by
Joan Trombetti, Writer | January 09, 2009
BioControl Medical's cardio device has received CE Mark certification. Their CardioFit system works by applying electrical impulses to the vagus nerve. In a statement released by BioControl Medical, the CardioFit system has received a CE Mark certification from KEMA, a Dutch notified body, in accordance with the European Active Implantable Medical Device Directive.
CardioFit works by applying electrical impulses to the vagus nerve. It is intended as a treatment for some heart failure patients, who have failed to achieve symptomatic improvement through standard management.
A sensing electrode in the right ventricle detects the patient's heart rate and is used to control nerve stimulation. The system was approved for marketing in Europe based on the results of a recently completed pilot study.
Yehud, Israel-based BioControl develops and markets 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.
