WorldHeart Receives Unconditional BTT Study Approval From FDA for Levacor(TM) VAD

Press Release Source: World Heart Corporation On Friday January 8, 2010, 9:00 am EST

SALT LAKE CITY, Jan. 8 /PRNewswire-FirstCall/ -- World Heart Corporation ("WorldHeart"; Nasdaq: WHRT), a developer of mechanical circulatory systems, announced today that it has received unconditional approval from the U.S. Food and Drug Administration ("FDA") for the bridge-to-transplant ("BTT") study of the Levacor Ventricular Assist Device ("VAD"). Study enrollment will encompass 160 subjects, a reduction from the approximately 200 subjects of the original statistical plan. As previously announced, the BTT study will begin initially at ten clinical sites.

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Global Administrator | 1/8/2010 11:05:14 AM | 0 Comments