Published on July 28, 2010 at 12:57 AM
World Heart Corporation (WorldHeart) (Nasdaq:WHRT), a developer of mechanical circulatory systems, announced today that the United States Food and Drug Administration (FDA) has approved the addition of ten sites to the Levacor ventricular assist device (VAD) Bridge-to-Transplant (BTT) clinical study. WorldHeart's pivotal BTT study is now approved to enroll patients at 20 sites in the U.S.
"Leading cardiovascular centers and clinicians have expressed strong interest in the Levacor BTT study since its initiation earlier this year," noted Mr. J. Alex Martin, WorldHeart's President and Chief Executive Officer. "We welcome the opportunity to increase enrollment through new study sites, which will expand the data regarding the Levacor VAD's technical and clinical performance capabilities. The BTT trial activity to date, including out-of-hospital experience, has been encouraging and this FDA approval permits further advancement of the study."
Source World Heart Corporation