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Smallest Heart Pump From Abiomed Gets FDA Breakthrough Device Tag

The FDA has granted breakthrough device designation to Abiomed Inc’s (NASDAQ:ABMD) Impella ECP expandable percutaneous heart pump. Abiomed designed the Impella ECP…
byVandana Singh
August 18, 2021
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  • The FDA has granted breakthrough device designation to Abiomed Inc’s (NASDAQ:ABMD) Impella ECP expandable percutaneous heart pump.
  • Abiomed designed the Impella ECP heart pump to be compatible with small-bore access and closure techniques. It measures 3 mm in diameter when inserted and removed from the body. 
  • It expands in the heart to support its pumping function and provides a flow greater than 3.5 L/min.
  • Abiomed’s breakthrough device designation follows the FDA’s premarket approval of its Impella RP right heart pump in June.
  • Related content: Benzinga’s Full FDA Calendar.
  • Price Action: ABMD shares are up 1.34% at $332.97 during the market session on the last check Wednesday.
 
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