www.fdanews.com/articles/88327-fda-approves-abiomed-s-new-integrated-off-pump-cannula
FDA APPROVES ABIOMED'S NEW INTEGRATED OFF-PUMP CANNULA
July 12, 2006
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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