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.” To top
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