BioControl
Medical has announced U.S. Food and Drug Administration
approval to begin the second 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 successful
completion of an initial phase involving 50 patients at 21 centers
worldwide, allows unconditional study expansion of up to 200 patients at
50 U.S. centers.
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 FDA's approval to expand INOVATE-HF is a wonderful validation of
the excellent clinical work completed in phase one of the study," said
Ehud Cohen, Ph.D., chief executive officer of BioControl Medical. "We
applaud the efforts of our trial investigators and coordinators, who are
fundamental to driving this pioneering research, and we look forward to
working with a broader group of sites across the United States in the
near future."
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.
"INOVATE-HF is an important study that may lead to an entirely new
approach for treating congestive heart failure," said Dr. Gregory Ewald,
INOVATE-HF principal investigator at Washington University School of
Medicine. "We've long known that an early marker of HF 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 will ultimately enroll up to 650 patients at up to 80 centers
in the United States and Europe. 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.
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