SAN RAMON, Calif., May 31, 2016 – BioVentrix Inc., an emerging medical device company for less invasive treatment of heart failure (HF), today announced that it has received a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial, named ALIVE (American Less Invasive Ventricular Enhancement).
The trial is designed to demonstrate the safety and effectiveness of the Revivent TC™ TransCatheter Ventricular Enhancement System; a hybrid closed-chest transcatheter procedure to treat patients suffering from ischemic cardiomyopathy by reshaping and restoring the left ventricle (LV). This is accomplished by implanting micro-anchoring pairs in the LV to exclude scarred myocardium from the healthy tissue.
The ALIVE trial plans to enroll 120 patients at up to 20 sites nationwide with a primary endpoint analysis at 1 year. The trial endpoints include positive effects on volume reduction, ejection fraction, quality of life (QOL), New York Heart Association (NYHA) Class, 6 minute walk test, and rehospitalization. Admission rates following heart failure hospitalization remain high, with ≥ 50% patients readmitted to hospital within 6 months of discharge. Annually, over 1 million patients are hospitalized with a primary diagnosis of heart failure, accounting for a total Medicare expenditure exceeding $17 billion.
BioVentrix has shown in multiple clinical trials in Europe that the exclusion of scar tissue from the LV cavity in patients suffering from ischemic cardiomyopathy and heart failure symptoms results in substantial improvements in LV volume, NYHA Class, 6 minute walk tests, and Quality of Life. Additionally, previous studies reported in the surgical literature have shown that a significant LV volume reduction conveys a survival benefit for treated patients.
Read more: Press Release, Press Release, BioVentrix receives FDA IDE Approval for its Pivotal Clinical Trial