Understanding more about VNS Therapy

Understanding more
®
about VNS Therapy
Erin,
On VNS Therapy since 1999
It’s perfectly understandable that you might have some questions
and concerns about changes to your treatment plan.
You are not the first
to feel this way.
About one in three people (approximately 35%) with epilepsy experience
the type of epilepsy that is difficult to treat with medications. Know,
however, that more than 65,000 people worldwide have been treated
with VNS Therapy for their difficult-to-treat epilepsy.
It’s important that you feel comfortable with your
decision to get VNS Therapy.
Understanding more about it may help to ease your concerns. A seizure
disorder should never be a barrier to living a full, happy life. The hour it
takes to have the procedure can be followed by many years of enjoying a
better life if VNS Therapy works as well for you as it has for so many others.
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Understanding more about VNS Therapy®
Understanding more about VNS Therapy®
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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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Understanding more about VNS Therapy®
Understanding more about VNS Therapy®
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VNS Therapy may improve
your quality of life.
With VNS Therapy you could experience fewer and less severe seizures
as well as shorter recovery times from your seizures. In addition, many
people using VNS Therapy have also reported improvements in mood,
increased alertness, and enhanced memory.
Because the generator is implanted under the skin, you
will have your treatment with you all the time.
This is an advantage because there’s nothing to take and no schedules to
remember. VNS Therapy is with you all day, every day, so you don’t have
to worry about it.
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Understanding more about VNS Therapy®
Understanding more about VNS Therapy®
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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
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Understanding more about VNS Therapy®
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.
Understanding more about VNS Therapy®
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Frequently Asked Questions
Q. Am I a good candidate for VNS Therapy?
A. People who continue to have seizures despite treatment with two or
more medications and have side effects that are difficult to tolerate may
benefit from adding VNS Therapy to their treatment regimen. If multiple
medications have not given you acceptable, ongoing seizure relief, it may
be time to consider a different treatment option like VNS Therapy.
Q. What is the procedure like?
A. It is a straightforward, minimally invasive procedure that is performed
under general anesthesia. It involves two small incisions: one in the chest
area and one in the crease of the neck.
Q. How long does it take?
A. The actual procedure takes about an hour. With preparation and
follow-up, most people go home the same day.
Q. What are the potential side effects?
A. 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.
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Understanding more about VNS Therapy®
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.
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?
• Are you experiencing side effects from your current treatments that
interfere with your daily activities?
• Have you repeatedly been to the emergency room or admitted to the
hospital because of your seizures or seizure-related injuries?
• Does 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.
Understanding more about VNS Therapy®
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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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Understanding more about VNS Therapy®
Understanding more about VNS Therapy®
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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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*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.)
Understanding more about VNS Therapy®
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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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