Abiomed's cardiopulmonary support system Ok'd in the U.S.

Oct. 26, 2020 10:25 AM ETAbiomed, Inc. (ABMD)By: Vandana Singh, SA News Editor
  • The FDA has granted Abiomed (NASDAQ:ABMD +1.9%) a 510(k) clearance for an all-in-one, compact cardiopulmonary bypass system, Abiomed Breethe OXY-1 System.
  • The system provides cardiopulmonary bypass support for patients whose lungs can no longer provide sufficient end organ oxygenation. The 510(k) clearance is to pump, oxygenate, and remove carbon dioxide from blood during cardiopulmonary bypass for up to six hours.
  • The system can help provide oxygenation to patients suffering from cardiogenic shock or respiratory failure, and when used with the Impella heart pump it can unload the heart and oxygenate the body.
  • Abiomed plans to have a controlled launch of the Breethe system at hospitals in the U.S., with full U.S. commercial availability expected in next year.

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