Advanced Therapy for Chronic Pain Relief: Neurostimulation

1. Advanced Therapy for Chronic Pain Relief: Neurostimulation

2. Discussion • What brings you here today? • What is neurostimulation? • How can you know that it will help your pain? • What are the next steps?

3. What Has Been Your Success with These Therapies? • TENS • NSAIDs • Ibuprofen and Aspirin • Pain Medications • Biofeedback • OTC Pain • Rehabilitative Therapy • Systemic Opioids • Morphine • Nerve Blocks

4. How Would You Like Your Life to Improve? • What activities do you want to be able to do ? • How would you like your life to change?

5. "Without this therapy, I would be in a wheelchair. Instead, I'm fishing with my family.”-Luella Thomas*, patient and ANS Ambassador *The above testimonial is the experience of this individual only. It is an individual result and we do not claim that it is representative of the experience that all or most patients achieve and is not indicative of future performance or success.

6. Your Physician Has Recommended Neurostimulation Most likely because • You have had pain that has lasted more than 4-6 months • You have had limited pain relief from your current pain medications or pain therapies • You have had multiple procedures that have not worked

7. What Is Neurostimulation? • Neurostimulation is also commonly known as spinal cord stimulation (SCS) • A non-drug pain relief therapy that works by generating mild electrical pulses and sending them along your spinal cord to the brain • It replaces the feeling of pain with a tingling or massaging sensation

8. Established Therapy for Chronic Pain • Neurostimulation is a widely accepted medical treatment. • Similar technology to pacemakers. • Each year as many as 50,000 neurostimulators are implanted worldwide.1 1Simpson BA. Electrical Stimulation and the Relief of Pain. Boston, Mass: Elsevier; 2003. Pain Research and Clinical Management, Vol. 15.

9. Established Therapy for Chronic Pain • FDA-approved therapy for treatment of chronic pain of the trunk and limbs • Covered by most major health insurance plans, Medicare and worker’s compensation programs

10. A Study of Chronic Pain Sufferers Who Used ANS Neurostimulators¹ • 84% reported that their quality of life was improved or greatly improved • 77% had good or excellent pain relief • 82% decreased their use of pain medications ¹Advanced Neuromodulation Systems. Prospective, Multi-Centered, Single Arm Study to Evaluate the Safety and Effectiveness of Genesis™ Implantable Pulse Generator in Combination with ANS Percutaneous Leads for the Management of Chronic Pain of the Trunk and/or Limbs. Plano, Tex; 2006.

11. “I felt my little toes for the first time in years, and I started crying. It was the most wonderful sensation I’d ever felt.” -Deborah Sanders*, patient since 2006 and ANS Ambassador *The above testimonial is the experience of this individual only. It is an individual result and we do not claim that it is representative of the experience that all or most patients achieve and is not indicative of future performance or success.

12. How will I Know if This Therapy will Reduce My Pain? • A “trial period” allows the patient to evaluate the effect of pain relief before deciding on this therapy in the long term

13. The Trial (Screening) Period • Has a unique advantage over other pain management therapies in that it can be removed at any time • Typically 5-7 days

14. What Can I Expect During a Trial? • A minimally invasive outpatient procedure • Similar to an epidural steroid injection • One or more leads are placed in the space along the spinal cord

15. What Can I Expect During a Trial? • Patient is generally awake during the procedure so that they can provide feedback to the physician regarding exact placement.

16. What Can I Expect During a Trial? • The lead or leads connect to a system that can be worn on a belt. The system may contain a variety of programs to allow the patient to best evaluate the stimulation.

17. What Are The Elements of a Successful Trial? • Your pain is reduced to a manageable level so that you may return to a more normal lifestyle • Many people consider spinal cord stimulation successful if: • It is easier for them to go places and do things • It helps them sleep better • It reduces their need for drugs

18. If the Trial is Successful, What Happens Next ? • You may wish to discuss delivery of this therapy with your physician • Discuss what type of system is best for your pain needs and lifestyle • Implanted device may be performed as an outpatient procedure • Although called permanent, still reversible

19. Patient Ambassador Program • Opportunity to connect with real patients who have ANS devices • Candidate can email or phone • Patient ambassadors are volunteers

20. “In a heartbeat. I highly recommend it.” “It’s something everybody can understand. It’s easier to use than a remote control on a TV.”-Ralph Wright*, patient and ANS Ambassador *The above testimonial is the experience of this individual only. It is an individual result and we do not claim that it is representative of the experience that all or most patients achieve and is not indicative of future performance or success.

