BioControl Medical, the Israel based company in developing advanced implantable devices for the treatment of autonomic disorders, has commenced an international, multi-centre, open-label clinical study of its CardioFit system for the treatment of congestive heart failure.

CardioFit, a new electrical stimulator system designed to improve heart function through the controlled stimulation of the vagus nerve, will be studied at seven Institutional Review Boards (IRB) approved sites in Europe, Israel and Australia. According to the company announcement, the early data compiled by the company shows that the CardioFit system is safe to implant in patients with NYHA class III heart failure.

The pre-clinical and preliminary clinical data demonstrate that vagus nerve stimulation has a therapeutic role in treating heart failure as it may reduce the heart rate and ventricular volumes in addition to restoring regular rhythm and the product has found to be safer in this field.

The primary target of the study is to determine the occurrence of all adverse events resulting from the system and the implant procedure. The secondary endpoints include symptomatic, functional, and structural status as well as a review of biological serum markers. The study investigators will collectively enrol 20 to 30 patients, between the ages of 18 and 75 who meet the inclusion or exclusion criteria, for a period of one year, according to the company officials.

"The CardioFit system is a novel therapy designed for a clinically unmet need. Of the existing neurostimulation device therapies currently in clinical development for cardiology indications, the CardioFit system is clearly the most advanced and has the most significant probability for success," said BioControl CEO Dr Ehud Cohen.

According to some estimates, approximately 1.2 per cent to 2 per cent of the global population and as many as 10 per cent of individuals 65 years and older suffer from heart failure because of heart failure include hypertension, ischemic heart disease and valvular disease.

BioControl, in engaged in developing and marketing advanced implantable devices for the treatment of autonomic disorders, conditions whereby the autonomic nervous system ceases to function properly resulting in a disruption to the control of involuntary body processes.

The devices enable controlled electrical stimulation of various nerves to achieve therapeutic results. The American Medical Systems exclusively licensed BioControl's technology for its miniaturo system, in April 2006, to develop it as a treatment device for urge incontinence and interstitial cystitis.

The company informed that the funds secured from the transaction are being used to support the development of the CardioFit system for the treatment of congestive heart failure.