DANVERS, MA — The US Food and Drug Administration has given premarket approval to use the Impella 2.5, Impella CP, Impella 5.0, and Impella LD (Abiomed) heart pumps on patients suffering from cardiogenic shock less than 48 hours after acute MI or open-heart surgery, the device maker announced.
The percutaneous left side heart pumps are designed to stabilize patient hemodynamics, unload the left ventricle, perfuse end organs, and allow for heart recovery in this setting.
The devices are intended for short-term use: less than 4 days for the Impella 2.5 and CP models and less than 6 days for the Impella 5.0 and LD models.
Product labeling will also allow for the device to be left in place beyond the 4 to 6 days if a clinical decision is made due to unforeseen circumstances.
These are now the first percutaneous temporary ventricular support devices FDA-approved as safe and effective for the cardiogenic shock indication, according to Abiomed.
To support the approval, the company submitted data from the 415-patient RECOVER 1 study and the US Impella registry, a review of data from 692 patients treated with Impella in 17 clinical studies, and a safety analysis of more than 24,000 patients using the FDA's medical device reporting database.
In addition, Abiomed also provided a benchmark analysis of Impella patients in the real-world Impella cVAD registry vs these same patient groups in the Abiomed AB5000/BVS 5000 registry.
The company claims this is the most comprehensive review ever submitted to the FDA for circulatory support in the cardiogenic-shock population.
The approval was not expected until late summer 2016. Abiomed reports it currently treats only around 5% of the AMI cardiogenic-shock patient population.
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Cite this: FDA Approves Abiomed's Impella Heart Pumps for Cardiogenic Shock - Medscape - Apr 08, 2016.