BioVentrix, a privately held medical device company focused on the development of less invasive therapies to directly treat the dilated left ventricle and reverse the left ventricular remodelling process of progressive heart failure, today announced the US Food and Drug Administration (FDA) has approved its application for an Expanded Access Program (EAP) for Revivent TC System.
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, utilises myocardial micro-anchor implants to reconstruct the dilated left ventricle to produce a more efficient chamber.
The approval for an Expanded Access Program follows the successful completion of enrolment in the ALIVE (American Less Invasive Ventricular Enhancement) trial, a prospective, multi-centre, dual-arm pivotal study of the BioVentrix Revivent TC System. Enrolment 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 remodelling in ischemic and non-ischemic heart failure,” said Jim Dillon, president and CEO of BioVentrix. “Heart failure patients with reduced ejection fraction that are not responsive to standard-of-care therapies may now have access to LIVE therapy, currently under investigation.”
“While awaiting data analysis and US regulatory submission from the pivotal approval ALIVE trial, enrolment 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,” said Gregg Stone (Icahn School of Medicine at Mount Sinai, New York, USA), co-principal investigator of the ALIVE trial.
“Expanded access that permits ongoing usage of this investigational device is critically important,” said Jerry Estep (Cleveland Clinic Florida, Florida, USA), co-principal investigator for the ALIVE trial. “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.”