FDAnews Device Daily Bulletin

FDA APPROVES ABIOMED'S NEW INTEGRATED OFF-PUMP CANNULA

July 13, 2006
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Abiomed, Inc. today announced U.S. Foodand Drug Administration (FDA) approval of its Premarket ApprovalApplication (PMA) supplement for the Company's new integrated cannulasystem. The new cannula (previously referred to as "minimally invasivecannula") has the potential for use off-pump with minimally invasiveprocedures and is designed to integrate with Abiomed's AB5000(TM) andBVS(R) 5000 Circulatory Support Systems. The new cannula system iseasier to implant and explant and is expected to standardize surgicalprocedures for acute heart failure patients.
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