FDA Agrees to Expanded Access Program for the BioVentrix Revivent TC System for the Treatment of Ischem
Treatment IDE Will Provide Opportunity to Treat Additional Patients in the US
SAN RAMON, Calif., Jan. 24, 2023 /PRNewswire/ -- BioVentrix, Inc., 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 remodeling 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.
FDA Agrees to Expanded Access Program for the BioVentrix Revivent TC System for the Treatment of Ischemic Heart Failure
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, utilizes myocardial micro-anchor implants to reconstruct the dilated left ventricle to produce a more efficient chamber.
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