acute right heart failure or decompensation caused by complications related to COVID-19.

“Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19,” Ascension St. John Hospital (Detroit) interventional cardiologist & director of mechanical circulatory support Dr. Amir Kaki said in the news release. “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.”

Kaki and Dr. Ted Schreiber cited an example of a 59-year-old woman from the Detroit area who used Impella RP therapy after being diagnosed with COVID-19 and an acute pulmonary embolism. The doctors described a “dramatic and immediate” arterial pressure improvement in the patient.

The Impella RP remained in place over the next five days as carers monitored the patient using cloud-based Impella Connect technology. On the fifth day, the device was removed and the patient was discharged.

“We appreciate the work of physicians and healthcare providers to treat these difficult patients and thank the FDA for its emergency use authorization for Impella RP,” Abiomed chairman, president & CEO Michael Minogue said. “We are committed to helping our customers improve the outcomes of their patients with our percutaneous heart pumps during these COVID-19 times.”

Shares of ABMD were down -1% at $221.70 per share in mid-morning trading today.

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