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FDA Approves New Miniature Blood Pump System

Maintains circulation during high-risk percutaneous coronary intervention procedures

TUESDAY, March 24, 2015 (HealthDay News) -- The Impella 2.5 System has been approved by the U.S. Food and Drug Administration to maintain stable heart function and blood circulation during high-risk cardiac operations, the agency said in a news release.

The miniature blood pump is sanctioned for coronary artery disease patients during high-risk percutaneous coronary intervention procedures, such as balloon angioplasty and stenting.

The system is guided into the left ventricle of the heart via a catheter that's inserted into one of the body's large arteries. An external controller and monitor turns the pump on and off, measures heart function, and allows doctors to adjust the pump as needed, the FDA said.

"Use of the Impella 2.5 System is intended to prevent episodes of unstable heart function, including unstable blood pressure and poor circulation, in patients who are at high risk for its occurrence," William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in a statement.

The Impella System is produced by Abiomed, based in Danvers, Mass.

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