BioVentrix Revivent TC System Gains Expanded Access Program Approval From FDA

January 24, 2023—BioVentrix, Inc., announced that the FDA has approved its application for an Expanded Access Program (EAP) for the company’s Revivent TC transcatheter ventricular enhancement system.

BioVentrix stated that the Revivent TC system is designed to support a minimally invasive procedure to treat a dilated left ventricle in patients with ischemic heart failure with reduced ejection fraction and extensive left ventricular scar tissue who have a suboptimal response to guideline-directed medical therapy. The procedure, referred to as less invasive ventricular enhancement (LIVE) therapy, uses myocardial microanchor implants to reconstruct the dilated left ventricle to produce a more efficient chamber, noted the company.

According to BioVentrix, the EAP approval comes after the completion of enrollment in the ALIVE trial, a prospective, multicenter, dual-arm pivotal study of the Revivent TC system. Enrollment in the ALIVE trial was completed in April 2022.

Gregg W. Stone, MD, a Coprincipal Investigator of the ALIVE trial, commented in the company’s press release, “While awaiting data analysis and United States regulatory submission from the pivotal approval ALIVE trial, enrollment in the EAP 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.”

ALIVE Coprincipal Investigator Jerry D. Estep, MD, added, “Expanded access that permits ongoing usage of this investigational device is critically important. Patients with heart failure with high-risk features including significant shortness of breath despite medical management remain at high risk for disease progression and life-threatening events.”

Dr. Stone is 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 in New York, New York. Dr. Estep is Chair of Cardiology at Cleveland Clinic Florida in Weston, Florida.

BioVentrix markets the Revivent TC system in Europe. In the United States, the device is limited to investigational use only. The company is preparing to submit a premarket approval application to the FDA for Revivent TC in 2023.