Israel and Minnesota-based BioControl Medical said it secured clinical trial approval from Israel’s Ministry of Health for the Inovate-HF trial of its its CardioFit vagal nerve stimulation system for heart failure.

CardioFit is an implantable device designed to use electrical pulses to stimulate the vagus nerve and help regulate the heart beat.

The nod from Israeli regulatory authorities opens the Inovate-HF trial, run in the U.S. under an investigational device exemption from the FDA, to patients in Israel.

The study is comparing treatment with the CardioFit device and a drug regimen with treatment by prescription alone. BioControl plans to use the data to back a bid for pre-market approval from the American watchdog agency, which gave the IDE study the green light in early 2013.

“This will be the first time we recruit patients in our own country for a clinical trial with the CardioFit. We have anticipated the day when we could bring our technology to patients in Israel, and it is only fitting that we are able to include our neighbors, family and friends in our ground-breaking Inovate-HF trial,” president & CEO Ehud Cohen said in prepared remarks.