BioVentrix has obtained investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to start its clinical trial to evaluate the safety and effectiveness of the Revivent TC transCatheter ventricular enhancement system.
Under the American Less Invasive Ventricular Enhancement (ALIVE) trial, the Revivent TC system will be assessed to treat patients suffering from ischemic cardiomyopathy by reshaping and restoring the left ventricle (LV).
The company intends to enroll around 120 patients at 20 sites across the US.
The trial endpoints include positive effects on volume reduction, ejection fraction, quality of life (QOL), New York Heart Association (NYHA) Class, six minute walk test, and rehospitalization.
ALIVE trial US principal investigator Andrew Wechsler said: "Heart failure continues to be an epidemic and the BioVentrix technology fills a critical need here in the U.S. for ischemic patients.
"The current therapy, surgical ventricular reconstruction, is effective yet it is highly invasive and limited in terms of patients being able to withstand the procedure."
BioVentrix Medical Affairs vice president Ryan Brown said: "The Revivent TC system has recently demonstrated efficacy in clinical trials performed in the EU."
The company has demonstrated in several clinical trials in Europe that the exclusion of scar tissue from the LV cavity in patients suffering from ischemic cardiomyopathy and heart failure symptoms leads to substantial improvements in LV volume, NYHA Class, 6 minute walk tests, and Quality of Life.
Earlier studies reported in the surgical literature have shown that a significant LV volume reduction conveys a survival benefit for treated patients.