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news.BioControl Medical, a privately-held medical device company, has announced that its CardioFit system has received a CE Mark certification from KEMA, a Dutch notified body, in accordance with the European active implantable medical device directive.
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CardioFit is intended as a treatment for New York Heart Association class II-III heart failure patients who have failed to 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.
Ehud Cohen, CEO of BioControl Medical, said: “This is very exciting news for BioControl Medical as it provides an important seal of quality for CardioFit and opens important markets. We are grateful to the physicians who worked with us in the clinical study and provided us with the opportunity to introduce this therapeutic technology to clinical practice.”