On 13 May, BioControl Medical introduced a new corporate website that offers patients, family and clinicians an educational resource on its CardioFit therapy for heart failure, as well as the INOVATE-HF (Increase of vagal tone in heart failure) investigational device exemption (IDE) clinical study of the device.
The site explains the underlying physiology behind heart failure, 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, 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.”
In the United States, the CardioFit is an investigational device.
About the CardioFit
CardioFit was developed to activate the parasympathetic nervous system directly to reduce stress on the heart, thereby alleviating heart failure symptoms and reversing the disease deterioration. It operates by stimulating the vagus nerve on the right side of the neck.
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, multicentre, 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 the CE mark of the device obtained in December 2008.