BioVentrix announced today that it received FDA approval for its application for an expanded access program for the Revivent TC system.
San Ramon, California-based BioVentrix designed the Revivent TC system to support a minimally invasive heart procedure. It treats a dilated left ventricle of patients with ischemic heart failure. They also have reduced ejection fraction and extensive left ventricular scar. These patients have a suboptimal response to guideline-directed medical therapy.
The procedure — called less invasive ventricular enhancement (LIVE) therapy — uses myocardial micro-anchor implants. These implants help to reconstruct the dilated left ventricle, producing a more efficient chamber.
Approval follows the successful completion of enrollment in the ALIVE trial. The prospective, multi-center, dual-arm pivotal study evaluating the Revivent TC system completed enrollment in April 2022.
Gregg Stone, co-principal investigator, said the expansion allows the ongoing usage of the device. This could provide insights into the “predictors and magnitude of improvement” in patients undergoing the LIVE procedure.
“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,” said 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.”
