Therapy Areas: Cardiovascular
FDA Issues Emergency Use Authorization for Impella RP as Therapy for COVID-19 Patients with Right Heart Failure
1 June 2020 - - The United States Food and Drug Administration has issued an emergency use authorization for Impella RP to include patients suffering from COVID-19 related right heart failure or decompensation, including pulmonary embolism. 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 catheterisation laboratory or operating room.

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.
Drs. Schreiber and Kaki quickly placed an Impella RP and observed what they describe as a "dramatic and immediate" improvement in arterial pressure.

Over the next five days, the Impella RP remained in place and the patient was monitored remotely using cloud-based Impella Connect technology. On the fifth day, Impella RP was removed. The patient was later discharged home with her native heart.

This case has been highlighted in the American College of Cardiology educational programming on COVID-19 and can be reviewed online.

Published academic research presented to the FDA that demonstrates the feasibility of Impella RP to improve right ventricular function in patients with pulmonary embolism includes:

Zuin, et al., Europe PMC, 2019 This review of the treatment of pulmonary embolism using Impella RP concludes, "reviewed manuscripts demonstrated a significant hemodynamic improvement with a concomitant reduction of the right ventricle afterload in all patients which exhibit a low mortality rate in the short-term period."

Elder, et al., Journal of Interventional Cardiology, 2018 This study, reviewing the largest experience of pulmonary embolism patients treated with Impella RP concludes, use of Impella RP in patients with pulmonary embolism and right ventricular failure might improve hemodynamics and facilitate a bridge-to-recovery.

Bhatia, et al, Catherization and Cardiovascular Interventions, 2017 A case review of a 47-year-old man with a massive pulmonary embolism supported with Impella RP for 48 hours.

Impella support resulted in immediate increase in mean arterial pressure and decreased vasopressor requirements. The patient was discharged in one week.

The Impella RP is US FDA approved to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, open-heart surgery.

Based in Danvers, Massachusetts, USA, Abiomed, Inc. is a provider of medical devices that provide circulatory support.
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