The CardioFit system works by applying electrical impulses to the vagus nerve. A sensing electrode in the right ventricle detects the patient’s heart rate and is used to control nerve stimulation.
The clinical trial study is taking place at sites in Europe, Israel, and Australia. In addition to Bergamo and Mannheim, Policlinico S.Matteo University Hospital in Pavia, Italy; Otto-von-Guericke University Hospital in Magdeburg, Germany; University Hospital Maastricht, in Maastricht, Netherlands, and Clinical Center of Serbia in Belgrade, Serbia are also enrolling patients for the CardioFit system study, and all of them have already successfully implanted the device in trial patients. A total of thirty patients will be enrolled in the study.
BioControl develops and markets 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.
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