U.S. Food and Drug Administration Approves Full Expansion of BioControl Medical’s INOVATE-HF Study of the CardioFit®
YEHUD, Israel & NEW HOPE, Minn.--(BUSINESS WIRE)--Mar 26, 2013--BioControl Medical has received U.S. Food and Drug Administration 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. 1 “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 1,” 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 U.S. Food and Drug Administration (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 Dr. 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.
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. 2 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. 2 Patients also showed improvement in self-reported quality of life surveys and six-minute hall walk tests. 3 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.
Caution: In the United States, the CardioFit is an investigational device. Limited by Federal (or United States) law to investigational use.
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
2 De Ferrari GM, Crijns HJ, Borggrefe M, Milasinovic G, Smid J, Zabel M, Gavazzi A, Sanzo A, Dennert R, Kuschyk J, Raspopovic S, Klein H, Swedberg K, Schwartz PJ. “Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure.” Eur Heart J (2011) 32 (7): 847-855.
3 Hauptman PJ, Schwartz PJ, Gold MR, Borggrefe M, Van Veldhuisen DJ, Starling, RC, Mann DL. “Rationale and study design of the INcrease Of Vagal TonE in Heart Failure study: INOVATE-HF.” American Heart Journal (June 2012) 163 (6): 955-962.