The U.S. Food and Drug Administration said it approved Abiomed's miniature blood pump system that maintains heart function and circulation during high-risk procedures.
The device, Impella 2.5 System, can be used during angioplasty and stenting, the regulator said.
Angioplasty and stenting are procedures used to re-open arteries in the heart that are blocked due to coronary artery disease, a condition that is the leading cause of death in the United States.
The FDA said data showed few later adverse events in patients using the pump during procedures, compared to those using the conventional intra-aortic balloon pump.
The Impella 2.5 System draws blood from the left lower chamber of the heart and pumps it to the main blood vessel to maintain stable heart function.
The device can be used in patients who have severe coronary artery disease but are not candidates for bypass treatment, the regulator said.
"We are excited that Impella has been recognized as a device that can potentially become the new standard of care," said Abiomed CEO Michael R. Minogue.
© 2023 Thomson/Reuters. All rights reserved.