FDA Approves Mini Blood Pump System

The Food and Drug Administration (FDA) has approved Abiomed’s Impella 2.5 System, a mini blood pump system intended for temporary use by patients with severe symptomatic coronary artery disease (CAD) and diminished but stable heart function who are undergoing high-risk percutaneous coronary intervention (HRPCI) procedures (eg, balloon angioplasty, stenting) but are not candidates for surgical coronary bypass treatment.

The Impella 2.5 System helps maintain stable heart function throughout the HRPCI procedure by drawing blood from the left ventricle and pumping it into the aorta. Once the system is in place in the left ventricle, an external controller and monitor turns the pump on and off and measures heart function. The healthcare provider can adjust the pump as needed to maintain stable heart function and circulation.

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The FDA’s approval was supported by clinical data from the PROTECT II study and data from the USpella Registry, a multi-center, observational registry. The study showed that for patients with severe CAD and diminished heart function, using Impella 2.5 System during a HRPCI procedure may allow for a longer and more through procedure by preventing episodes of hemodynamic instability due to temporary heart function abnormalities. Also, fewer later adverse events may occur in patients undergoing HRPCI with the pump compared to patients undergoing HRPCI with an intra-aortic balloon pump.

The Impella 2.5 System is approved as a class III medical device.

For more information visit Abiomed.com.