Vagus Nerve Stimulator Treats Heart Failure

A new system for the treatment of congestive heart failure (CHF) functions by controlled stimulation of the vagus nerve.

The CardioFit system consists of an electro-stimulator device with a nerve cuff electrode and an intra-cardiac electrogram (EGM) sensor. By continuously monitoring the EGM signal, stimulation is adjusted to the patient's optimal heart rate. The vagus nerve is stimulated through a propriety tri-polar cuff electrode that provides accurate control over specific nerve fibers, thus avoiding cross activation of undesired fibers. The device is implanted during a short procedure in which the electrode is positioned around the vagus nerve in the neck and the device itself is placed in a subcutaneous pocket in the chest.

The CardioFit was developed by BioControl Medical (Yehud, Israel). The company has announced that a clinical study of the CardioFit system has been approved by institutional review boards (IRBs) in Europe, Israel, and Australia. The primary endpoint of the study is to determine the occurrence of all adverse events resulting from the system and/or the implant procedure. Secondary endpoints include symptomatic, functional, and structural status as well as a review of biologic serum markers.

"I have recruited several patients to the study thus far. It is my opinion that the CardioFit system has great potential as a useful treatment for heart failure,” said Professor Peter Schwartz, the study's principal investigator at Policlinico S.Matteo University Hospital (Pavia, Italy).

It is estimated that approximately 1.2–2% of the global population and as many as 10% of individuals 65 years and older suffer from CHF. Causes include hypertension, ischemic heart disease, and valvular disease.



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