2. You've taken an important first step
against your disease.
Now it's time to know more.
• What is Medtronic DBS Therapy
(deep brain stimulation)?
• How does DBS Therapy work?
• When is it time to take action?
• What are the benefits and risks?
• What can I expect from the surgical
procedure and therapy adjustments?
• Is DBS Therapy covered by
insurance?
3. : Relief Without
More Medication
• A small pacemaker-like device sends
electronic signals to an area in the brain
that controls movement.
• These signals block some of the brain
messages that cause annoying and disabling
motor symptoms.
• DBS Therapy may give you greater control
over your body movements. Many people find
this therapy helps them get back to enjoying
some of the things in life they thought they
had lost forever.
4. How DBS Works
Note: The FDA has approved Medtronic DBS Therapy to treat symptoms of Essential Tremor with stimulation
to just one side of the brain.
5. Take Action When
Can Be
Most Effective
• The right time for DBS Therapy for
Parkinson’s disease is when your
medications are not as effective as they
used to be, but before your symptoms
stop responding to medications.
• This time period is called the "window
of opportunity.”
• You and your doctor can best determine
your individual window
of opportunity.
“At night I had to
button my shirt buttons
and tie my tie in
preparation for the
morning, because my
meds didn’t kick in
before I needed to
be dressed.”
− Perry C.
7. Treats Tremors and More
DBS Therapy has been approved by the FDA to treat
movement symptoms of Parkinson’s:
• Shaking
• Stiffness
• Difficulty moving
8. Maintains Improvement of Troubling
Motor Symptoms in Parkinson’s Disease
for the Long Term
1. Krack P, Batir A, Van Blercom, et al. Five-year follow-up of bilateral stimulation of the subthalamic nucleus in
advanced Parkinson's disease. NEJM. 2003;349;1925-1934.
9. 5 More Hours Symptom-Free*
When added to medication, Medtronic DBS Therapy:
• provides 5 more hours of symptom-free* time per day
without unpredictable movements (dyskinesia).1
• will not add to your current medication routine because it
does not contain medication.
• may enable your doctor to reduce your medication doses,
which may result in fewer drug-induced side effects.
*In this presentation, symptom-free refers to on-time without troublesome dyskinesia.
1Medtronic
DBS Therapy Clinical Summary, 2009.
10. What Would You Do With 5 Extra
Symptom-Free* Hours Every Day?
For many people with Parkinson’s disease, DBS Therapy helped
them return to favorite hobbies, work, and day-to-day activities.
*In this presentation, symptom-free refers to on-time without troublesome dyskinesia.
11. Benefits of Adding
Medications Alone Medtronic DBS Therapy + Medications
0 hours of additional Average 5.1 hours additional
symptom-free* time1 symptom-free* time
Unpredictable More predictable
Uncontrollable movements (dyskinesias) Medication reduction may lead to fewer
and nonmotor side effects drug-induced side effects1
Intermittent drug doses result in peaks Delivery of DBS Therapy is constant,
and valleys of symptom relief resulting in more continuous symptom relief
Drug delivery may be slowed by No absorption required for DBS Therapy
digestive tract absorption
Some drug may be blocked by the DBS Therapy is delivered directly to a target
blood-brain barrier in the brain
1Medtronic
DBS Therapy Clinical Summary, 2009.
Note: Mean results; DBS is adjunctive to medications.
*In this presentation, symptom-free refers to on-time without troublesome dyskinesia.
12. You may benefit from Medtronic DBS
Therapy for Essential Tremor if:
• you experience uncontrollable shaking (tremor) in your hand
or arm.
• your medications are ineffective in controlling your tremor, or
you experience troubling side effects from the medications
(sleepiness, dizziness, or thinking problems).
• you experience difficulty with daily activities, such as eating,
drinking, or writing.
13. DBS Treats Tremor
Effectively
• Improvement in activities of
daily living
• Reduction in tremor
• Improvement in disability
(as reported by individuals
receiving DBS Therapy for
Essential Tremor)
Medtronic DBS Therapy
Clinical Summary, 2009.
“DBS Therapy has
allowed me to work
in a healthcare setting,
to have my own family,
and to not be reliant
on other people.”
− Kristen E.
14. Established Therapy for
More Than 25 Years
DBS Therapy may be new to you, but
it’s been helping people across the
world for more than 25 years.
More than 100,000 individuals have
received Medtronic DBS Therapy for
Parkinson’s disease, essential tremor,
or dystonia.*
*Humanitarian Device: The effectiveness
of this device for the treatment of
dystonia has not been demonstrated.
“I can drink
a glass of water
without spilling.”
– Iris C.
15. Keeps Your Future Options open
• DBS Therapy will not reduce your future therapy options.
