BioControl Medical has received approval from the Israel Ministry of Health to initiate a clinical study of its CardioFit system in patients with chronic heart failure (HF) as part of INOVATE-HF (‘INcrease Of VAgal TonE in Heart Failure’) study.
With this approval, Israel will join European countries and the US to participate in the company’s third phase of INOVATE-HF.
INOVATE-HF is a US Food and Drug Administration approved investigational device exemption study of CardioFit being conducted in 80 centres worldwide.
In Israel, three medical centres will participate in the study. These include 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 enrolment is already underway.
BioControl Medical initiated the randomised, controlled clinical study in April 2011 to assess the safety and efficacy of the CardioFit, an implantable electrical stimulation device designed to improve heart function and treat chronic heart failure using neurostimulation.
INOVATE-HF study will assess the CardioFit system’s potential to reduce hospitalisation and death among patients with HF.
In addition, the study will also explore whether combined treatment with CardioFit and prescription drug therapy is more effective than drug therapy alone.
BioControl Medical CEO Ehud Cohen said this will be the first time the company recruits patients in its 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 neighbuors, family and friends in our ground-breaking INOVATE-HF trial," Dr Cohen said.
CardioFit system has been developed to activate the parasympathetic nervous system directly to reduce stress on the heart, alleviating HF symptoms and reversing HF deterioration. The system operates by stimulating the vagus nerve on the right side of the neck.
CardioFit system has a stimulator, a sensor lead and a stimulation lead, which are implanted under the skin of the chest. Once activated, electrical pulses of the stimulator are transferred through the stimulation lead to the vagus nerve.
At the same time, the sensor lead monitors changes in heart activity and turns stimulation on or off accordingly. The CardioFit system, similar to a pacemaker, can be programmed on and off via external communication with the device.
CardioFit’s safety and performance have been validated in a 32-patient, pilot clinical study conducted in Germany, Italy, the Netherlands and Serbia.
The study data showed that patients experienced sustained significant improvement across key clinical measures, including left ventricular function and structure, heart rate variability and resting rate.
In addition, the pilot study demonstrated improvement in self-reported quality of life surveys and six-minute hall walk tests.
Based on these results, the company has received CE Mark approval in the EU in December 2008.
Image: BioControl Medical’s CardioFit system for chronic heart failure treatment. Photo: courtesy of BioControl Medical.