BioControl nets CE Mark for heart failure device
BioControl Medical, a medical device company, reported that its CardioFit system has received a CE Mark certification, in accordance with the European active implantable medical device directive.
The Yehud, Israel-based company said its CardioFit is intended as a treatment for N.Y. Heart Association class II-III heart failure patients, who do not achieve symptomatic improvement through standard evidence based management. The system was approved for marketing in Europe based on the results of a recently completed pilot study.
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, according to BioControl.
The Yehud, Israel-based company said its CardioFit is intended as a treatment for N.Y. Heart Association class II-III heart failure patients, who do not achieve symptomatic improvement through standard evidence based management. The system was approved for marketing in Europe based on the results of a recently completed pilot study.
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, according to BioControl.