Study Published in European Journal of Heart Failure Shows Significant and Sustained Improvement in Heart Function, Symptom Relief and Quality of Life Using Less Invasive Left Ventricular Enhancement Device

San Ramon, CA, Nov. 19, 2019 -- BioVentrix, Inc., a privately-held company with a first-in-class, transcatheter-based structural heart device to treat heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation status for its Revivent TC™ Transcatheter Ventricular Enhancement System for heart failure.

San Ramon, CA, USA – Oct. 07, 2019 – BioVentrix, Inc. announced the first patient was enrolled and treated in the REVIVE-HF European study, a prospective multi-center, dual-arm randomized controlled study evaluating the treatment of ischemic cardiomyopathy induced heart failure with the Revivent TC^™ System compared to Guideline-Directed Medical Therapy (GDMT) or drug treatment. 

To demonstrate that treatment with the Revivent TC^TM System is more effective than Guideline Directed Medical Therapy (GDMT) for the treatment of ischemic heart failure.