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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

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 (ACC) educational programming on COVID-19 and can be reviewed online.

“This patient demonstrated a profound recovery after placement of Impella RP,” said Dr. Schreiber, who is chief of cardiology at Ascension St. John Macomb-Oakland Hospital and senior author of a 2018 academic review of pulmonary embolism patients treated with Impella RP. “In the course of 30 seconds, there was a dramatic and immediate hemodynamic response and the patient’s blood pressure markedly improved. This case demonstrates the efficacy and robustness of Impella RP in the setting of right ventricular failure.”

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“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. We are committed to helping our customers improve the outcomes of their patients with our percutaneous heart pumps during these COVID-19 times,” said Michael R. Minogue, Abiomed’s Chairman, President and Chief Executive Officer.

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 & 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.

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