1. Help Patients Take Control of Chronic Pain

2. [Insert Practice Name and Location] [List Staff Members]
[Insert Speaker Name]
[Insert Practice Name and Location]
[List Staff Members]
[Insert Hospital/Practice Photo]

3. Practice Overview [Insert Mission Statement]
Example: We aim to improve quality of life and functionality through a collaborative, multidisciplinary pain management program
[Insert Practice Structure Information]
Example: Clinic, Multidisciplinary Practice, etc.
[Insert Comprehensive Practice Treatment Examples]
Examples: Interventional Procedures, Medication Management, Physical Therapy, Referral to Specialists (chiropractor, surgeon, psychiatrist, rheumatologist)
Talk briefly about the practice.
Mission
Structure
Treatment examples
Referrals required for patients to be seen there?
Importance of the referring healthcare provider
Education
Building relationships to optimize patient care

4. Topics Chronic Pain and Its Impact Chronic Pain Patient Evaluation
Medtronic Pain Therapies
Why Medtronic?
Patient Selection for Medtronic Pain Therapies
Additional Resources
The topics covered today include …

5. Chronic Pain and Its Impact
Chronic pain affects
100 MILLION
American adults*
Annually costs nation up to
$635 BILLION
in medical treatment and lost productivity*
How many chronic pain patients did you see last week?
Chronic pain impacts your patients AND your practice.
Chronic pain affects 100 million American adults and annually costs the nation up to $635 billion in medical treatment and lost productivity.* Treatment of chronic low back pain alone represents an approximate $25 billion annual cost in the United States.1
Opioid prescriptions continue to skyrocket with no corresponding improvements in the treatment of pain.2
Chronic pain can be associated with depression, affect physical function, and impair quality of life for your patients.3-6
*Institute of Medicine of the National Academies website. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Prevention-Care-Education-Research.aspx. Accessed September 5, 2013.
Barolat G, Sharan A. Ong J. Spinal cord stimulation for back pain. In: Simpson BA (ed). Electrical Stimulation and the Relief of Pain Research and Clinical Management Vol 15. Burlington, Mass: Elsevier Science:
Johns Hopkins Bloomberg School of Public Health. News Release, September 16, As opioid use soars, no evidence of improved treatment of pain. Accessed September 20, 2013.
Bair MJ, Robinson RL, Katon W, Kroenke K. Depression and pain comorbidity: a literature review. Arch Intern Med. 2003;163(20):
Turner JA, Franklin G, Heagerty PJ, et al. The association between pain and disability. Pain. 2004;112(3):307–314.
Cummins J, Lurie JD, Tosteson TD, et al. Descriptive epidemiology and prior healthcare utilization of patients in the spine patient outcomes research trial’s (SPORT) three observational cohorts. Spine. 2006;31(7):806–814.
Stewart WF, Ricci JA, Chee E, Morganstein D, Lipton R. Lost productive time and cost due to common pain conditions in the U.S. workforce. JAMA. 2003;290(18):
*Institute of Medicine of the National Academies website. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Prevention-Care-Education-Research.aspx. Accessed January 30, 2014.

6. What Is Chronic Pain?
Persistent pain that adversely affects well-being, level of function, and quality of life
May be caused by injury, infection, or ongoing condition
Stress, environmental, and affective factors may contribute
Continues when treatment stops
Types
Neuropathic: Results from damage or inflammation to nerves or nerve fibers
Nociceptive Pain: Typically arises from somatic and/or visceral structures
Some Examples
Failed Back Syndrome, Spinal Stenosis, Radicular Pain Syndrome, Complex Regional Pain Syndrome, Cancer Pain, Compression Fractures from Osteoporosis
Historical definitions often included arbitrary time elements (e.g., 3 to 6 months) and ignored significant considerations such as:
acute pain caused by an underlying condition does not automatically become chronic pain after 90 days.
a degenerative condition may cause pain that will not allow the body to reach homeostasis.
some conditions such as Complex Regional Pain Syndrome may be managed or resolved with early diagnosis and treatment.
Recent definitions include concepts you see on the slide. In distinguishing acute from chronic pain, the inability of the body to restore physiological functions to normal homeostatic levels is more important than pain duration.
Neuropathic:
Often triggered by injury, usually poorly localized burning and/or stabbing pain
Examples: postherpetic neuralgia, complex regional pain syndrome, entrapment neuropathy, peripheral neuropathy, and some cancer pain
Nociceptive:
Usually aching or throbbing in quality and well-localized
Examples: bone fractures, burns, bruises, inflammation, obstructions, or myofascial pain
Loeser JD, Melzack R. Pain: an overview. Lancet. 1999;353(9164):

