April 3, 2013 — BioControl Medical has received U.S. Food and Drug Administration (FDA) approval to begin the third and largest phase of INOVATE-HF (INcrease Of VAgal TonE in Heart Failure), a global, multi-center, investigational device exemption (IDE) clinical study of the company’s CardioFit system for heart failure. The approval, which is based on the FDA’s safety review of the first two successful completed phases, allows unconditional study expansion to full enrollment of 650 patients at 80 centers worldwide.
Initiated in April 2011, INOVATE-HF is a prospective, randomized, 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 (HF). The study will evaluate the system’s potential to reduce hospitalization and death among patients with HF, while also exploring whether combined treatment with CardioFit and prescription drug therapy is more effective than drug therapy alone.
“The scientific evidence supporting CardioFit dates back to our 32-patient European pilot study, which was recently hailed as seminal original research in an editorial of the European Journal of Heart Failure,” said Ehud Cohen, Ph.D., chief executive officer of BioControl Medical. “FDA’s recent approval of the final phase of INOVATE-HF is a significant milestone that will enable us to rigorously evaluate the system in a very broad global patient population and puts us one step closer to making CardioFit available to physicians and patients across the United States.”
Results of the INOVATE-HF study will be used to support a Premarket Approval Application (PMA) to the FDA for market clearance of CardioFit.
“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.”
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.
For more information: www.biocontrol-medical.com
In the United States, the CardioFit is an investigational device.
1 Luscher, TF, et al. “The European Heart Journal and the European Journal of Heart Failure: partners in scientific publishing.” European Journal of Heart Failure (2012) 14, 1075–1082