Medical device developer BioControl Medical announced today 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.
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.
BioControl Medical CEO Dr. Ehud Cohen 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."
Yehud-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.
In November, following the following the successful completion of its pilot trial on humans, BioControl laid off nine of its 33 employees, as they had been working on that trial. At that time, Cohen said that the company planned a larger trial in the US, and would hire staff there to manage it.
Published by Globes [online], Israel business news - www.globes-online.com - on January 7, 2009
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