DRG STIMULATION INTERVENTIONAL PAIN CENTER

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1 DRG STIMULATION Shawn M. Sills, MD at Touchstone Interventional Pain Center has been selected by St Jude Medical to be first in Southern Oregon delivering this new FDA approved therapy to patients. You can discuss this therapy with your primary care doctor to learn if it may be the best treatment option for you. The Dorsal Root Ganglion (DRG) is at the posterior root of each spinal nerve. Pain signals travel from the lower limbs to the brain, on the way they pass through the dorsal root ganglion. DRG stimulation targets the specific regions of the cord that are transmitting the pain and shuts down those painful signals directly by placing the leads DIRECTLY OVER THE DRG s. The FDA clinical trial (ACCURATE Study) showed that electrically stimulating the ganglion offers patients better and more targeted pain relief from Complex Regional Pain Syndrome (CRPS). INTERVENTIONAL PAIN CENTER 2925 Siskiyou Boulevard Medford, OR

2 Images courtesy of St. Jude Medical, Inc Complex Regional Pain Syndrome CRPS is a chronic pain condition that affects a part of the body following an injury or trauma. CRPS is felt to be caused in part by damaged or malfunctioning nerves. CRPS affects the way the central nervous system and the peripheral nervous system send pain signals from the brain and spinal cord to the rest of the body. Often characterized by prolonged or excessive pain, CRPS can cause mild or dramatic changes in skin color, temperature, and/or swelling in the affected area. The Axium DRG Neurostimulator System is part of our dorsal root ganglion therapy portfolio. Our vision is to transform the management of chronic pain by expanding the range of neurostimulation options available and setting a new standard with the lasted technology and therapies to help improve the lives of more chronic pain patients. The ACCURATE STUDY: St Jude Medical: news-releases-details/2015/long-term-data- Confirms-the-St-Jude-Medical-Axium-System-Delivers- Sustained-and-Superior-Pain-Relief-for-Patients-with- Chronic-Lower-Limb-Pain INTERVENTIONAL PAIN CENTER

3 PAIN INTER- RUPTED DRG THERAPY FOR CHRONIC PAIN LIFE TRANSFORMED

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5 A DIFFERENT TYPE OF PAIN CALLS FOR A D I F F E R E N T APPROACH. Chronic pain* is a common condition, affecting almost one in five adults globally. 1 But yours is different from most. You ve tried the methods that work for other people, but nothing seems to help. It s well known that this kind of pain is limited to a specific area of your body. This sort of difficult-to-treat isolated chronic pain may start in a lower extremity (foot, knee, hip, and groin) following an injury or surgical procedure and grow worse over time. Now imagine your life transformed. Because today, there s a unique approach to pain like yours: neurostimulation that stimulates the dorsal root ganglion a cluster of nerve cells in the spine, also called the DRG that directly targets the area of the body where your pain occurs. This is a new therapy using a well-studied and understood approach for addressing the type of pain you re suffering. DRG therapy is the next generation in pain relief and it s offered exclusively by St. Jude Medical. *Chronic pain defined as pain that has been present for a minimum of six months. 2 1

6 PAIN SIGNALS TRAVEL TO THE DRG: Foot Knee Groin Hip

7 HERE S HOW DRG THERAPY CAN HELP. The Dorsal Root Ganglion (DRG) has been of interest to pain physicians for years. This nerve cluster acts like a traffic light, regulating signals and sensations as they travel to the brain. Stimulation of the DRG can actually modify the pain signals getting through resulting in the reduction of pain. For patients with pain that is limited to a specific area of the body, DRG therapy often works where other treatments may not or provide only partial relief. That s because the DRG corresponds to specific anatomical locations in the body and relays information, such as pain signals, to the brain. Because of its unique ability to target the areas of the body where pain occurs, DRG therapy can be especially helpful for patients like you. 3

8 MORE THAN 300,000 PEOPLE HAVE SUCCESSFULLY RECEIVED NEUROSTIMULATION SYSTEMS OVER THE PAST 40 YEARS. 4

9 THE DRG SYSTEM. IT S THIS SIMPLE. THE DRG NEUROSTIMULATOR SYSTEM CONSISTS OF THREE COMPONENTS: THE GENERATOR - a small device that sends out mild electrical pulses, which contains a battery. This is implanted in your body. THE LEADS - thin insulated wires that carry the electrical pulses from the generator to your dorsal root ganglia. These are placed in your body in the area of the DRG. THE PATIENT CONTROLLER - a handheld remote control that allows you to adjust the strength and location of stimulation or even turn stimulation off. Placement of the DRG system is similar to that of other neurostimulation devices. 5

