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FDA issues emergency use authorization for Impella heart pumps to provide unloading therapy to COVID-19 patients

Press releases may be edited for formatting or style | August 04, 2020 Cardiology

“I’m so thankful for the physicians, nurses and staff who saved my life,” said Smith. “My recovery was made possible by their use of life-saving therapies, like Impella and ECMO, that allowed my body to overcome COVID-19.”

“As a community hospital, we are proud to offer patients initiation of advanced mechanical circulatory support treatment options. In this case, ECpella allowed us to support both his circulatory collapse and recurrent life-threatening arrhythmias, as a tertiary center helped treat the virus,” said Dr. Finley. “It is remarkable to see the patient return home with completely normal heart function, normal respiratory and renal function. This case is a testament to the capabilities of ECpella in the setting of severe COVID-19 infection and myocardial involvement. Without our advanced treatment offerings of ECpella, this extremely ill patient would not have survived this COVID-19 infection.”

This is the second EUA the FDA has granted for Impella during the COVID-19 pandemic. On May 29, 2020, the FDA issued an EUA to expand the use of Impella RP to include patients suffering from COVID-19-related right ventricular complications, including right ventricular dysfunction associated with pulmonary embolism. Combined, the two EUAs authorize the Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella RP for use in COVID-19 patients. Impella is the only cardiovascular therapeutic device that has received FDA emergency use authorization to treat COVID-19 patients.

Published academic research presented to the FDA that demonstrates the feasibility of ECpella to improve left ventricular function and provide oxygenation to patients includes:

Pappalardo et al., European Journal of Heart Failure, 2017: This study compared ECpella patients with patients treated with ECMO only and found patients in the ECpella group had a significantly lower hospital mortality (47% vs. 80%, p< 0.001) and a higher rate of successful bridging to either recovery or further therapy (68% vs. 28%, p < 0.001) compared with ECMO patients.
Schrage et al., Journal of the American College of Cardiology, 2018: In this study, 106 consecutive patients were treated with Impella in addition to VA-ECMO for cardiogenic shock and 51.9% of all patients were successfully weaned from VA-ECMO support. In the overall cohort, survival at day 30 was 35.8%, which was higher than predicted by the SAVE score (20%) or by the SAPS-II score (6.9%).
Patel et al., ASAIO Journal, 2019: This retrospective study compared mortality outcomes and duration of support, stroke, major bleeding, hemolysis, inotropic score, and cardiac recovery for patients treated for refractory cardiogenic shock with ECMO versus ECpella. ECpella patients were associated with lower mortality rates, lower inotrope use, and comparable safety profiles as compared with ECMO alone.

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