BioVentrix's Pivotal ALIVE Trial Receives IDE Approval From FDA

May 31, 2016—BioVentrix Inc. announced that it has received approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) to initiate the pivotal ALIVE (American Less Invasive Ventricular Enhancement) clinical trial.

The trial is designed to demonstrate the safety and effectiveness of the company’s Revivent TC transcatheter ventricular enhancement system in a hybrid closed-chest transcatheter procedure to treat patients with ischemic cardiomyopathy. The procedure reshapes and restores the left ventricle (LV) by implanting microanchoring pairs in the LV to exclude scarred myocardium from the healthy tissue.

According to the company, 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. Andrew Wechsler, MD, serves as the ALIVE trial’s lead United States Principal Investigator.

In the BioVentrix press release, Dr. Wechsler commented, “Heart failure continues to be an epidemic and the BioVentrix technology fills a critical need here in the United States 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. This IDE approval provides another treatment option that physicians can consider when exploring the best therapy solution for heart failure patients.”

BioVentrix noted that it has shown in multiple European clinical trials that the exclusion of scar tissue from the LV cavity in patients with ischemic cardiomyopathy and heart failure symptoms results in substantial improvements in LV volume, NYHA class, 6-minute walk tests, and QoL. Additionally, previous studies reported in the surgical literature have shown that a significant LV volume reduction conveys a survival benefit for treated patients.