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FDA Agrees to Expanded Access Program for the BioVentrix® Revivent TC® System for the Treatment of Ischemic Heart Failure
News provided byBioVentrix, Inc.
Jan 24, 2023, 7:36 AM ET
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.
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.
The approval for an Expanded Access Program follows the successful completion of enrollment in the ALIVE (American Less Invasive Ventricular Enhancement) Trial, a prospective, multi-center, dual-arm pivotal study of the BioVentrix Revivent TC System. Enrollment 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 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."
"While awaiting data analysis and US regulatory submission from the pivotal approval ALIVE 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 with heart failure undergoing the LIVE Procedure," said Gregg W. Stone, MD, Co-Principal Investigator of the ALIVE Trial, Director of Academic Affairs for the Mount Sinai Heart Health System and Professor of Medicine and Population Health Sciences and Policy at the Icahn School of Medicine at Mount Sinai, New York.
"Expanded access that permits ongoing usage of this investigational device is critically important," said Jerry D. Estep, MD., Co-Principal Investigator for the ALIVE Trial and Chair of Cardiology, Cleveland Clinic Florida. "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."
BioVentrix, Inc. is a privately held medical device company focused on the development of less invasive therapies to treat the failing left ventricle (LV), the most common cause of heart failure. BioVentrix technologies aim to improve cardiac function by directly addressing LV dilation. The Company markets the Revivent TC System in Europe and is preparing to submit the Premarket Approval (PMA) application to the FDA for the system later this year.
The BioVentrix, LIVE and Revivent TC trademarks are federally registered trademarks owned by BioVentrix. Any unauthorized use is expressly prohibited. Investigational Device.
Limited to Investigational Use Only In The United States.
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SOURCE BioVentrix, Inc.