FDA Expands Impella Heart Pumps Use Duration

Patrice Wendling

May 14, 2019

The US Food and Drug Administration (FDA)-approved labeling for the Impella 5.0 and Impella LD heart pumps (Abiomed) has been expanded to allow for longer support time in critically ill patients, the company announced today.

The devices are approved as therapy to allow for native heart recovery in myocardial infarction patients in cardiogenic shock, and for shock associated with peripartum cardiomyopathy or myocarditis. The expanded indication extends the duration of support for each pump from 6 to 14 days.

The Impella 5.0 is implanted through the femoral or axillary artery and the Impella LD is implanted directly into the aorta. The FDA's original approval of the Impella device for the treatment of cardiogenic shock was granted in 2016.

In February, the FDA warned in a letter to healthcare providers that interim results of a postapproval study of the Impella RP heart pump, approved in 2017 to provide temporary support of right ventricular function, suggested a higher than expected risk for death.

Survival to 30 days after device removal or hospital discharge, or to heart transplant or receipt of a surgically implanted right ventricular device, was 73.3% with the Impella RP system in premarket studies and 17.4% in the postapproval study.

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