Is VNS Therapy® right for you?

Is VNS Therapy
right for you?
®
Evaluate your treatment and your options
Kristof,
On VNS Therapy since 2006
You are not alone.
At this point you probably have many questions about the best treatment
options going forward. It may be that, although you’ve taken your
medicine and followed your doctor’s advice, your seizures haven’t eased
up or stopped. This is called drug-resistant epilepsy and you are not alone.
Drug-resistant epilepsy means your seizures have not been controlled even
after trying multiple appropriate treatments. About one in three people
(approximately 35%) with epilepsy experience this type of epilepsy that is
difficult to treat with medications.
Years of medical research tell us
that if two or three drugs have not
given you seizure freedom, there’s
very little chance of gaining seizure
freedom with any additional drugs.
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Is VNS Therapy® right for you?
If multiple medications have not
provided you with acceptable,
ongoing seizure relief, it may be
time to discuss different treatment
options with your doctor.
Is VNS Therapy® right for you?
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How does your treatment
treat you?
It is important to evaluate your current epilepsy treatment and the way it
affects your life. If you can answer “yes” to any of these questions, it may
be time to talk to your doctor about treatment options beyond medication.
• A
re you taking multiple
medications for seizure control
and still having seizures?
• A
re you experiencing side
effects from your current
treatments that interfere with
your daily activities?
• H
ave you repeatedly been to the
emergency room or admitted
to the hospital because of your
seizures or seizure-related injuries?
• D
oes the time it takes you to
recover from your seizures stop
you from continuing with your
daily activities?
We understand that treatment is not just about seizure
control. The goal of your treatment should be to help
you improve seizure control with the fewest side effects
so you can have the best possible quality of life.
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Is VNS Therapy® right for you?
Is VNS Therapy® right for you?
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You have another option.
A unique treatment approach is VNS (Vagus Nerve Stimulation) Therapy.
More than 65,000 people worldwide have chosen VNS Therapy to help
control their seizures without the side effects often associated with
medications like depression, dizziness, confusion, weight changes, fatigue,
insomnia, and low energy.
VNS Therapy is not another
medication. It has been
proven to reduce the number
and intensity of seizures.
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Is VNS Therapy® right for you?
In addition, many people using
VNS Therapy have also reported
improvements in mood, increased
alertness, and enhanced memory.
It is a safe, effective treatment that
improves over time. Many people
experience long-lasting seizure
control with VNS Therapy.
Is VNS Therapy® right for you?
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About VNS Therapy
The vagus nerve connects the brain to various parts of
the body. VNS Therapy sends messages to the brain
through this nerve to help control seizures.
It’s important to understand that VNS Therapy does not involve brain
surgery. The minimally invasive procedure is typically performed under
general anesthesia by a surgeon. A small generator about the size of a
watch is placed under the skin usually in the chest area. A thin, flexible
wire connects the generator to the vagus nerve in the neck which delivers
periodic pulses directly to the brain. The procedure takes about an hour
and most people go home the same day.
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Is VNS Therapy® right for you?
Is VNS Therapy® right for you?
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VNS Therapy is customized
to suit every individual.
Your doctor programs the generator to automatically deliver the
appropriate dose of stimulation for you. One dose commonly used by
physicians is 30 seconds of stimulation every 5 minutes.
In addition to the comfort of having treatment automatically delivered,
VNS Therapy may provide you with added control. If you or your caregiver
recognizes that you are having a seizure or are about to have a seizure,
a handheld VNS Therapy magnet allows you to immediately activate
an additional dose of stimulation so that it potentially shortens, stops,
decreases the intensity, or decreases the recovery period of the seizure.
Use of the magnet is not necessary to receive VNS Therapy.
The most common side effects of VNS Therapy may include hoarseness
or changes in voice tone, coughing, a tickling sensation in the throat
or on the neck, and a feeling of shortness of breath. These side effects
generally occur only when the generator is on and usually decrease over
time. The magnet can be used to turn off the generator to temporarily
control these side effects during activities such as public speaking,
singing, or exercising.
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Is VNS Therapy® right for you?
Is VNS Therapy® right for you?
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How do you learn more
about VNS Therapy?
If you would like to know whether you can benefit from VNS Therapy,
there are a number of ways to learn more:
1. Talk to your neurologist about whether VNS Therapy is right for you.
2.Call a VNS Therapy nurse case manager toll-free at 1-888-867-7846.
He or she can answer questions about VNS Therapy and also help you
with insurance and payment questions. VNS Therapy is covered by
many insurance plans, including Medicare and Medicaid.
