BioVentrix gets Expanded Access Approval for Left Ventricle Support System
The FDA has approved BioVentrix’s application for an Expanded Access Program (EAP) to permit ongoing usage of its investigational device — Revivent TC System — which treats the left ventricle in patients with progressive heart failure.
The system supports a minimally invasive procedure using myocardial micro-anchor implants to reconstruct the dilated left ventricle. The procedure treats patients with ischemic heart failure who have reduced ejection fraction and extensive left ventricular scarring and have a suboptimal response to guideline-directed medical therapy.
The approval for the EAP follows the April 2022 completion of enrollment in a prospective, multi-center, dual-arm pivotal study of the device.
While awaiting data analysis and regulatory submission from the pivotal approval 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,” the company said.