21. More Information • Talk to your ANS clinical representative • Go to PowerOverYourPain.com for more information • Contact a Patient Ambassador • Check your insurance coverage

22. Eon® and Genesis® SystemsIndicated Use Statement • “Aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with any of the following: failed back surgery syndrome, and intractable low back and leg pain.”

23. Renew® RF SystemIndicated Use Statement “Indicated for spinal cord stimulation in the treatment of chronic pain of the trunk and limbs either as a sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach .”

24. Product Safety Information • Indications for Use: Chronic, intractable pain of the trunk and limbs. • Contraindications: Demand-type cardiac pacemakers, patients who are unable to operate the system or who fail to receive effective pain relief during trial stimulation. • Warnings/Precautions: Diathermy therapy, cardioverter defibrillators, magnetic resonance imaging (MRI), explosive or flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery and equipment, postural changes, pediatric use, pregnancy, and case damage. Patients who are poor surgical risks, with multiple illnesses, or with active general infections should not be implanted. • Adverse Events: Painful stimulation, loss of pain relief, surgical risks (e.g., paralysis). • User’s guide must be reviewed prior to use for detailed disclosure. • Caution: U.S. federal law restricts this device to sale and use by or on the order of a physician.

25. Questions?

26. Additional Information Regarding Neurostimulation

27. Trial Lead Trial Cable Trial Transmitter Components of a Trial System

28. What is My Role During a Trial Screening? • Understand and comply with movement restrictions • Understand what sensations to expect

29. What Is My Role During a Trial Screening? • Document your response to treatment, pain level and functional changes (trial diary will be provided) • Follow physician’s recommendations on activity level

30. During the Trial: Do’s • Follow you physician’s orders regarding activities and wound care • Sleep on your back or side • Keep your incision dry by taking sponge baths • Keep a trial diary • Call your physician immediately if you notice any signs of infection such as • Fever • Chills • Redness • Increased pain at the incision site

31. During the Trial: Don’ts • Pull on the trial cable or lead • Disconnect the trial cable from the lead • Operate vehicles, machinery, or power equipment with the stimulator on • Reach, bend, or stretch • Lift more than five (5) pounds • Climb many stairs • Sleep on your stomach • Engage in strenuous activity during the trial

32. Implanted device • Generator and leads placed within body • Procedure time may be similar to a trial procedure • Often performed on an outpatient basis or in a surgery center • Reversible

33. What are the Components of a Neurostimulator? • Programmer • "Remote control” that lets you adjust the strength and/or location of stimulation • Generator • Holds the electronic components and sends the electrical current through the lead • Leads • Very thin cables that deliver electrical pulses to nerves along your spinal cord

34. Eon® and Genesis® SystemsIndicated Use Statement • “Aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with any of the following: failed back surgery syndrome, and intractable low back and leg pain.”

35. Renew® RF SystemIndicated Use Statement “Indicated for spinal cord stimulation in the treatment of chronic pain of the trunk and limbs either as a sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach .”

36. Product Safety Information • Indications for Use: Chronic, intractable pain of the trunk and limbs. • Contraindications: Demand-type cardiac pacemakers, patients who are unable to operate the system or who fail to receive effective pain relief during trial stimulation. • Warnings/Precautions: Diathermy therapy, cardioverter defibrillators, magnetic resonance imaging (MRI), explosive or flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery and equipment, postural changes, pediatric use, pregnancy, and case damage. Patients who are poor surgical risks, with multiple illnesses, or with active general infections should not be implanted. • Adverse Events: Painful stimulation, loss of pain relief, surgical risks (e.g., paralysis). • User’s guide must be reviewed prior to use for detailed disclosure. • Caution: U.S. federal law restricts this device to sale and use by or on the order of a physician.

37. Thank you for your time!