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News Breaks
September 5, 2010
16:05 EDTHTWR
theflyonthewall.com: FDA gives HeartWare IDE allowing 2nd allotment of patients in pivotal trial
HeartWare International announced that the U.S. Food and Drug Administration-FDA-has approved an IDE (Investigational Device Exemption) Supplement that allows HeartWare to enroll a second allotment of 54 patients in its "ADVANCE" bridge-to-transplant clinical trial under a Continued Access Protocol (CAP). The FDA granted an initial allotment of 54 patients in April 2010 and the final patient was implanted under the initial allotment in August 2010. :theflyonthewall.com



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February 3, 2012
10:31 EDTHTWR
theflyonthewall.com: On The Fly: Analyst Initiation Summary

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06:44 EDTHTWR
theflyonthewall.com: HeartWare initiated with a Sell at ThinkEquity

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