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 higher-risk procedures such as angioplasty, when a blocked artery is unclogged using an inflated balloon, the agency said.
The system is guided into the left ventricle of the heart via a catheter that's typically inserted into a leg artery. 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.
People with coronary artery disease commonly have diminished blood flow to the heart, which could lead to serious complications during surgery, the agency said.
The Impella System is produced by Abiomed Inc., based in Danvers, Mass.
The FDA has more about this approval.