YEHUD, Israel & NEW HOPE, Minn.–(BUSINESS WIRE)–May 13, 2013–BioControl Medical has unveiled a new corporate website that offers patients, family and clinicians a valuable educational resource on its CardioFit therapy for heart failure (HF), as well as the INOVATE-HF (INcrease Of VAgal TonE in Heart Failure) investigational device exemption (IDE) clinical study of the device. Located at www.biocontrol-medical.com, the site features graphics, video, animation and text that explain the underlying physiology behind HF, how CardioFit was designed to address unsolved clinical needs in the treatment of the condition, and how the safety and efficacy of the device are being explored in INOVATE-HF.
“Vagus nerve stimulation has been used to treat epilepsy and depression for years, but BioControl Medical is the first medical technology company to explore its use in the treatment for heart failure with our CardioFit VNS device,” said Ehud Cohen, Ph.D., chief executive officer of BioControl Medical. “As pioneer of this new therapeutic area, we have a responsibility to offer patients, families and the clinical community educational resources about the technology, its potential for treating heart failure, and how they may be able to participate in the INOVATE-HF study.” On the new site, visitors can learn more about how INOVATE-HF is designed to explore the CardioFit’s potential to help treat one of the hallmarks of HF: an imbalance in the autonomic nervous system, which regulates involuntary bodily functions including heart muscle activity. In healthy individuals, the two branches of the autonomic nervous system, called the sympathetic and the parasympathetic, work in concert to regulate the heart. At the most basic level, the sympathetic increases cardiovascular activity, while the parasympathetic decreases it. In people with HF, the balance between these two branches is disrupted, leading to added stress on the heart and progressive deterioration of cardiovascular function.
While prescription medications have been successful at treating the sympathetic branch to reduce select symptoms, there have been no treatments designed to specifically and safely target the parasympathetic branch. CardioFit was developed to activate the parasympathetic nervous system directly to reduce stress on the heart, thereby alleviating HF symptoms and reversing HF deterioration. It operates by stimulating the vagus nerve on the right side of the neck.
About the CardioFit
The CardioFit system consists of a stimulator, a sensor lead and a stimulation lead, which are implanted under the skin of the chest. The sensor lead is extended from the stimulator to the right ventricle of the heart, and the stimulation lead is extended from the stimulator to the vagus nerve on the right side of the neck. Once activated, the stimulator’s electrical pulses are transferred via the stimulation lead to the vagus nerve. At the same time, the sensor lead monitors changes in heart activity and turns stimulation on or off accordingly. Like a pacemaker, the CardioFit System can be programmed on and off via external wireless communication with the device.
The safety and performance of the CardioFit have been validated in a 32-patient, multi-center, pilot clinical study conducted in Germany, Italy, The Netherlands and Serbia. Study data showed that patients experienced sustained significant improvement across key clinical measures including left ventricular function and structure, heart rate variability, and resting heart rate. Patients also showed improvement in self-reported quality of life surveys and six-minute hall walk tests. The results of this pilot study supported BioControl Medical’s filing for CE mark certification to market and sell CardioFit in the European Union, which it was granted in December 2008.
About BioControl Medical
Headquartered in Yehud, Israel with offices in New Hope, Minn., BioControl Medical 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 BioControl Medical, visit www.biocontrol-medical.com.
