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BioControl Medical gets Israeli approval to initiate clinical study of CardioFit system

Israel-based BioControl Medical has obtained the Israel Ministry of Health approval to conduct a clinical study of its CardioFit system in patients with chronic heart failure (HF) as part of the third-phase of INOVATE-HF (INcrease Of VAgal TonE in Heart Failure) study.

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Recently, the company has obtained the US Food and Drug Administration (FDA) approval to begin the third phase of INOVATE-HF.

The INOVATE-HF study of CardioFit is being conducted in 80 centers across the globe. The randomized, controlled clinical study was initiated in April 2011. It has been designed to the safety and efficacy of the CardioFit.

The INOVATE-HF will assess the CardioFit’s potential to decrease hospitalization and death among patients with HF, while also exploring whether combined treatment with the system and prescription drug therapy is more effective than drug therapy alone.

BioControl Medical CEO Dr Ehud Cohen noted this will be the first time we recruit patients in the company’s 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," Dr Cohen added.

In Israel, three medical centers will participate in the study including Barzilai in Ashqelon, Bnai-Zion (Rothschild) in Haifa, and Kaplan in Rehovot.

Patients diagnosed with Class III heart failure caused by left ventricular dysfunction who routinely take prescription drug therapy may qualify to participate in the trial. Patient enrollment is already underway.

CardioFit was developed to activate the parasympathetic nervous system directly to reduce stress on the heart, thereby alleviating HF symptoms and reversing HF deterioration. It operates by stimulating the vagus nerve on the right side of the neck.

CardioFit is designed to improve heart function and is the first medical device to treat chronic heart failure using neurostimulation.

The system features a stimulator, a sensor lead and a stimulation lead, which are implanted under the skin of the chest.

Once activated, electrical pulses of stimulator are transferred through the stimulation lead to the vagus nerve. Simultaneously, the sensor lead monitors changes in heart activity and turns stimulation on or off accordingly.

Like a pacemaker, the CardioFit system can be programmed on and off through external communication with the device.

The safety and performance of the CardioFit have been validated in a pilot clinical study conducted in Germany, Italy, The Netherlands and Serbia.

Results of this pilot study supported BioControl Medical’s filing for CE mark approval to market and sell CardioFit in the EU. The device obtained CE Mark approval in December 2008.


Image: BioControl Medical’s CardioFit system for chronic heart failure treatment. Photo: Courtesy of BioControl Medical