BioControl Medical Obtained an IDE approval for the INOVATE-HF study, an International Clinical Trial of the CardioFit(TM) System for Heart Failure in the U.S. and Europe
11/4/2010 11:38:33 AM
YEHUD, Israel & NEW-HOPE, Minn.--(BUSINESS WIRE)--BioControl Medical (http://www.biocontrol-medical.com/), developer of advanced implantable devices for the treatment of autonomic disorders, today announced U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and pivotal clinical trial protocol to begin evaluating the CardioFit™ system for the treatment of Congestive Heart Failure. As a result, the company will begin enrollment in the INOVATE-HF (INcrease Of VAgal TonE in chronic Heart Failure) clinical trial.
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