7. Chronic Pain Patient Evaluation
Typical questions
Is pain acute or chronic?
Is it axial, peripheral?
Is there a radicular component?
What functional limitations are present?
Are there other associated symptoms (e.g., weakness, spasticity, bowel/bladder)?
Has patient responded to conventional treatments?
Has patient experienced complications or side effects from conventional treatments?
Typical questions we consider when evaluating a chronic pain patient include …

8. Chronic Pain Patient Evaluation
History
Pain duration, onset, location, character
Associated symptoms (e.g. weakness, shortness of breath, vision changes, gait problems)
Previous therapies (e.g. PT/OT, injections, surgery, chiropractic care, biofeedback)
Other medical and family history (e.g. clotting disorders, substance abuse)
Physical Exam
Rule out urgent processes
Identify potential pain sources
Determine if there is psychiatric or emotional involved
The patient’s history is important, also.
And, of course then we conduct the physical exam.

9. Chronic Pain Patient Evaluation
Discussion of options
Patient preferences and goals
Functional role at home or in workplace
Medical co-morbidities
Family and work history
Economics
Indicated therapies
Multidisciplinary effort
Collaborative approach to patient care begins with you
Highlight information from the slide.

10. Medtronic Pain Therapies
These therapies may be:
Effective alternatives when conventional therapies and systemic pain medications provide inadequate pain relief or intolerable side effects
Reasonable alternatives to consider before performing irreversible, neurodestructive surgical procedures1
Cost-effective interventions2-4 generally covered and paid for by payers nationwide5-6
The next slides take a closer look at Medtronic Pain Therapy options and talk more about the specialist’s treatment plans.
We’re all familiar with common treatment options, which may include NSAIDS, over-the- counter drugs, complementary medicine, long-term oral opioids, etc., and we know that multiple or simultaneous treatments are possible. Medtronic Pain Therapies may help provide patients with effective alternatives when conventional therapies and systemic pain medications provide inadequate pain relief or intolerable side effects.
Medtronic Pain Therapies also can be reasonable alternatives to consider before performing irreversible, neurodestructive surgical procedures.
In addition, they may provide patients with cost effective interventions—generally covered and paid for by payers nationwide.
Prager J, Jacobs M. Evaluation of patients for implantable pain modalities: medical and behavioral assessment. Clin J Pain. 2001;17(3):
Guillemette S, Witzke S, Leier J, Hinnenthal J, Prager JP. Medical cost impact of intrathecal drug delivery for noncancer pain. Pain Med. 2013;14(4):
Taylor RS, Ryan J, O’Donnell R, Eldabe S, Kumar K, North RB. The cost-effectiveness of spinal cord stimulation in the treatment of failed back surgery syndrome. Clin J Pain. 2010;26(6):
Kemler MA, Raphael JH, Bentley A, Taylor RS. The cost-effectiveness of spinal cord stimulation for complex regional pain syndrome. Value Health. 2010;13(6):
Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Electrical Nerve Stimulators (160.7). &SearchType=Advanced&bc=IAAAABAAAAAA&. Accessed January 3, 2014.
Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Infusion Pumps (280.14). details/ncd-details.aspx?NCDId=223&ncdver=2&bc=AgAAQAAAAAAAAA%3d% 3d&. Accessed January 3, 2014.
Prager J, Jacobs M. Evaluation of patients for implantable pain modalities: medical and behavioral assessment. Clin J Pain. 2001;17(3):
Guillemette S, Witzke S, Leier J, Hinnenthal J, Prager JP. Medical cost impact of intrathecal drug delivery for noncancer pain. Pain Med. 2013;14(4):
Taylor RS, Ryan J, O’Donnell R, Eldabe S, Kumar K, North RB. The cost-effectiveness of spinal cord stimulation in the treatment of failed back surgery syndrome. Clin J Pain. 2010;26(6):
Kemler MA, Raphael JH, Bentley A, Taylor RS. The cost-effectiveness of spinal cord stimulation for complex regional pain syndrome. Value Health. 2010;13(6):
Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Electrical Nerve Stimulators (160.7). &SearchType=Advanced&bc=IAAAABAAAAAA&. Accessed January 3, 2014.
Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Infusion Pumps (280.14). details/ncd-details.aspx?NCDId=223&ncdver=2&bc=AgAAQAAAAAAAAA%3d% 3d&. Accessed January 3, 2014.
* Please refer to the Neurostimulation Systems for Pain Therapy Brief Summary and the SynchroMed® II Drug Infusion System Brief Summary at the end of this presentation for important risk and safety information.

