Abiomed’s Blood Pump Device Gets FDA Nod Again

The Impella 2.5 heart pump has received FDA Pre-Market Approval, making it the first PMA-indicated device for high-risk coronary intervention procedures, Abiomed announced Monday.

The device bears the distinction of being the world’s smallest heart pump and received 510(k) clearance in 2008 for several indications, including PCI procedures, but was reevaluated for a PMA through the FDA 515 initiative.

Designed as a temporary (six hours or less) ventricular support device for patients with severe coronary artery disease and depressed left ventricular ejection fraction, the Impella 2.5 is used to prevent possible hemodynamic instability during a planned temporary coronary occlusion, and can help mitigate peri- and post-procedural adverse events, according to the Danvers, Mass., devicemaker. Based on the product labeling, the device can stay in place longer than the six-hour mark, if necessary.

New clinical trials were not required by the FDA during the PMA review period. However, the regulatory body examined data on the Impella 2.5, including the U.S. Impella registry results, the PROTECT I and PROTECT II trials, as well as supporting evidence from more than 215 publications and an MDR analysis covering 13,981 patients.

The Impella 2.5 stayed on the market during the PMA reevaluation process. — Jason Scott