First implants for BioControl’s device for congestive heart failure

13 August 2007

Yehud, Israel. Cardiologists and surgeons at University Hospital Mannheim in Germany and at Ospedali Riuniti di Bergamo in Italy have successfully implanted BioControl's CardioFit device in the first patients. The patients are part of BioControl’s international, multi-center, open-label clinical study of the CardioFit system for the treatment of advanced congestive heart failure.

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.

The study is now in progress at IRB-approved sites in Europe, Israel and Australia. Bergamo and Mannheim join four other sites in Europe actively enrolling patients for the CardioFit system study, all of which have already successfully implanted the device in trial patients.

These include: Policlinico S.Matteo University Hospital in Pavia, Italy; Otto-von-Guericke University Hospital in Magdeburg, Germany; University Hospital Maastricht, in Maastricht, Netherlands, and Clinical Center of Serbia in Belgrade, Serbia. A total of thirty patients will be enrolled in the study.

“I can confirm that the first patient we have enrolled at Mannheim in the BioControl study has been successfully implanted with the CardioFit device. The patient is 60+ years of age and suffers from ischemic heart failure with a very low ejection fraction and a high basal heart rate despite treatment with maximally tolerated doses of beta blockers. The patient is in satisfactory condition after the procedure and has not exhibited any adverse side effects. Our early results support our belief that CardioFit may contribute significantly to how heart failure patients are treated in the future,” said Professor M. Borggrefe, Principal Investigator of the BioControl trial at Mannheim.

Professor A. Gavazzi, Principal Investigator of the BioControl study at Bergamo said: “I am pleased to report that we have implanted the first person in the BioControl study at Bergamo with the CardioFit device. The patient is 31 years old and suffers from familial dilated cardiomyopathy. The patient is resting comfortably and is in very good spirits after the procedure. This patient, like the others in this study, had been treated with optimal doses of conventional heart failure therapies, including high doses of beta blockers, was still symptomatic. Clearly, there is an unmet clinical need for effective treatments for this condition. We believe the CardioFit system has a high potential to fill this need.”

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