SAN RAMON, Calif. – January 6, 2021 – BioVentrix, Inc., a privately held medical device company focused on treating congestive heart failure (CHF) via Transcatheter Ventricular Restoration (TCVR), today announced that heart failure specialist Jerry Estep, MD, of the Cleveland Clinic has been appointed co-principal investigator of the pivotal ALIVE Trial studying LIVE Therapy using the Revivent TC™ TransCatheter Ventricular Enhancement System. He joins co-principal investigators Gregg Stone, MD, of New York’s Mount Sinai Health System and Andrew Wechsler, MD, of Philadelphia’s Drexel University College of Medicine in overseeing the trial.
Dr. Estep specializes in managing advanced heart failure patients and is the Head of the Section of Heart Failure and Transplantation in the Tomsich Family Department of Cardiovascular Medicine in the Sydell and Arnold Miller Family Heart, Vascular and Thoracic Institute at the prestigious Cleveland Clinic. He has participated in more than 75 clinical trials related to heart failure and has authored or co-authored more than 200 published articles and abstracts related to advanced heart failure, cardiac transplantation, LVADs and multi-modality imaging. He served as the lead investigator of the Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients (ROADMAP) Study. He also served as a co-chair of the American Society of Echocardiography guideline document that defined the role of echocardiography in the management of LVAD patients.
“LIVE Therapy aligns with the goals of Cleveland Clinic in treating symptomatic heart failure,” said Dr. Estep. “We focus on a tailored team approach for the treatment of heart failure patients that first entails recovering the native heart to minimize the progression to an end-stage disease. LIVE Therapy provides a potential solution that allows us to less invasively exclude scar tissue for ischemic heart failure patients. I am excited about the opportunity to help lead this important study with the potential to reshape the way we treat patients with left ventricular dysfunction.”
The ALIVE Trial is designed to demonstrate the safety and effectiveness of the Revivent TC System, a hybrid, minimally invasive transcatheter procedure designed to treat patients suffering from ischemic cardiomyopathy by reshaping and restoring the left ventricle (LV). In the procedure, micro-anchors are implanted in the LV to exclude scarred myocardium from the healthy tissue.
„Dr. Estep is an important addition to the ALIVE Trial as he will help us continue to define the role that LIVE Therapy can play in the continuum of care for heart failure patients,” said ALIVE Trial co-principal investigator Gregg Stone, MD. “Patients with heart failure have a very poor prognosis, with a mortality rate of 50 percent at five years. LIVE Therapy is designed as a less invasive option with the potential to improve the lives of patients with ischemic left ventricular dysfunction post-myocardial infarction.”
The ALIVE Trial plans to enroll 126 patients at up to 25 sites in the U.S., with a primary endpoint analysis at one year. The trial endpoints include positive effects on quality of life, New York Heart Association (NYHA) Functional Class, exercise capacity compared to baseline, and rehospitalization.
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 CHF caused by ischemic cardiomyopathy through the development of less invasive, catheter-based approaches. The FDA granted Breakthrough Device Designation Status for the Revivent TC System for heart failure in November 2019, which confirms the importance and the need for the therapy in the U.S. market.
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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.
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