10 MAKE SURE DRG THERAPY WORKS FOR YOU. TRY IT OUT FIRST. One of the benefits of the DRG neurostimulation system is that you can be fitted with a temporary device that works like an implanted system but can be removed. This allows you to determine its effectiveness for your pain prior to undergoing an implant. You will have a short, minimally-invasive procedure, during which you are awake and answering questions. Your doctor will: Implant a few small, thin leads near your DRG. Attach the leads to a temporary generator that you can wear outside of your clothing or on your belt. Ask you to provide feedback on where you feel stimulation. Afterward, you will be trained to use the device and find the settings that feel best. While you wear the temporary system you will be asked to limit physical activities that involve lifting, bending, twisting or raising your arms above your head. Otherwise, you will be able to resume daily living. Look forward to the ability to do and enjoy things, like sleeping, walking and shopping, that were once difficult. Life more like you remember it before the pain.

11 Look forward to the ability to do and enjoy things, like sleeping, walking and shopping, that were once difficult. Life more like you remember it before the pain. 7

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13 DRG THERAPY WORKS! NOW WHAT? Now, it s time to talk to your doctor about having the system implanted. You will need to stop the temporary stimulation briefly before the surgery to implant the generator. You ll likely be admitted to a surgery center and some of the components of the temporary system may be removed. The implant does involve a minimallyinvasive surgical procedure that includes implanting the generator under your skin. It s important that you discuss with your doctor all of the complications associated with an implanted neurostimulation device and whether you are at risk. The generator will be implanted with leads that will be placed close to the target dorsal root ganglia identified during the temporary evaluation. As with the evaluation procedure, you will be awake and answering questions. Within a few days, your system should begin working just like before. Generator and Patient Controller 9

14 WHAT ARE THE RISKS ASSOCIATED WITH THIS PROCEDURE? The placement of a neurostimulation system requires surgery, which exposes patients to certain risks. Complications such as infection, swelling and bruising are possible. Additional risks such as undesirable changes in stimulation may occur over time. Be sure to talk to your doctor about all the possible risks associated with neurostimulation. WHAT ARE SOME OF THE RESTRICTIONS I MAY HAVE WITH AN IMPLANTED SYSTEM? Your doctor will give you detailed information about restrictions and activities with your system. As a general rule, however, it is important to restrict the amount of bending, twisting and reaching you do for the first six to eight weeks after surgery. This is the time that the healing is taking place around the leads. There are also some permanent restrictions associated with receiving a neurostimulation system. Be sure to ask your doctor for a complete list of restrictions.

15 PROOF OF EFFECTIVE RELIEF FOR PATIENTS LIKE YOU. THE LARGEST NEUROSTIMULATION CLINICAL TRIAL EVER CONDUCTED AMONG PATIENTS with chronic intractable lower limb pain typically resulting from a previous injury, the ACCURATE clinical study, showed that with DRG therapy: patients enrolled in study % of DRG patients had pain relief at 12 months* % of patients % 74.2 % Control DRG *Compared with the Control group % of DRG patients did not experience stimulation outside of their primary area of pain at 12 months.* DRG patients had an average of 81.4 % REDUCTION in their pain at 12 months. 11

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17 LIVE A LIFE TRANSFORMED. There is no cure for most conditions that cause difficult-to-treat isolated chronic pain. But DRG therapy can interrupt that pain allowing you to enjoy the simple things in life again. Sleep well, work at the job you love, take a walk after dinner. Without the pain, you can live a life transformed. 13

