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 expa…