11. Medtronic Pain Therapies Target Site of Action
When considering Medtronic Pain Therapies, it’s important to note the difference between systemic delivery vs. targeted therapy.
In systemic delivery, oral and transdermal medications must be absorbed systemically and cross the “blood-brain barrier” to reach pain signals.
With Medtronic Pain Therapies, the treatment is targeted to the site of action.
Let’s discuss further what Medtronic pain therapies involve, including trial, implant, and features of the devices.
Please refer to the Neurostimulation Systems for Pain Therapy Brief Summary and the SynchroMed® II Drug Infusion System Brief Summary at the end of this presentation for important risk and safety information.

12. What is Spinal Cord Stimulation?
Treatment targeted to the site of action
An implantable spinal cord stimulator delivers small electrical signals through a lead implanted in the epidural space
Patients feel a tingling sensation from the neurostimulation—instead of pain— in areas where the pain was felt
In contrast, oral and transdermal pain medications must be absorbed systemically and cross “blood-brain barrier” to reach pain signals

13. Spinal Cord Stimulation
Trial
Patients can trial the therapy
Temporary system
Only component implanted is lead
Patient uses system 3-10 days
Successful trial can be followed by implant
Implantation of neurostimulator, lead(s), and extensions(s) if trial effective
A spinal cord stimulation system implant is typically completed in 2 stages – trial and implant.
Trial Purpose
Assess efficacy of neurostimulation for pain management.
Allow the physician to assess pain relief and functional improvement.
Sufficient pain relief
Increased functioning
Decreased use of systemic analgesics
Allow the physician to select a neurostimulator based on
optimal stimulation parameter settings.
energy requirements/battery longevity.
Evaluation Trial Results
Measurement tools
Trial log (entries should show pain level scores that are consistently lower than pretrial scores)
Data gathered by screening system (parameters settings used)
Monitor medications
Assess results against pre-trial goals established.
Trial outcome is positive when goals are met.
General Implant
Product verified
Patient positioned and prepped
Lead(s) implanted
Neurostimulator pocket created
Lead or extension tunneled subcutaneously
Lead or extension connected to neurostimulator
Neurostimulator implanted

