SAN RAMON, Calif.--(BUSINESS WIRE)--BioVentrix, Inc., a pioneer of technologies and procedures for the less invasive treatment of heart failure (HF), today announced that Gregg Stone, MD, of New York’s Mount Sinai Health System has signed on to the pivotal ALIVE Trial of the Revivent TC™ TransCatheter Ventricular Enhancement System as co-principal investigator.
Dr. Stone is director of academic affairs for the Mount Sinai Heart Health System and the Co-Director of Medical Research and Education at the Cardiovascular Research Foundation in New York City, NY.
He has served as the national or international principal investigator for more than 100 national and international multicenter randomized trials, many of which have led to FDA clearance of new medical devices or indications in the U.S. Dr. Stone has authored more than 2,000 manuscripts and abstracts published in peer-reviewed literature, as well as numerous book chapters, and is a highly sought speaker at cardiology seminars around the world.
“The LIVE Therapy using the Revivent TC System is one of the most promising approaches I’ve seen for the lesser invasive treatment of left ventricular scarring from ischemic cardiomyopathy,” said Dr. Stone. “I’m excited about the potential for this therapy to improve prognosis and quality of life for suffering patients with advanced heart failure.”
The ALIVE Trial is designed to demonstrate the safety and effectiveness of the Revivent TC System, a hybrid, closed-chest 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.
"Heart failure continues to be an epidemic, and the BioVentrix technology fills a critical need here in the U.S. for ischemic patients," said ALIVE Co-Principal Investigator Andrew Wechsler, MD, emeritus professor of cardiothoracic surgery at Drexel University College of Medicine. "The current therapy, surgical ventricular reconstruction, is effective but highly invasive, which limits its utility. The addition of Dr. Stone to the ALIVE Trial as a co-principal investigator will significantly heighten awareness and acceptance of the trial in the cardiology community as we continue to advance to our enrollment goal.”
The ALIVE Trial plans to enroll 120 patients at up to 20 sites in the U.S. with a primary endpoint analysis at one year. The trial endpoints include positive effects on volume reduction, ejection fraction, quality of life, New York Heart Association (NYHA) failure class compared to baseline, exercise capacity, and rehospitalization.
View a testimonial from one patient who has experienced Less Invasive Ventricular Enhancement™ (LIVE™ Therapy) using the Revivent TC System.
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.