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201106564a en dbs_combined_comarketing_final_11_7_13[1]

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  • "The window of opportunity" is when DBS Therapy can do the most good to help control your symptoms.
  • Transcript

    • 1. Co-sponsored by: (Insert clinic or hospital logo) and
    • 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.
    • 6. Window of Opportunity for
    • 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

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