14. Spinal Cord Stimulation
Medtronic AdaptiveStim® delivers better pain relief
88.7%‡ of patients reported better pain relief vs. conventional stimulation1,2
Automatically adapts to patient’s changing postural therapy needs
Maintains optimal therapy around the clock
Distinguishing characteristic of Medtronic spinal cord stimulation—AdaptiveStim
As effective as neurostimulation systems are in helping manage pain, many patients experience uncomfortable stimulation when changing positions.
To sustain comfort during these changes, patients frequently need to manually adjust stimulation when they change positions.
Until recently this problem has not been addressed by currently available technology.
Medtronic solved the problem of positional stimulation with AdaptiveStim® exclusively available with RestoreSensor.®
It is the first and only neurostimulator to automatically adapt stimulation amplitude body position.
It gives patients the opportunity for automatic adjustment of stimulation to fit their varying activities.
AdaptiveStim:
listens and senses when your patient changes position.
learns from previous experience and remembers your patients’ last comfortable setting.
responds by automatically adjusting to your patients’ optimal settings in each position.
records to provide you with objective functional data.
‡ RestoreSensor® Clinical Study compared AdaptiveStim to Medtronic conventional stimulation; 88.7% is based on analysis of one of two questions that comprised the primary endpoint of improved convenience and/or better pain relief. Percentage based on respondents who completed the pain relief question.
Medtronic advanced pain therapy using neurostimulation for chronic pain. Clinical Summary, M221494A006.
Schultz D, Webster L, Kosek P, Dar U, Tan Y, Sun M. Sensor-driven position-adaptive spinal cord stimulation for chronic pain. Pain Physician. 2012;15(1):1-12.
* Please refer to the Neurostimulation Systems for Pain Therapy Brief Summary and the SynchroMed® II Drug Infusion System Brief Summary at the end of this presentation for important risk and safety information.

15. What is Targeted Drug Delivery?
An alternate route of delivering pain medications
An implantable infusion system delivers pain medication to the site of action, the cerebrospinal fluid and spinal cord, to directly affect pain pathways
Physician programs dosing and delivery parameters
myPTM® allows patients to deliver boluses of medication within physician-prescribed limits
In contrast, oral and transdermal pain medications must be absorbed systemically and cross “blood-brain barrier” to reach pain signals

16. Systemic vs. Targeted Delivery of Medications
Systemic Analgesia
Distributes drug via blood stream
High blood levels of drug
Brain receives highest proportion of drug
High dose of drug required (high elimination load)
Increase in systemic side effects
Spinal Analgesia
Intrathecal drug distribution
Low blood levels of drug
Most drug binds to TARGET (spinal cord pain receptors)
Low dose of drug is effective (low elimination load)
Reduced systemic effect on brain and gut
With systemic analgesia, whether it is oral, transdermal, or another route of systemic delivery, the drug is distributed via the blood stream. Systemic delivery results in high blood levels of the drug, with the brain receiving the highest proportion. Due to a high elimination load, high doses of the drug are required, which may result in increased systemic side effects.
Spinal analgesia targets the delivery of the drug intrathecally, directly into the cerebral spinal fluid in the spinal column. Targeted drug delivery results in low blood levels of the drug. Since most of the drug binds to the target or spinal cord pain receptors, a low dose of the drug can be effective, resulting in a low elimination load and reduced systemic effects on the gut and brain.

17. Targeted Drug Delivery
Trial
Patients can trial the therapy
Bolus or in-dwelling catheter
Assess for improvements in:
Pain scores
Physical function
Adverse events
Successful trial can be followed by implant
Implant
Implantation of infusion pump and intrathecal catheter
myPTM® is optional for appropriate patients
Drug Trial Purpose
Assess efficacy of drug administration for pain management.
Allow physician to assess potential of achieving goals set during patient selection.
Sufficient pain relief (for cancer patients, may be only goal assessed)
Increased functioning
Reduced side effects from systemic analgesics
Decreased use of systemic analgesics
Evaluating Trial Results
Measurement tools
Subjective: Pain diary, pain scores
Objective: Monitor activities, monitor medications
Assess results against pre-trial goals established.
Trial outcome is positive when goals are met.
General Implant
Product verified
Patient positioned and prepped
Needle placed
Catheter inserted
Pump prepared and pump pocket created
Catheter tunneled subcutaneously
Catheter connected to the pump
Pump placed in pocket and sutured to fascia
Pump programmed (if programmable pump)

