SAN RAMON, Calif.–(BUSINESS WIRE)–BioVentrix, Inc., developer of the first transcatheter device for left ventricular remodeling after a heart attack, today announced that Ralph Stephan von Bardeleben, MD, of the University Medical Center of Mainz (Germany) has joined the European REVIVE-HF clinical trial of the Revivent TC™ Transcatheter Ventricular Enhancement System as co-principal investigator.
Dr. von Bardeleben heads the Heart Valve Center and Center of Cardiology at the University of Mainz. He is an internationally recognized authority in interventional cardiology leading a specialized center for advanced transcatheter treatment concepts. He joins co-principal investigators Stefan Anker, MD, of the Berlin-Brandenburger Center for Regenerative Therapy (BCRT) and Volkmar Falk, MD, Medical Director and Director of the Department of Cardiothoracic Vascular Surgery at the German Heart Center, Berlin.
“I am enthusiastic about joining the investigation of this new approach providing a much-needed alternative to current guideline-directed medical therapy for ischemic heart failure,” Dr. von Bardeleben said. “As with catheter-based mitral valve interventions, which created an effective option for thousands of patients who could not undergo surgery, the Revivent TC System offers the hope of effective restoration of left ventricular function to many more patients without open surgery.”
REVIVE-HF is a prospective, multi-center, dual arm randomized controlled study being conducted in Europe comparing the treatment of ischemic cardiomyopathy-induced heart failure with the Revivent TC System to Guideline-Directed Medical Therapy (GDMT). The study encompasses 180 patients in a 2:1 study, comparing 120 patients treated with the investigational therapy with 60 patients in a control group treated with standard medical treatment alone. Endpoints include improvement in exercise capacity and quality of life as clinical functional parameters.
“Dr. von Bardeleben is a leader in less invasive catheter-based heart valve therapy,” Dr. Anker said. “We are pleased to add Dr. von Bardeleben as co-principal investigator of the REVIVE-HF clinical trial and feel his expertise in less invasive cardiac interventions will provide great value to the study.”
The first patient was enrolled and treated in the REVIVE-HF study in September 2019.
The company also recently announced that Gregg Stone, MD, director of academic affairs for the Mount Sinai Heart Health System and co-director at the Cardiovascular Research Foundation in New York City, NY, joined the U.S. pivotal trial of the Revivent TC system – the ALIVE Trial – as a co-principal investigator. Dr. Stone is considered a global expert on transcatheter cardiovascular devices and has served as a principal investigator for more than 100 randomized trials.
Less Invasive Ventricular Enhancement, or the LIVE™ Therapy, uses the Revivent TC System to exclude scar tissue on the left ventricle that has occurred from a heart attack so the healthy portion of the heart can operate more efficiently. Micro-anchors are implanted and designed to remodel the heart to a more normal shape and size and reduce wall stress, which has been shown to improve blood flow throughout the body.
BioVentrix is a privately held medical device company headquartered in San Ramon, CA, USA. Its mission is to improve and expand the treatments available for congestive heart failure (CHF) caused by ischemic cardiomyopathy through the development of less invasive, catheter-based approaches.
Note: The Revivent TC™ System has received the CE Mark and is approved for sale in Europe. It is considered investigational and is not approved for sale in the United States.