What to expect with VNS Therapy

What to expect
®
with VNS Therapy
Adey,
On VNS Therapy since 2004
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What to expect with VNS Therapy®
Now that you have chosen to have VNS Therapy, you probably have
questions about your next steps and what to expect.
VNS Therapy is not
another medication.
It is a unique approach for difficult-to-treat epilepsy that
has been proven to reduce the number and intensity of
seizures. In addition, many people using VNS Therapy
have also reported improvements in mood, increased
alertness, and enhanced memory.
You are not alone in your decision
to get VNS Therapy. More than
65,000 people worldwide have
chosen this treatment to help
control their seizures without
the side effects often associated
with medications like depression,
dizziness, confusion, weight
changes, fatigue, insomnia,
and low energy. Many people
experience long-lasting seizure
control with VNS Therapy. It is
a safe, effective treatment that
usually improves over time.
What to expect with VNS Therapy®
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What to expect with VNS Therapy®
Understanding VNS Therapy
The vagus nerve connects the brain to various parts of the body and
has been proven to be a good way to communicate with the brain.
VNS Therapy sends messages to the brain through this nerve to help
control seizures.
A short, outpatient procedure
The implant procedure is minimally invasive and 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.
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.
What to expect with VNS Therapy®
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What to expect with VNS Therapy®
VNS Therapy is customized
to suit every individual.
The VNS Therapy generator is
usually turned on 2 weeks after
the implant procedure. 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.
During routine office visits,
your doctor can read and adjust
stimulation settings using special
computer software and a VNS
Therapy programming wand.
During each office visit, your
doctor will check to make sure the
VNS Therapy system is working
properly and the stimulation is
comfortable for you.
What to expect with VNS Therapy®
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The VNS Therapy magnet
and how it works
An added benefit of VNS Therapy is the handheld VNS Therapy magnet.
If you or your caregiver recognizes that you are having a seizure or are
about to have a seizure, the 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.
Holding the magnet over the place where the generator is located
for at least two seconds is all it takes. An extra dose of stimulation
will begin when you move the magnet away from the generator. The
magnet can be conveniently worn on your belt or wrist like a watch.
Your doctor or nurse will show you how to use the magnet and
answer any questions you may have.
Before you can use the VNS Therapy magnet, your doctor
must adjust a setting on the generator. This will happen
during your first programming appointment.
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What to expect with VNS Therapy®
Replacing the VNS Therapy
generator battery
The VNS Therapy generator
battery usually lasts 5-8 years,
but can change depending on
the device settings. A procedure
is required to replace the
generator once the battery is
depleted. The procedure to
replace the battery requires only
one incision, is also typically
done on an outpatient basis,
and takes less than an hour.
Common side effects
of VNS Therapy
The most common side effects of
VNS Therapy may include a feeling
of 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
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What to expect with VNS Therapy®
these side effects during activities
such as public speaking, singing,
or exercising if needed. If you
experience troublesome or painful
side effects from VNS Therapy for
an extended period of time, you
should contact your doctor. There
is a minor risk of infection from
the implantation procedure, which
is similar to any other minimally
invasive procedure.
Precautions with VNS Therapy
• Talkwithyourdoctorbeforeyouhaveanymedicalteststhatmight
affect, or be affected by, the VNS Therapy system. If you’re unsure,
always ask your doctor.
• T alkwithyourdoctorbeforeyouhaveanyothermedicaldevices
implanted.
• T ellyourdoctorifyounolongerfeeltheroutinestimulation.Your
doctor may decide to change the generator settings.
• PeoplewithVNSTherapyshouldnotuseshort-wavediathermy,
microwave diathermy, or therapeutic ultrasound diathermy. Be sure to
inform any healthcare professional that you should not have diathermy
treatment.
• P eoplewithVNSTherapymusttakespecialprecautionsbeforehaving
an MRI (Magnetic Resonance Imaging) scan. Talk with your doctor
before having an MRI.
• B
eforeundergoinganymedicalprocedure,notifyyourhealthcare
provider that you have VNS Therapy.