The device can be removed (unlike other surgical options).
• You can continue medications. Down the road, you can take
advantage of new treatments, or even a cure.
16. What are the Safety Considerations
Associated with
?
The majority of serious side effects with Medtronic DBS Therapy are procedure-related
and temporary.1
•When surgical complications do occur, they are generally short-lived and most often resolved.
•Possible surgical risks may include serious complications such as coma, bleeding inside the brain,
seizures, and infection. Some of these may be fatal.
•Possible device complications include parts wearing through the skin, problems with the lead or
lead-extension connector moving, or an interruption in therapy because of mechanical or electrical
problems. Any of these situations may require additional surgery or cause your symptoms to return.
•Side effects related to stimulation may include worsening of some motor symptoms or speech or
language impairments. Typically, these side effects are not permanent and can be resolved by
adjusting stimulation parameters. Depression, suicidal thoughts, and suicide have been reported.
Occurrence of falls has also been observed.
•Medtronic DBS systems are designed so that an MRI head scan is possible under specific conditions
of use.
•For complete safety information about Medtronic DBS Therapy, talk to your doctor, call Medtronic
toll-free at 1-800-328-0810, or visit www.refusetosurrender.com.
1Medtronic
DBS Therapy Clinical Summary, 2009.
17. Davis Phinney’s Victory
• Davis’ passion and energy
fueled his cycling success.
− World champion cyclist
− Olympic medal winner
• Years later, Davis refused to
surrender to his PD diagnosis.
− Davis fought his early-onset
PD with determination and
DBS Therapy.
“The gift (of DBS
Therapy) is just the
absolute joy you get
out of being able to
do the simplest
things in life again.”
− Davis Phinney
18. Celebrating Daily Victories
This is the experience of one individual who is receiving Medtronic DBS Therapy for Parkinson's disease. Medtronic invited this individual to
tell his story, and his treatment results are specific to him. Not everyone who receives Medtronic DBS Therapy will experience the same
results. Some people may experience significant symptom relief from DBS Therapy, and others may experience minimal relief. Talk to your
doctor to see if Medtronic DBS Therapy is right for you.
19. Watch DBS in Action
Parkinson’s Disease
This is the experience of one individual who is receiving Medtronic DBS Therapy for Parkinson's disease. Not everyone who receives
Medtronic DBS Therapy will experience the same results. Some people may experience significant symptom relief from DBS Therapy, and
others may experience minimal relief. Talk to your doctor to see if Medtronic DBS Therapy is right for you.
20. Watch DBS in Action
Essential Tremor
This is the experience of one individual who is receiving Medtronic DBS Therapy for Essential Tremor. Not everyone who receives
Medtronic DBS Therapy will experience the same results. Some people may experience significant symptom relief from DBS Therapy, and
others may experience minimal relief. Talk to your doctor to see if Medtronic DBS Therapy is right for you.
21. A Well-Planned Surgical Procedure
Receiving Medtronic DBS Therapy typically involves the
following steps:
• Brain Imaging
• Brain Mapping
• DBS Lead Placement
• Neurostimulator Placement
• Therapy Activation
22. Programming Sessions
• Initial programming takes place 2 to 4 weeks after surgery
• Adjustments in the first 3 months
• Periodic programming adjustments to be performed
by your neurologist
Actual patient not pictured.
23. Insurance Coverage
• Medtronic DBS Therapy for Parkinson’s disease is covered by
many insurance companies and Medicare.
• Typically, your doctor who is doing the procedure will work with
your insurance company to request and obtain prior approval for
the procedure.
• Occasionally, an insurance company may deny a request for prior
approval of the procedure if it is unfamiliar with the treatment.
• If you receive a denial and wish to appeal, please work with
your doctor.
• You may also contact Medtronic Coverage and Authorization
Services at 1-800-292-2903 for help.
24. Speak Up and Be Active
In Your Treatment
• The earlier you discuss DBS Therapy
with a specialist, the better.
• For Parkinson’s disease, there is a
window of opportunity when the
therapy may be most effective.
– The optimal time to seek advice from a
specialist is 3 to 5 years after a Parkinson’s
diagnosis.
– As Parkinson’s disease progresses,
the positive impact of therapy will be
more limited.
– It’s especially important to
seek out a DBS specialist
“I used to paint
as soon as you notice
quite a bit, and then
I had to stop. After my
a change in the way
surgery, I painted
your body responds
each of my doctors
to oral medications.
a picture.”
− Wanda M.
25. Is
Right For You?
Learn more about Medtronic
DBS Therapy with the
Support LinkSM Program.
• Call Medtronic at 1-877-438-3574.
• Visit www.refusetosurrender.com.
“I couldn’t just
sit back. I was
going to fight that
disease by learning
everything I could
about my disease.””
