How It Feels to Be You Again

Transcription

1 How It Feels to Be You Again DBS and Parkinson s Disease: An Educational Guide for Patients Meet Pedro, a Boston Scientific DBS patient. To learn more about his story, go to page 14 of this brochure.

2 Parkinson s Disease Parkinson s disease is a movement disorder affecting roughly one million Americans 1 and more than ten million people worldwide. 2 While the exact cause remains unknown, the deficiency of dopamine-producing cells in the brain is a primary factor. This shortage of dopamine, an important chemical substance in the brain used to transmit signals in the motor regions, reduces the brain s ability to control or initiate movement, resulting in the primary symptoms of Parkinson s such as resting tremor, rigidity, slow movements or bradykinesia and postural instability. 2

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4 Treating Parkinson s Disease 3 The first line of treatment for recently diagnosed patients is usually medication. While there are many types of medications used to treat the symptoms of Parkinson s disease, one of the most common first-line treatments is levodopa (L-DOPA). * L-DOPA is a chemical precursor to dopamine. When you take a dose of levodopa, your body converts it to dopamine, restoring your brain to levels it should normally have, and helping you achieve better control over your movements, known as ON time. Many early PD patients achieve good quality ON time with their levodopa regimen and report a high level of satisfaction. * Remember, for all medical decisions, always talk to your doctor about what the best course of action is for your specific needs. 4

5 Unfortunately, when the dose wears off, the symptoms of Parkinson s return. This is known as OFF time. As the disease advances, patients will need to take additional doses at more frequent intervals to achieve a moderate level of control. Higher doses of levodopa may lead to unintended side effects such as uncontrolled, dance-like movements, known as dyskinesia. These fluctuations between ON and OFF states are often a catalyst for a switch to a different medication. ON/OFF Fluctuations with Levodopa Treatment EARLY PD MODERATE PD ADVANCED PD OFF time ON time OFF time L-DOPA doses Dyskinesia 5

6 By Five Years After Diagnosis, the Average Parkinson s Patient 4 Takes medications 4 times a day Takes 9 individual pills a day * Has changed his or her medication regimen three times 6 *Inclusive of the following formulations of Parkinson s disease medications: tablet, transdermal patch, and injection.

7 The Difference that DBS Can Make I was taking 36 pills per day and talked to my neurologist about it. I was getting to the point where I got tired of taking pills and he said, DBS is ready to go any time you are, and I said, Okay, let s do it. DBS Patient Many patients with Parkinson s disease struggle with the impact their medication regimen has on their lives. Unfortunately, most don t know that there are alternatives. That s why it s important to speak with a neurologist who specializes in movement disorders, and ask if DBS could be an option for you. 7

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9 What Is Deep Brain Stimulation? Deep Brain Stimulation is a medical treatment for managing the symptoms of Parkinson s disease when medication alone is no longer effective. DBS uses a small medical device that is implanted in your body to stimulate a portion of your brain. The treatment may help to improve your motor functions that are affected by Parkinson s disease such as tremor, slowness, and rigidity. 9 9

10 How DBS Works Deep Brain Stimulation uses a modest medical device to send signals to your brain to help control the symptoms of Parkinson s disease. Your doctor will place one or two insulated wires called leads in the brain. The leads are then connected to the stimulator and the stimulator is placed under the skin in the chest. When the stimulator is turned on, it produces mild electrical impulses that stimulate a specific target within the brain. The stimulation may help regulate the incorrect signaling in the brain, improving some of the symptoms of Parkinson s disease. 10

11 DBS Has Changed the Lives of Hundreds of Thousands of Parkinson s Disease Patients 25% greater improvement in mobility in 6 months 5 56% improvement in motor symptoms after one year 6,7,8 Marked improvements in motor function sustained until at least 5 years 7 Reduction in Tremors People with tremor will typically experience an average of 70% reduction in tremor, depending on its type and location. 9 Reduction in Medication With DBS, you may be able reduce the amount of medicine you re taking, which means getting freedom from the difficult side effects, like uncontrolled movements, incontinence, and moodiness. 10 Increased Mobility With DBS, you tend to get 8 10 hours of ON time meaning you re in control, and have the independence to get around and live your life without rigidity or freezing. 6,7,8 11

12 Meet Vercise DBS Comfort, for your lifestyle Our ultra-lightweight, thin battery was designed with smooth and gently rounded edges to maximize your comfort and reduce visibility after implantation. Intelligence, with options Vercise DBS was designed with our precision technology standard, enabling your doctor to deliver therapy with precision, and the flexibility to adapt your treatment as the needs of your condition change. Patients: first, and always From start to finish, we designed Vercise DBS with you in mind. And we re with you every step of the way. 12

13 A Long Battery Life with Rechargeable Technology The Vercise System from Boston Scientific is a rechargeable system, which results in a greatly extended battery life compared to the currently available systems that cannot be recharged. In fact, Vercise was designed to have a battery longevity of up to 15 years. This reduces your need for a reimplantation surgery in the future, giving you one less thing to worry about. 13

