BioControl Medical has announced that the FDA has approved full expansion of the INNOVATE-HF (Increase of vagal tone in heart failure) study, which is investigating BioControl Medical’s CardioFit device for vagal nerve stimulation in patients with heart failure.
According to a company press release, following the FDA approval, BioControl Medical can now begin the third and largest phase of INOVATE-HF. The approval, which is based on the FDA’s safety review of the first two successful completed phases, allows unconditional study expansion to full enrolment of 650 patients at 80 centres worldwide.
Initiated in April 2011, INOVATE-HF is a prospective, randomised, controlled clinical study to determine the safety and efficacy of the CardioFit, an implantable electrical stimulation device designed to improve heart function in patients with congestive heart failure. The study will evaluate the system’s potential to reduce hospitalisation and death among patients with heart failure, while also exploring whether combined treatment with CardioFit and prescription drug therapy is more effective than drug therapy alone.
“While vagus nerve stimulation has been proven effective in treating epilepsy and depression, its ability to treat heart failure has not, until now, been evaluated in a large pivotal study,” said Kimberly Parks, INOVATE-HF principal investigator at Massachusetts General Hospital in Boston. “I believe INOVATE-HF is a very important clinical trial that, in addition to advancing the science behind heart failure, may ultimately lead to a breakthrough new treatment modality for patients.”
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 BioControl Medical’s filing for CE mark certification to market and sell CardioFit in the EU, which it was granted in December 2008.
Results of the INOVATE-HF study will be used to support a Premarket Approval Application (PMA) to the FDA for market clearance of CardioFit.