18 CONTACT YOUR DOCTOR FOR MORE INFORMATION. To learn more about DRG therapy, please speak with your physician and visit 1. Breivik, H., Hattori, S., & Moulin, D.E. (2005). Prevalence and impact of chronic pain: A systematic review of epidemiological studies on chronic pain. Presented at the International Association for the Study of Pain (IASP) 11th World Congress on Pain, Sydney, Australia. 2. American Chronic Pain Association. APCA Consumer Guide to Pain Medication and Treatment. theacpa.org/uploads/acpa_resource_guide_2012_update% pdf. Accessed March 11, Levy, R. & Deer, T. (2015). A prospective, randomized, multi-center controlled clinical trial to assess the safety and efficacy of the Spinal Modulation Axium Neurostimulator System in the treatment of chronic pain. Presented at NANS The American Association of Neurological Surgeons. Spinal Cord Stimulation. Information/Conditions and Treatments/Spinal Cord Stimulation.aspx. Accessed March 21, 2016 Indications for Use: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.** *Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. **Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively. Contraindications: Patients contraindicated for the Axium Neurostimulator System are those who are unable to operate the system and are poor surgical risks. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to proceed to the INS procedure. Potential Adverse Events: The implantation of a neurostimulation system involves risk. Implant Manual must be reviewed for detailed disclosure. Refer to the User s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events. CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE ORDER OF A PHYSICIAN. Rx Only Brief Summary: Prior to using these devices, please review the User s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Unless otherwise noted, indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies St. Jude Medical, Inc. All Rights Reserved. St. Jude Medical Inc. Global Headquarters One St. Jude Medical Drive St. Paul, MN USA T F St. Jude Medical S.C., Inc. Americas Division 6300 Bee Cave Road Bldg. Two, Suite 100 Austin, TX USA T F SJM Coordination Center BVBA The Corporate Village Da Vincilaan 11-Box F1 B-1935 Zaventem, Belgium T F sjm.com/pain SJM-AXM Item approved for U.S. use only.

19 ACCURATE CLINICAL STUDY DRG THERAPY FOR CHRONIC PAIN FACT SHEET FOR PATIENTS

20 It was the kind of pain where you couldn t push through it now I am back to living life again and not having any pain. Jenifer, a DRG therapy recipient

21 WHAT IS DRG THERAPY? DRG therapy works much like traditional neurostimulation. Neurostimulation is a therapy that influences the signals sent to the brain through the use of an implanted stimulation device. The therapy uses mild electrical signals to intercept pain signals before they reach the brain. What s different about DRG therapy, as demonstrated in the ACCURATE clinical study, is that it uses electrical pulses to stimulate a cluster of nerve cells in the spinal column called the dorsal root ganglion(s) that directly corresponds to the area of the body where the pain occurs. PAIN SIGNALS TRAVEL TO THE DRG: Foot Knee Groin Hip

22 WHAT IS THE ACCURATE STUDY? The ACCURATE clinical study is the largest randomized, controlled neurostimulation trial conducted in patients with complex regional pain syndrome (CRPS) and peripheral causalgia, to assess the safety and efficacy of dorsal root ganglion or DRG stimulation in the treatment of chronic, intractable pain (defined as difficult-to-treat pain that has been present for a minimum of six months 1 ). 152 patients enrolled in study There were 152 subjects with chronic, intractable pain of the lower limbs enrolled and randomized in the ACCURATE clinical study. They were randomized to a DRG stimulation group or a control group (using a traditional neurostimulation device) across 22 investigational sites.

23 The ACCURATE clinical study was designed to measure whether a new type of neurostimulation, called DRG therapy, can help more patients with difficult-to-treat isolated pain caused by CRPS of the lower limbs. This kind of pain may be focused in a lower extremity (foot, knee, hip or groin); it is believed to be a problem in the nervous system affecting the way pain signals are sent between the brain and the rest of the body. But for patients with CRPS, traditional pain management methods including traditional neurostimulation often don t work. All 152 patients enrolled and randomized in the ACCURATE clinical study experienced chronic pain in a lower extremity. The pain typically began after an injury, surgery, or other medical intervention and continued for six or more months. Some patients also had one or more other symptoms, including extreme sensitivity to touch or joint movement, changes in skin temperature and/or color, swelling, changes in sweating, decreased range of motion or weakness in motor control. These symptoms are often associated with CRPS, which has previously been known as reflex sympathetic dystrophy (RSD).

24 WHAT WAS THE GOAL OF THE ACCURATE CLINICAL STUDY? The goal of the ACCURATE clinical study was to demonstrate safety and efficacy of DRG stimulation as compared to traditional neurostimulation. WHAT WERE THE RESULTS OF THE ACCURATE STUDY? 2 86 % of DRG patients had persistent pain relief at 12 months* 100 % of patients % 86 % Control DRG *Based on Implant Only (IO) population.

