YEHUD, Israel--(BUSINESS WIRE)--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 is intended as a treatment for NYHA class II-III heart failure patients who have failed to achieve symptomatic improvement through standard evidence based management. The 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 system was approved for marketing in Europe based on the results of a recently completed pilot study.
“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,” said Dr. Ehud Cohen, CEO of BioControl Medical.
About BioControl Medical
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. The devices enable controlled electrical stimulation of various nerves to achieve therapeutic results. For more information please contact: email@example.com. To schedule an interview with Dr. Ehud Cohen, please contact Marjie Hadad, media liaison, at +972-54-536-5220 or at firstname.lastname@example.org.
Marjie Hadad, +972-54-536-5220 (media liaison)
Source: BioControl Medical