18. Targeted Drug Delivery
Distinguishing characteristics:
Graphic #1 notes
It’s important to remember that Targeted Drug Delivery is not a therapy—it is a delivery system for a therapy. For pain, morphine or ziconotide is the therapy.
Graphic #2 notes
The patient therapy manager or myPTM is an exclusive feature of the SynchroMed programmable infusion system.
The patient controls activated bolus doses to address intermittent pain when needed.
Doses and delivery parameters remain within physician-set limits.
Do not use myPTM to administer morphine to opioid-naive patients or to administer ziconotide.
Graphic #3 notes
300,000 Medtronic Targeted Drug Delivery pumps have been implanted worldwide.
SynchroMed II stands the test of time. Only SynchroMed II has documented 97.6% device survival with on-label drugs at 6.5 years.1
Medtronic data on file Addendum to the Medtronic Neurostimulation & Intrathecal Drug Delivery Systems Product Performance Report
Hamza M, Doleys D, Wells M, et al. Prospective study of 3-year follow-up of low-dose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. 2012;13(10):
Ellis DJ, Dissanayake S, McGuire D, et al. Continuous intrathecal infusion of ziconotide for treatment of chronic malignant and nonmalignant pain over 12 months: a prospective, open-label study. Neuromodulation. 2008;11(1):40-49.
Medtronic data on file. Approximately 122,000 implanted devices x 8760 patient-hours per year.
* Please refer to the Neurostimulation Systems for Pain Therapy Brief Summary and the SynchroMed® II Drug Infusion System Brief Summary at the end of this presentation for important risk and safety information.

19. Why Medtronic?
Medtronic is the only company supporting physicians and payers with Level 1 clinical evidence documenting the effectiveness of spinal cord stimulation and targeted drug delivery1-5
Top-level of scientific evidence
Randomized Controlled Trials
Importance
100% of evidence-based coverage policies rely on data during assessment of therapies6
100% of published Randomized Controlled Trials concerning implanted spinal cord stimulation or intrathecal drug delivery systems used Medtronic products to demonstrate efficacy for approved indications in the United States1-7
Level 1 is the top-level of scientific evidence in the evidence pyramid. It means properly designed Randomized Controlled Trials are used. Medtronic is the only company supporting physicians and payers with Level 1 clinical evidence documenting the effectiveness of spinal cord stimulation and targeted drug delivery.1-5
Why is this important?
100% of evidence-based coverage policies rely on data during assessment of therapies.6
100% of published Randomized Controlled Trials concerning implanted spinal cord stimulation or intrathecal drug delivery systems used Medtronic products to demonstrate efficacy for approved indications in the United States.1-7
North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1):
Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):
Smith TJ, Staats PS, Deer T, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002;20(19):
Rauck RL, Wallace MS, Leong MS, et al. A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain. J Pain Symptom Manage. 2006;31(5):
Raphael JH, Duarte RV, Southall JL, Nightingale P, Kitas GD. Randomised, double-blind controlled trial by dose reduction of implanted intrathecal morphine delivery in chronic non-cancer pain. BMJ Open. 2013;3(7):e
Kemler MA, Barendse GA, van Kleef M, et al. Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy. N Engl J Med. 2000;343(9):
Schultz DM, Webster L, Kosek P, Dar U, Tan Y, Sun M. Sensor-driven, position-adaptive spinal cord stimulation for chronic pain. Pain Physician. 2012;15:1-12.
References provided on next slide.

20. Why Medtronic? References
North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1):
Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):
Smith TJ, Staats PS, Deer T, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002;20(19):
Rauck RL, Wallace MS, Leong MS, et al. A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain. J Pain Symptom Manage. 2006;31(5):
Raphael JH, Duarte RV, Southall JL, Nightingale P, Kitas GD. Randomised, double-blind controlled trial by dose reduction of implanted intrathecal morphine delivery in chronic non-cancer pain. BMJ Open. 2013;3(7):e
Kemler MA, Barendse GA, van Kleef M, et al. Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy. N Engl J Med. 2000;343(9):
Schultz DM, Webster L, Kosek P, Dar U, Tan Y, Sun M. Sensor-driven, position-adaptive spinal cord stimulation for chronic pain. Pain Physician. 2012;15:1-12.