A full list of warnings and precautions are included in the Patient’s Manual
in your kit, or available on our website at www.VNSTherapy.com.
What to expect with VNS Therapy®
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Your VNS Therapy checklist
As you move forward with VNS Therapy, the following steps
are important.
Make sure your insurance coverage has been
authorized
•Askyourdoctor
Get pre-operation instructions
•Askyoursurgeon
Schedule a follow-up visit with your surgeon
•Makeanappointmenttovisityoursurgeonafterthe
implantation procedure
•Askaboutpost-operativeinstructions
Schedule a follow-up visit with your neurologist
•Makeanappointmenttovisityourneurologistafterthe
implantation procedure
Take your Patient Essentials Kit home from the
hospital along with your post-operative instructions
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•ThePatientEssentialsKitcontainsyourPatient’sManual,
VNS Therapy handheld magnets, and a wallet-sized Patient
EmergencyCard
•Tellyourdoctorimmediatelyifyoudonotreceiveyourkitat
the hospital
What to expect with VNS Therapy®
Talk to someone who has
VNS Therapy.
Join our monthly Phone Facts conference call to 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.
You can also join us on Facebook
www.facebook.com/ VNSTherapyforEpilepsy
What to expect with VNS Therapy®
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Safety Information for
VNS Therapy
INTENDEDUSE/INDICATIONS—UNITEDSTATES
Epilepsy:TheVNSTherapySystemisindicatedforuseasanadjunctivetherapyinreducing
the frequency of seizures in adults and adolescents over 12 years of age with partial onset
seizures which are refractory to antiepileptic medications.
CONTRAINDICATIONS
The VNS Therapy System cannot be used in patients after a bilateral or left cervical
vagotomy. Do not use short-wave diathermy, microwave diathermy, or therapeutic
ultrasound diathermy on patients implanted with The VNS Therapy System.
Diagnostic ultrasound is not included in this contraindication. Injury or damage can occur
during diathermy treatment whether The VNS Therapy System is turned “ON” or “OFF.”
WARNINGS
Physicians should inform patients about all potential risks and adverse events
discussed in The VNS Therapy System Physician’s Manual including information that VNS
Therapy may not be a cure for epilepsy. Since seizures may occur unexpectedly, patients
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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What to expect with VNS Therapy®
Patients who have pre-existing swallowing, cardiac, or respiratory difficulties (including,
but not limited to, obstructive sleep apnea and chronic pulmonary disease) should
discuss with their physicians whether VNS Therapy is appropriate for them since there is
the possibility that stimulation might worsen their condition. Patients with The VNS Therapy
System or any part of The VNS Therapy System implanted should not have a full body MRI.
PRECAUTIONS
The safety and efficacy of The VNS Therapy System has not been established for use
during pregnancy. Patients who smoke may have an increased risk of laryngeal irritation.
ADVERSEEVENTS
The most commonly reported side effects from stimulation include hoarseness (voice
alteration), paresthesia (prickling feeling in the skin), dyspnea (shortness of breath), sore
throat and increased coughing. These typically occur only during stimulation, are well
tolerated and noticed less as time goes on. The most commonly reported side effect from
the implant procedure is infection.
*THEINFORMATIONCONTAINEDINTHISSUMMARYREPRESENTSPARTIALEXCERPTS
OFIMPORTANTPRESCRIBINGINFORMATIONTAKENFROMTHEPRODUCTLABELING.
THEINFORMATIONISNOTINTENDEDTOSERVEASASUBSTITUTEFORACOMPLETE
ANDTHOROUGHUNDERSTANDINGOFTHEVNSTHERAPYSYSTEMNORDOESTHIS
INFORMATIONREPRESENTFULLDISCLOSUREOFALLPERTINENTINFORMATION
CONCERNINGTHEUSEOFTHISPRODUCT.(CAUTION—U.S.FEDERALLAWRESTRICTS
THISDEVICETOSALEBYORONTHEORDEROFAPHYSICIAN.)
What to expect with 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.
PtExp13-11-2000-US