Impella 5.5 heart pump receives US FDA nod

December 6, 2019 0 By FM

Abiomed’s Impella 5.5 with SmartAssist has received US FDA pre-market approval (PMA) for safety and efficacy in the therapy of cardiogenic shock for up to 14 days.

Impella 5.5, with SmartAssist, is minimally invasive and implanted via the axillary artery or the anterior aorta. 

Equipped with SmartAssist, it is designed to provide weaning algorithms to optimize survival and native heart recovery.

This temporary ventricular support device is intended for short term (14 days) use and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open-heart surgery or in the setting of cardiomyopathy.

It delivers peak flows of greater than 6 litres per minute. A motor housing that is thinner and 45% shorter than the Impella 5.0 improves the ease of pump insertion through the vasculature.

The approvals were based on analyses of Impella clinical results in 508 patients, which includes the FDA study RECOVER I, and the US Impella registry, and of Impella literature reviews of 801 patients in 33 clinical studies.