21. Why Medtronic? MR Conditional
Neurostimulation systems—safe access to 1.5-Tesla MRI scans on any part of body*
SynchroMed® infusion systems— safe full-body access to 1.5- and Tesla MRI scans and resume programmed therapy after scan†
You can’t predict the future, but you can be ready for it
Medtronic recently released its SureScan® MRI family of pain neurostimulators—the first and only SCS system FDA approved for conditionally safe MRI scans anywhere on the body.* While Medtronic and other companies have invested heavily to globally commercialize their MR Conditional cardiac pacemakers, Medtronic is the first to provide this exclusive technology to help you serve the chronic pain population.
Q & A
“What is the difference between MR Conditional and MR Safe?”
MR Safe - an item that poses no known hazards in all MRI environments. Using the terminology, “MR Safe” items are non-conducting, non-metallic, and non-magnetic items such as a plastic Petri dish.1
MR Conditional - an item that has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use.1
“Are CT and other diagnostic imaging modalities sufficient to diagnose my patients’ conditions?”
ACR guidelines are the gold standard for radiology – evidence-based guidelines have been created by industry experts to highlight conditions where MRI is the only preferred imaging modality for patients.2
4,500+ peer-reviewed papers from the past 40+ years were evaluated and imaging modalities were rated on a 9-grade scale, with 9 being the most appropriate alternative.3
*Under specific conditions; requires SureScan® implantable neurostimulator and Vectris® leads. Refer to approved labeling for full list of conditions.
American Society for Testing and Materials (ASTM) International, Designation: F , Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. ASTM International, West Conshohocken, PA.
Expert Panel on MR Safety, Kanal, E, et al. ACR guidance document on MR safe practices: J Magn Reson Imaging. 2013;37(3):501–530. doi: /jmri Accessed November 8, 2013 (
American College of Radiology. ACR Appropriateness Criteria® available at Accessed October 31, 2013.
MR Conditional—These devices are FDA approved for MR Conditional safe labeling under specific conditions. See approved labeling.
*Under specific conditions; requires SureScan® implantable neurostimulator and Vectris® leads. Refer to approved labeling for full list of conditions.
†Under specific conditions; requires interrogation to confirm pump status. Refer to approved labeling for full list of conditions.

22. Spinal Cord Stimulation Evidence*
Long-term pain relief1,2
Improved quality of life1,2
More effective than repeat surgery for persistent radicular pain after lumbosacral spine surgery3
Successful pain disability reduction2
More cost-effective than conventional medical management and reoperation4,5
Kumar K, Taylor RS, Jacques L, et al. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery. 2008;63(4): ;discussion 770.
Harke H, Gretenkort P, Ladleif HU, Rahman S. Spinal cord stimulation in sympathetically maintained complex regional pain syndrome type I with severe disability. A prospective clinical study. Eur J Pain. 2005:9(4);
North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1): Taylor RJ, Taylor, RS. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effective analysis. Int J Technol Assess Health Care. 2005;21:
Taylor RJ, Taylor, RS. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effective analysis. Int J Technol Assess Health Care. 2005;21(3):
North RB, Kidd D, Shipley J, Taylor RS. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost effectiveness and cost utility analysis based on a randomized, controlled trial. Neurosurgery. 2007;61(2):
* Please refer to the Neurostimulation Systems for Pain Therapy Brief Summary and the SynchroMed® II Drug Infusion System Brief Summary at the end of this presentation for important risk and safety information.