3.Join our monthly Phone Facts conference call and talk with VNS
Therapy patients and other people thinking about getting VNS
Therapy. On this call, you can get firsthand information about the
procedure and learn what it feels like to have VNS Therapy. An
epilepsy specialist is available for every session. You do not have to
provide your name, even if you wish to ask questions. All calls are
free and confidential.
Calls take place the first Tuesday of every month, 7:00 PM Central
Standard Time: 1-877-451-8943.
4.Visit www.VNSTherapy.com
You can also join us on Facebook
www.facebook.com/ VNSTherapyforEpilepsy
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Is VNS Therapy® right for you?
Is VNS Therapy® right for you?
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Safety Information for
VNS Therapy
INTENDED USE / INDICATIONS—UNITED STATES
Patients who have pre-existing swallowing, cardiac, or respiratory difficulties (including,
Epilepsy: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing
but not limited to, obstructive sleep apnea and chronic pulmonary disease) should
the frequency of seizures in adults and adolescents over 12 years of age with partial onset
discuss with their physicians whether VNS Therapy is appropriate for them since there is
seizures which are refractory to antiepileptic medications.
the possibility that stimulation might worsen their condition. Patients with The VNS Therapy
CONTRAINDICATIONS
System or any part of The VNS Therapy System implanted should not have a full body MRI.
The VNS Therapy System cannot be used in patients after a bilateral or left cervical
PRECAUTIONS
vagotomy. Do not use short-wave diathermy, microwave diathermy, or therapeutic
The safety and efficacy of The VNS Therapy System has not been established for use
ultrasound diathermy on patients implanted with The VNS Therapy System.
during pregnancy. Patients who smoke may have an increased risk of laryngeal irritation.
Diagnostic ultrasound is not included in this contraindication. Injury or damage can occur
ADVERSE EVENTS
during diathermy treatment whether The VNS Therapy System is turned “ON” or “OFF.”
The most commonly reported side effects from stimulation include hoarseness (voice
WARNINGS
alteration), paresthesia (prickling feeling in the skin), dyspnea (shortness of breath), sore
Physicians should inform patients about all potential risks and adverse events
throat and increased coughing. These typically occur only during stimulation, are well
discussed in The VNS Therapy System Physician’s Manual including information that VNS
tolerated and noticed less as time goes on. The most commonly reported side effect from
Therapy may not be a cure for epilepsy. Since seizures may occur unexpectedly, patients
the implant procedure is infection.
should consult with a physician before engaging in unsupervised activities, such as driving,
swimming, and bathing, or in strenuous sports that could harm them or others.
The safety and efficacy of The VNS Therapy System has not been established for uses
outside of its approved indications. Patients should avoid excessive stimulation (>4 hours
of continuous stimulation due to repeated magnet activations) and manipulation of the
Pulse Generator and Lead through the skin. A malfunction of The VNS Therapy System
could cause painful or direct current stimulation. Removal of The VNS Therapy System
requires an additional surgical procedure.
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Is VNS Therapy® right for you?
*THE INFORMATION CONTAINED IN THIS SUMMARY REPRESENTS PARTIAL EXCERPTS
OF IMPORTANT PRESCRIBING INFORMATION TAKEN FROM THE PRODUCT LABELING.
THE INFORMATION IS NOT INTENDED TO SERVE AS A SUBSTITUTE FOR A COMPLETE
AND THOROUGH UNDERSTANDING OF THE VNS THERAPY SYSTEM NOR DOES THIS
INFORMATION REPRESENT FULL DISCLOSURE OF ALL PERTINENT INFORMATION
CONCERNING THE USE OF THIS PRODUCT. (CAUTION—U.S. FEDERAL LAW RESTRICTS
THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.)
Is VNS Therapy® right for you?
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Call toll-free: 1-888-VNS-STIM
8 6 7-7 8 4 6
Or visit www.VNSTherapy.com
You can also join us on
Facebook
www.facebook.com/ VNSTherapyforEpilepsy
www.cyberonics.com
CYBERONICS, INC.
100 Cyberonics Boulevard
Houston, Texas 77058
Tel: +1.800.332.1375
Fax: +1.281.218.9332
CYBERONICS EUROPE
Belgicastraat 9
1930 Zaventem, Belgium
Tel: +32.2.720.95.93
Fax: +32.2.720.60.53
©2012 Cyberonics, Inc. All rights reserved. Cyberonics® and VNS Therapy® are registered
trademarks of Cyberonics, Inc.
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