Download At The Heart Of It All

We are seeking participants in a clinical trial
to determine the safety and benefits of a new
approach to treating heart failure.
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H e a r t
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CA U TI O N : Investigational Device. Limited by Federal
(or United States) law to investigational use.
At the Heart of it all
A New Approach to Heart Failure
If you have heart failure, you are not alone. It is the fastest
growing cardiovascular disorder in the US, and heart failure
affects about 23 million people worldwide.1
The brain helps to control the function of the heart through two
branches. The sympathetic branch activates the “fight or flight”
response during stress, increasing heart rate and blood pressure.
The parasympathetic branch has a calming effect on the heart
through signals carried from brain to the heart by the vagus nerve.
Normally, the two branches are in “balance”.
In heart failure, however, there is an imbalance.
The sympathetic branch is in overdrive while the
parasympathetic branch is underactive. Some heart failure
medications help to “slow down” the sympathetic branch,
but currently there are no proven treatments that help the
underactive parasympathetic branch. Like driving a car,
easing up on the accelerator (sympathetic) will slow down
the car a bit, but stepping on the brake (parasympathetic)
will reduce the speed more quickly.
1 Congestive Heart Failure: Worldwide Drug and Medical Device Market—Kalorama Information available through
MarketResearch.com
w w w . b i o c o n t r o l - m e d i c a l . c o m 2
At the Heart of it all
The CardioFit ® System
The CardioFit ® system from BioControl Medical is the first
device designed to increase the effect of the parasympathetic branch
to help bring better balance to the heart. The system was tested in a
European study of people with heart failure.2
Three Main Components of the CardioFit ® System
1. The stimulation lead is a
flexible, insulated wire that
transmits electrical signals
from the stimulator to the
vagus nerve.
stimulation
lead
2. The stimulator is similar
to a pacemaker, and contains
the electronics of the system
in a small sealed case. It is
implanted under the skin in
the upper chest.
3. A standard pacemaker lead
is passed through a vein into
a lower chamber of the heart.
It is connected to the stimulator,
and senses the heartbeat.
stimulator
standard
pacemaker lead
2 De Ferrari GM, Crijns HJ, Borggrefe M, et al. Chronic vagus nerve stimulation: a new and promising therapeutic approach
for chronic heart failure. Eur Heart J. 2010; 32(7):847-55
B i o C o n t r o l M e d i c a l 3
The INOVATE-HF Study
The INOVATE-HF clinical study will compare the
safety and effectiveness of the CardioFit ® system
plus optimal medical therapy to optimal medical
therapy alone for the treatment of heart failure.
The study is seeking up to 650 adult men and
women with diagnosed heart failure at selected
medical centers in the United States and Europe.
The investigators are doctors who specialize
in treating heart failure and in managing
cardiac devices.
Potential candidates are being treated with
a combination of medications, but still
have symptoms such as shortness of breath
and fatigue.
i n o v a t e h f @ b i o c o n t r o l - m e d i c a l . c o m 4
Five Steps of the INOVATE-HF Study
1. Evaluation
Includes a complete physical examination,
questionnaires, and tests to check your
overall health status.
2. Randomization
For every 5 qualifying participants, 3 will
be randomly assigned to receive the CardioFit
device and 2 to receive ongoing optimal
medical therapy.
3. Implant
Trained doctors implant the device for those
in the CardioFit group.
4. Adjustment
For the participants in the CardioFit group,
the therapy is turned on 3 to 5 weeks after
implant and is fine-tuned over a 4 week
period. Health team members adjust the
settings with a computer that communicates
with the device through an antenna placed
on the chest over the stimulator.
5. Long-term treatment
All participants visit their clinic periodically.
The visits occur every 3 months for the first
18 months, and every 6 months thereafter
until the end of the study (up to 5 1/ 2 years ).
i n o v a t e h f @ b i o c o n t r o l - m e d i c a l . c o m 5
About Clinical Research
Many new treatments may help people enjoy longer and healthier lives.
Clinical studies often compare new treatments with the current standard
of care. Strict government regulations control the conduct of clinical studies
to protect the rights and ensure the safety of the volunteers. Ideally, the
CardioFit ® system will improve heart failure symptoms and slow heart
failure progression.
While the treatment offered in this study may benefit you, there are
no guarantees. We commit to ensuring that INOVATE-HF provides
valuable information that will help create better treatments for people
with heart failure.
Clinical study participation is voluntary. Make sure your doctor answers
all your questions and explains the potential risks and benefits.
How to Participate in INOVATE-HF
If you or someone in your family has heart failure, the INOVATE-HF
study may be of interest. Talk to your doctor about the possibility
of participating.
INOVATE-HF is sponsored by BioControl Medical with funding from strategic
partner Medtronic.
9220 Bass Lake Road, Suite 255, New Hope, MN 55428
T: 1-877-494 -8770 | F: 1-763-210 - 5300
inovatehf @ biocontrol-medical.com | www.biocontrol-medical.com
© BioControl Medical 2012
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