14 A Life Transformed I feel really lively, like I m young again. I ve got my life back. I now have huge expectations for the future. I still have a lot to do. Pedro Curry Retired architect Pedro Curry loved to paint and draw, but when his Parkinson s disease progressed, he could no longer draw a straight line. Unable to walk and confined to a wheelchair, he consulted a physician who suggested he might be a candidate for DBS. After a series of preoperative tests, Pedro decided to move ahead with the surgery. He entered the hospital in a wheelchair and, following a successful procedure, was able to walk away on foot three days after his surgery. Today, Pedro is living his life again, walking, painting, and spending time with family. Individual results may vary. Not every individual will experience the same benefits. 14

15 Why Choose Boston Scientific? Different from What You ve Seen Before Our approach to DBS is different from what you ve seen before. Most companies use their existing cardiac pacemakers and repurpose them for DBS. At Boston Scientific, we know your brain is more complicated than this. That s why we considered what we thought the perfect technology for DBS would be, so we applied and adapted the exquisite sensitivity of a cochlear implant. We call this multiple independent current control (MICC). MICC has a long name, but it s really a simple idea: doctors use it to control the placement and intensity of your therapy with precision. As a Parkinson s patient, this means that as the needs of your condition change, your DBS system from Boston Scientific gives you and your doctor the fine-tuning options you need at the right time. 15

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17 A Life Restored The difference it s made to my life is just remarkable. Peter Vanderburg Peter had a very painful, uncontrolled tremor in his right arm. Things got so bad for Peter that he was spilling hot coffee and dropping kitchen utensils regularly. That s when Peter and his wife Lisa went to see a neurologist, who recommended DBS as a treatment option for him. Now that Peter is a Vercise patient, things have turned around for him, and for Lisa, too: They got their dad back and I ve got my husband back. And it s because of Boston Scientific and Vercise. Individual results may vary. Not every individual will experience the same benefits. 17

18 Frequently Asked Questions Q: Is Deep Brain Stimulation safe? A: The short- and long-term safety of DBS has been well-established. 5,6,7,8 It has been around for over two decades. More than 100, patients have been treated with DBS. You should review the risks of DBS with your physician. Q: What are the possible benefits of DBS? A: DBS may help you to control some of the disabling symptoms of your condition. You may be able to increase your daily life activities and improve your overall quality of life. Unlike ablative surgeries, DBS is a non-destructive form of surgery. It is also reversible. The stimulator and lead can be removed, or the entire system can be turned off at any time. 18

19 Q: How long will my DBS system last? A: While results will vary depending on individual settings, the Vercise DBS System carries a powerful, rechargable battery technology which was designed to last up to 15 years. Q: Can I travel with my DBS system? * A: Yes, you can travel with your DBS system. Metal detectors, X-ray machines, security scanners, and other security devices will not damage the implant but may cause unintentional stimulation. The implant may also activate metal detector alarms, so it is recommended you carry your patient ID card with you at all times. Q: What are the possible risks of DBS? * A: As with any surgical procedure and implanted medical device, there are risks involved. Please discuss these risks with your physician, and review the back cover of this brochure. *Please review the back cover of this brochure. 19

20 Q: Can I get an MRI? A: DBS patients have many diagnostic imaging options available to them. Commonly used methods such as X-rays, CT scans, PET scans and ultrasounds are all compatible with Vercise. However, the Vercise DBS System is contraindicated for MRI. Always consult with your doctor to see which imaging modality is the best option for your specific case. For more information, please review the back cover of this brochure. Q: Will my insurance cover DBS therapy? A: If you re a Medicare patient, the majority of your cost for DBS therapy will be covered. Most other health plans will also cover DBS; however, your doctor or hospital may need to provide an authorization prior to the procedure. Our Pre-Authorization Support team can help you understand what your insurance company will and will not cover. Call our team at

21 Q: Could I be a candidate for Deep Brain Stimulation? A: For Parkinson s patients, the ideal candidate continues to respond positively to levodopa treatment but is unable to control the motor symptoms of his or her disease with medication alone. DBS surgery would be carried out by a neurosurgeon working as part of an interdisciplinary team. Your neurologist and other physicians with whom you work closely can determine if DBS is a suitable therapy for you and your symptoms. Q: Where can I go to learn more? A: For more information, go to DBSandMe.com, or call our Customer Care team at 833-DBS-INFO to speak with a Boston Scientific representative about your questions today. 21