25 DRG patients had an average of 81.4 % REDUCTION in their pain at 12 months % of DRG patients did not experience stimulation outside of the area of pain at 12 months. DRG therapy requires surgery, which exposes patients to certain risks. Complications such as infection, swelling, bruising and possibly the loss of strength or use in an affected limb or muscle group (e.g. paralysis) are possible. Additional risks such as undesirable changes in stimulation may occur over time. If you are interested in learning more about DRG therapy and pain management, please talk to your doctor. DISCOVER MORE and find a DRG specialist near you at SJM.com/Pain

26 1. American Chronic Pain Association. APCA Consumer Guide to Pain Medication and Treatment. Update% pdf. Accessed March 11, ACCURATE Trial Clinical Report for Protocol 03-SMI-2012 dated January 19, Rx Only Brief Summary: Prior to using these devices, please review the User s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Indications for Use: US: Spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.** *Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. **Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively. CE Mark: The Spinal Modulation Neurostimulator System is indicated for the management of chronic intractable pain. Australia: The Spinal Modulation implantable neurostimulation system is indicated for spinal cord stimulation (SCS) for the management of chronic, intractable pain of the trunk and/or limbs. Contraindications: US: Patients who are unable to operate the system, who are poor surgical risks, or who have failed to receive effective pain relief during trial stimulation. CE MARK and Australia: Patients who have an active implantable medical device including but not limited to cardiac pacemakers and cardiac defibrillators, are unable to operate the system, and are poor surgical risks. Warnings/Precautions: Diathermy therapy, implanted cardiac systems or other active implantable devices, magnetic resonance imaging (MRI), computed tomography (CT), electrosurgery devices, ultrasonic scanning equipment, therapeutic radiation, explosive or flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery and equipment, pediatric use, pregnancy, and case damage. Adverse Effects: Painful stimulation, loss of pain relief, surgical risks (e.g., paralysis). Implant Manual must be reviewed for detailed disclosure. Refer to the User s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events. Implant Manual must be reviewed for detailed disclosure. Refer to the User s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events. CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE ORDER OF A PHYSICIAN. Unless otherwise noted, indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, LLC and its related companies St. Jude Medical, LLC. All Rights Reserved. St. Jude Medical Inc. Global Headquarters One St. Jude Medical Drive St. Paul, MN USA T F St. Jude Medical S.C., Inc. Americas Division 6300 Bee Cave Road Bldg. Two, Suite 100 Austin, TX USA T F SJM Coordination Center BVBA The Corporate Village Da Vincilaan 11-Box F1 B-1935 Zaventem, Belgium T F SJM.com/Pain SJM-AXM h Item approved for global use.

27 A NEW CHRONIC PAIN THERAPY OFFERED EXCLUSIVELY BY ST. JUDE MEDICAL MAY BE RIGHT FOR YOU. Dorsal root ganglion (DRG) therapy, a new form of neurostimulation, is clinically-proven to relieve difficult-to-treat chronic pain of the lower limbs. DRG therapy may be able to provide you relief if you have chronic pain associated with complex regional pain syndrome (CRPS) in any of the following areas: IMAGINE FINALLY Foot pain Ankle pain Knee pain Groin pain Hip pain Hernia pain FINDING RELIEF While neurostimulation helps most patients receive at least some reduction in pain, not everyone responds in the same way. Complications include: painful stimulation, loss of pain relief and certain surgical risks (e.g., paralysis). Be sure to discuss the risks and benefits of neurostimulation with your doctor. TALK TO YOUR DOCTOR to learn if DRG therapy can help you finally find relief. Learn more at SJM.com/Pain Rx Only Brief Summary: Prior to using these devices, please review the User s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Indications for Use: Spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.** *Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. **Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively. Contraindications: Patients who are unable to operate the system, who are poor surgical risks, or who have failed to receive effective pain relief during trial stimulation. Warnings/Precautions: Diathermy therapy, implanted cardiac systems or other active implantable devices, magnetic resonance imaging (MRI), computed tomography (CT), electrosurgery devices, ultrasonic scanning equipment, therapeutic radiation, explosive or flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery and equipment, pediatric use, pregnancy, and case damage. Adverse Effects: Painful stimulation, loss of pain relief, surgical risks (e.g., paralysis). Implant Manual must be reviewed for detailed disclosure. Refer to the User s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events. CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE ORDER OF A PHYSICIAN. Unless otherwise noted, indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies St. Jude Medical, Inc. All Rights Reserved. SJM-AXM Item approved for U.S. use only.