NEWS
The Heart Center at Georg-August University of Göttingen in Germany Joins
BioControl Medical’s International Study of the CardioFit™ System for Heart Failure
Göttingen is the seventh European clinical center to implant the CardioFit device in a patient.
Yehud, Israel, October 17, 2007 --- BioControl Medical announced today that the Heart Center at Georg-August University of Göttingen, Germany is the seventh clinical site in Europe to implant the CardioFit system in a patient. The CardioFit system is currently being studied as a treatment for advanced congestive heart failure in an international, multi-center, open-label study at clinical sites in Europe, Israel and Australia.
The principal investigators of BioControl’s CardioFit study at the Heart Center at Georg-August University Göttingen include: Heart Failure Cardiologist Professor Gerd Hasenfuss, Electrophysiologist Professor Markus Zabel and Surgeon Dr. Dieter Zenker.
“The patient is a 65 year old man with single chamber ICD. His condition was an NYHA class IV and he had an EF of 16%, which is very poor. For the last six months he had been on a full regime of heart failure medication. Though his condition had been stable, he was not satisfied with his low level of activity,” said Professor Zabel.
The CardioFit system increases the parasympathetic tone 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 procedure lasted for about two hours. There were no complications. The patient recovered well and was released from the hospital two days after the implantation. The patient is now engaged in post-procedure therapy, which together with follow up, will continue for one year,” said Dr. Zenker.
Pre-clinical and preliminary clinical data demonstrate that vagus nerve stimulation has a therapeutic role in treating heart failure as it may harness the beneficial effects of parasympathetic stimulation, as well as reduce the heart rate and ventricular volumes. The CardioFit system has also been found to provide the same benefit when used simultaneously with other existing optimal medical therapies.
“It is the position of our team that CardioFit™ has the potential to dramatically affect the future treatment protocol for advanced congestive heart failure patients. We have been following the progress of this current trial and are pleased to now actively be a part of it,” said Professor Hasenfuss.
In addition to Göttingen, the BioControl study is now in progress at the following prestigious IRB approved sites in Europe: Policlinico S.Matteo University Hospital in Pavia, Italy; Ospedali Riuniti di Bergamo in Italy; Otto-von-Guericke University Hospital in Magdeburg, Germany; University Hospital Heidelberg at Mannheim in Germany; University Hospital Maastricht, in Maastricht, Netherlands; and the Clinical Center of Serbia in Belgrade, Serbia. The study will enroll 30+ patients.
About BioControl
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 on how to enroll in the CardioFit study, please contact: info@biocontrol-medical.com. To schedule an interview with BioControl CEO Dr. Ehud Cohen, please contact Marjie Hadad, media liaison, at +972-54-536-5220 or send an e-mail to marjie@biocontrol-medical.com or pr@marjiehadad.com.
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