22 Patient Name Diagnosed with Parkinson s When you first wake up On Time Off Time Morning hours When Late Morning Afternoon Late Afternoon Sex Completed by Evening TYPE BRAND DOSAGE Age When you go to bed Next Steps Ready to learn more? Here are three quick things you can do today: 1. Visit DBSandMe.com, Boston Scientific s online educational community to learn more about how DBS is helping PD patients like you. 2. Use our self-assessment tool to see if DBS could be a possible treatment option for you. 3. Download a personalized discussion guide and use it to start the conversation with a neurologist about achieving better control over your Parkinson s with DBS. YOUR DBS. YOUR DISCUSSION. A discussion guide for Parkinson s patients 1. Background Information Use this guide to discuss with your movement disorder neurologist whether Deep Brain Stimulation could be a good option for you. 2. Symptoms Y/N Y/N Tremor for at least 5 years Bradykinesia for at least 5 years Rigidity for at least 5 years Dyskinesia for at least 5 years Freezing of gait for at least 5 years 3. Good Quality ON Time Each Day Indicate when during the day you have good control over your movements by circling the faces for each time of day. Reported Treatments Prescription drugs Non-drug treatments 22

23 About Boston Scientific Core Businesses Founded in 1979, Boston Scientific is a global medical device company dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Interventional Cardiology Technologies for diagnosing and treating coronary artery disease and other cardiovascular disorders. Rhythm Management Solutions for treating irregular heart rhythms and heart failure, and protecting against sudden cardiac arrest. Urology/Women s Health Solutions for treating urological and gynecological disorders like kidney and bladder stones, stress urinary incontinence, pelvic organ prolapse, and excessive uterine bleeding. Neuromodulation Microelectronic Implantable technologies for managing chronic neuropathic pain and neurological diseases. Electrophysiology Technologies, such as mapping catheters, radiofrequency energy, and cryogenics, for diagnosing and treating heart rhythm disorders. Endoscopy Technologies for diagnosing and treating diseases of the digestive system, airway and lungs. Peripheral Interventions Products that treat vascular system blockages in areas such as the carotid and renal arteries and the lower extremities. 23

24 References 1. Accessed 25SEP Accessed 25SEP Accessed 25SEP2017; treatment/con Accessed 25SEP2017; Accessed 25SEP Boston Scientific patient market research. Data on file. 5. Deuschel et al. A randomized trial of deep-brain stimulation for Parkinson s disease. N Engl J Med : Okun et al. Subthalamic deep brain stimulation with a constant current device in Parkinson s disease: An open-label, randomised, controlled trial. Lancet Neurology : Timmerman et al. Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson s disease (the VANTAGE study): a non-randomized, prospective, multi-centre, open label study. Lancet Neurology : Krack et al. Five-year follow up of bilateral stimulation of the subthalmaic nucleus in advanced Parkinson s disease. N Eng J Med : Farris, S. and Giroux, M. (2013). DBS: A Patient Guide to Deep Brain Stimulation. Movement and Neuroperformance Center. Colorado. 10. Weaver et al. Bilateral deep brain stimulation vs best medical therapy for patients with advanced Parkinson Disease: A randomized Controlled Trial. JAMA : Lozano and Lipsman. Probing and regulating dysfunctional circuits using deep brain stimulation. Neuron : Indications for Use: The Vercise Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to advanced levodopa-responsive Parkinson s disease (PD) that are not adequately controlled with medication. Contraindications: The Vercise DBS System is not recommended for patients who will be exposed to the following procedures: Diathermy as either a treatment for a medical condition or as part of a surgical procedure, Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation (TMS). The safety of these therapies in patients implanted with the Vercise DBS System has not been established. Patients implanted with the Vercise DBS System should not have Magnetic Resonance Imaging (MRI). The Vercise DBS System is not recommended for patients who are unable to operate the system or are poor surgical candidates or who experience unsuccessful test stimulation. Warnings: Unauthorized modification to the medical devices is prohibited. You should not be exposed to high stimulation levels. High level of stimulation may damage brain tissue. Patients implanted with the Vercise DBS System may be at risk for intracranial hemorrhages (bleeding in the brain) during DBS lead placement. Strong electromagnetic fields, such as power generators, security screeners or theft detections systems, can potentially turn the stimulator off, or cause unpredictable changes in stimulation. The system should not be charged while sleeping. If you notice changes in mood or behavior or have thoughts of suicide contact your physician immediately. Chemical burns may result if the Vercise Stimulator housing is ruptured or pierced. The Deep Brain Stimulation System may interfere with the operation of implanted stimulation devices, such as cardiac pacemakers, implanted cardioverter defibrillators, or medication delivery pumps. Patients should operate motorized vehicles or potentially dangerous machinery with caution. It is unknown if the device may hurt an unborn baby. Your doctor may be able to provide additional information on the Boston Scientific Vercise DBS System. For complete indications for use, contraindications, warnings, precautions, and side effects, call 833-DBS-INFO or All trademarks are the property of their respective owners. Illustrations for information purposes not indicative of actual size or clinical outcome. CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician Rye Canyon Loop Valencia, CA USA DBSandMe.com Copyright 2017 by Boston Scientific Corporation or its affiliates. All rights reserved. NM AA_OCT2017