− Kirk H.
26. Brief Summary Disclosure: Medtronic DBS Therapy for
Parkinson’s Disease, Tremor, and Dystonia
Medtronic DBS Therapy for Parkinson’s Disease, Tremor and Dystonia: Patients should always discuss the potential risks
and benefits with a physician.
Indications:
Medtronic DBS Therapy for Parkinson’s Disease: Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic
nucleus (STN) using Medtronic DBS Therapy for Parkinson’s Disease is indicated for adjunctive therapy in reducing some of the
symptoms of advanced, levodopa-responsive Parkinson’s disease that are not adequately controlled with medication.
Medtronic DBS Therapy for Tremor: Unilateral thalamic stimulation using Medtronic DBS Therapy for Tremor is indicated for the
suppression of tremor in the upper extremity. The system is intended for use in patients who are diagnosed with Essential Tremor or
Parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. The
safety or effectiveness of this therapy has not been established for bilateral stimulation.
Medtronic DBS Therapy for Dystonia: Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic
nucleus (STN) using Medtronic DBS Therapy for Dystonia is indicated as an aid in the management of chronic, intractable (drug
refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for
individuals 7 years of age and older.
Contraindications:
Contraindications include patients who will be exposed to MRI using a full body radio-frequency (RF) coil or a head transmit coil that
extends over the chest area, patients who are unable to properly operate the neurostimulator, or for Parkinson’s disease and Essential
Tremor, patients for whom test stimulation is unsuccessful. Also, diathermy (e.g., shortwave diathermy, microwave diathermy or
therapeutic ultrasound diathermy) is contraindicated because diathermy's energy can be transferred through the implanted system (or
any of the separate implanted components), which can cause neurostimulation system or tissue damage and can result in severe injury
or death. Transcranial Magnetic Stimulation (TMS) is contraindicated for patients with an implanted DBS System.
Warnings/Precautions/Adverse Events:
There is a potential risk of tissue damage using stimulation parameter settings of high amplitudes and wide pulse widths. Extreme care
should be used with lead implantation in patients with a heightened risk of intracranial hemorrhage. The lead-extension connector
should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. Theft detectors and security
screening devices may cause stimulation to switch ON or OFF, and may cause some patients to experience a momentary increase in
perceived stimulation. Although some MRI procedures can be performed safely with an implanted DBS System, clinicians should
carefully weigh the decision to use MRI in patients with an implanted DBS System. MRI can cause induced voltages in the
neurostimulator and/or lead possibly causing uncomfortable, jolting, or shocking levels of stimulation.
27. Brief Summary Disclosure: Medtronic DBS Therapy for
Parkinson’s Disease, Tremor, and Dystonia (continued)
The DBS System may be affected by or adversely affect medical equipment such as cardiac pacemakers or therapies, cardioverter/
defibrillators, external defibrillators, ultrasonic equipment, electrocautery, or radiation therapy. Safety and effectiveness has not been
established for patients with neurological disease other than Parkinson’s disease or Essential Tremor, previous surgical ablation
procedures, dementia, coagulopathies, or moderate to severe depression; or for patients who are pregnant, under 18 years, over 75
years of age (Parkinson’s Control Therapy) or over 80 years of age (Tremor Control Therapy). For patients with Dystonia, age of
implant is suggested to be that at which brain growth is approximately 90% complete or above. Depression, suicidal ideations and
suicide have been reported in patients receiving Medtronic DBS Therapy for Movement Disorders, although no direct cause and effect
relationship has been established.
Abrupt cessation of stimulation should be avoided as it may cause a return of disease symptoms, in some cases with an intensity
greater than was experienced prior to system implant (“rebound” effect). Adverse events related to the therapy, device, or procedure
can include: stimulation not effective, cognitive disorders, pain, dyskinesia, dystonia, speech disorders including dysarthria, infection,
paresthesia, intracranial hemorrhage, electromagnetic interference, cardiovascular events, visual disturbances, sensory disturbances,
device migration, paresis/asthenia, abnormal gait, incoordination, headaches, lead repositioning, thinking abnormal, device explant,
hemiplegia, lead fracture, seizures, respiratory events, and shocking or jolting stimulation. Patients using a rechargeable
neurostimulator for Parkinson’s Control Therapy or Tremor Control Therapy should check for skin irritation or redness near the
neurostimulator during or after recharging, and contact their physician if symptoms persist.
Humanitarian Device (Dystonia):
Authorized by Federal Law for the use as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including
generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for individuals 7 years of age and older. The
effectiveness of this device for this use has not been demonstrated.
Rev 1212
UC201106564a EN
USA Rx only
Editor's Notes
"The window of opportunity" is when DBS Therapy can do the most good to help control your symptoms.