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 The company's shares rose about 2 percent to $62.42 in after-market
trading on Monday.
The device, Impella 2.5 System, can be used during angioplasty and
stenting, the regulator said. (http://1.usa.gov/1xWUGfq)
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.
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(Reporting by Amrutha Penumudi and Anjali Rao Koppala in Bengaluru;
Editing by Sriraj Kalluvila)
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