Biocontrol Medical gets FDA approval to begin second phase of INOVATE-HF study of its CardioFit system

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The US Food and Drug Administration (FDA) has given approval to Biocontrol Medical to begin the second phase of INOVATE-HF (Increase of vagal tone in heart failure), a global, multicentre, investigational device exemption (IDE) clinical study of the company’s CardioFit system for heart failure.

The approval, which is based on the successful completion of an initial phase involving 50 patients at 21 centres worldwide, allows unconditional study expansion of up to 200 patients at 50 US centres.


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.1


“INOVATE-HF is an important study that may lead to an entirely new approach for treating congestive heart failure,” said Gregory Ewald, INOVATE-HF principal investigator at Washington University School of Medicine, USA. “We have long known that an early marker of heart failure is an imbalance in the autonomic nervous system and that this imbalance contributes to HF morbidity and mortality, but we’ve only been able to treat one side of the problem using prescription medications. If the study of the CardioFit proves successful, this may be key to understanding how to treat and prevent the progression of HF.”


INOVATE-HF is designed to explore the CardioFit’s potential to help treat one of the hallmarks of heart failure: 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 heart failure, 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 heart failure symptoms and reversing heart failure deterioration. It operates by stimulating the vagus nerve on the right side of the neck.


INOVATE-HF will ultimately enrol up to 650 patients at up to 80 centres in the United States and Europe. Results of the INOVATE-HF study will be used to support a premarket approval application to the FDA for market clearance of CardioFit.


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.1 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.


References


1 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.


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.

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