June 1, 2016 — BioVentrix Inc. 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.
"Heart failure continues to be an epidemic and the BioVentrix technology fills a critical need here in the U.S. for ischemic patients," said lead U.S. principal investigator Andrew Wechsler M.D. "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. This IDE approval provides another treatment option that physicians can consider when exploring the best therapy solution for heart failure patients."
The ALIVE trial plans to enroll 120 patients at up to 20 sites nationwide with a primary endpoint analysis at one year. 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. Admission rates following heart failure hospitalization remain high, with ≥ 50 percent of 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 all trial endpoints. Additionally, previous studies reported in the surgical literature have shown that a significant LV volume reduction conveys a survival benefit for treated patients.
Placement of the Revivent TC System via the LIVE procedure obviates the need for more invasive surgery. Instead, small titanium anchors are placed along the outer surface of the heart and along one of the interior walls via a closed-chest, endovascular approach. The anchors are then pulled toward one another, effectively excluding the scarred and non-functioning heart wall. Ventricular volume is immediately reduced as a result of the exclusion, by as much as 30-40 percent.
For more information: www.bioventrix.com