BioVentrix, a medical device company focused on the development of less-invasive therapies to directly treat the dilated left ventricle and reverse the left ventricular remodeling process of progressive heart failure, announces the U.S. FDA has approved its application for an Expanded Access Program (EAP) for the Revivent TC System to treat ischemic heart failure.
The BioVentrix Revivent TC System is designed to support a minimally invasive procedure to treat a dilated left ventricle of patients with ischemic heart failure with reduced ejection fraction (HFrEF) and extensive left ventricular scar, who have a suboptimal response to guideline-directed medical therapy. The procedure, referred to as less invasive ventricular enhancement (LIVE) therapy, utilizes myocardial micro-anchor implants to reconstruct the dilated left ventricle to produce a more efficient chamber.
“While awaiting data analysis and US regulatory submission from the pivotal approval ALIVE Trial, enrollment in the Expanded Access Program will allow ongoing usage of the device and new insights into the predictors and magnitude of improvement of high-risk patients with heart failure undergoing the LIVE Procedure,” says Gregg W. Stone, MD, co-principal investigator of the ALIVE Trial; director of academic affairs for the Mount Sinai Heart Health System; and professor of Medicine and Population Health Sciences and Policy at the Icahn School of Medicine at Mount Sinai, New York.
The approval for an Expanded Access Program follows the completion of enrollment in the ALIVE (American Less Invasive Ventricular Enhancement) Trial, a prospective, multi-center, dual-arm pivotal study of the BioVentrix Revivent TC System. Enrollment in the ALIVE Trial was completed in April 2022.
“The Expanded Access Program is a significant step for BioVentrix as we continue to build our real-world evidence to treat a dilated left ventricle, a maladaptive consequence of cardiac remodeling in ischemic and non-ischemic heart failure,” says Jim Dillon, president and CEO of BioVentrix. “Heart failure patients with reduced ejection fraction (HFrEF) that are not responsive to standard-of-care therapies may now have access to LIVE Therapy, currently under investigation.”