23. Targeted Drug Delivery Evidence*
Effective pain relief1-7
Reduced or eliminated use of pain medication4-6
Return-to-work data4
Improved clinical success in pain control, reduced pain, and significantly relieved common drug toxicities1 5
Smith TJ, Staats PS, Deer T, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002;20(19):
Rauck RL, Wallace MS, Leong MS, et al. A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain. J Pain Symptom Manage. 2006;31(5):
Raphael JH, Duarte RV, Southall JL, Nightingale P, Kitas GD. Randomised, double-blind controlled trial by dose reduction of implanted intrathecal morphine delivery in chronic non-cancer pain. BMJ Open. 2013;3(7):e
Deer T, Chapple I, Classen A, et al. Intrathecal drug delivery for treatment of chronic low back pain: report from the National Outcomes Registry for Low Back Pain. Pain Med. 2004;5(1):6-13.
Hamza M, Doleys D, Wells M, et al. Prospective study of 3-year follow-up of low-dose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. 2012;13(10):
Atli A, Theodore BR, Turk DC, Loeser JD. Intrathecal opioid therapy for chronic nonmalignant pain: a retrospective cohort study with 3-year follow-up. Pain Med. 2010;11(7):
Ellis DJ, Dissanayake S, McGuire D, et al. Continuous intrathecal infusion of ziconotide for treatment of chronic malignant and nonmalignant pain over 12 months: a prospective, open-label study. Neuromodulation. 2008;11(1):40-49.
* Please refer to the Neurostimulation Systems for Pain Therapy Brief Summary and the SynchroMed® II Drug Infusion System Brief Summary at the end of this presentation for important risk and safety information.

24. Risks
Spinal Cord Stimulation risks may include infection or pain at the implant site, epidural bleeding, device complications that may require surgery, undesirable change in neurostimulation resulting in uncomfortable shocking stimulation, loss of therapy effect, lead fracture, migration or dislodgement, and therapy that does not meet patient expectations.
Targeted Drug Delivery risks may include infection, spinal fluid leak, pump inversion, skin erosion, drug side effects (including under- or overdose), loss of therapy effect, and therapy that does not meet patient expectations.
Please refer to the Neurostimulation Systems for Pain Therapy Brief Summary and the SynchroMed® II Drug Infusion System Brief Summary on the back of this sheet for additional risk and safety information.

25. Patient Selection for Medtronic Pain Therapies
Does the patient have chronic pain that has not responded effectively to more conventional treatments?
Have clear, functional patient goals been established?
Do patients and caregivers have realistic pain relief expectations?
To help you select patients who may be appropriate for Medtronic Pain Therapies, ask yourself these questions:
Does the patient have chronic pain that has not responded effectively to more conventional treatments?
Have clear, functional patient goals been established?
Do patients and caregivers have realistic pain relief expectations?
The chart on the right gives examples of chronic intractable pain that may be treated with spinal cord stimulation and targeted drug delivery.
It’s helpful to keep in mind that:
Patients who have neuropathic pain may respond best to spinal cord stimulation therapy.
Patients who have nociceptive pain may respond best to Targeted Drug Delivery.
Patients who do not respond well to spinal cord stimulation may be candidates for Targeted Drug Delivery.

26. — Medtronic Targeted Drug Delivery patient
Patient Expectations
Establish specific, measureable goals
Ensure patients have realistic expectations and ability to participate in a comprehensive treatment plan
Discuss the importance of the trial
“My expectation after the trial is that I knew it would work. Before the trial, I was very hesitant. The most important thing is the trial. The trial is the thing that tells you if it works or if it doesn’t.*”
— Medtronic Targeted Drug Delivery patient
Goal examples
Pain control with reduction of oral medications
Reduction of side effects
Improved activities of daily living (ADLs) – Gardening, shopping, holding grandchildren
Increased range of motion, ambulation
Reduced hospital or ER visits
Return to work
Ultimate goal: improved quality of life
Set expectations
Variety of healthcare professionals may collaborate/interact throughout treatment process
Pain management specialist role—advanced chronic pain treatment options, including Medtronic Pain Therapies
If Medtronic Pain Therapy indicated, patients can “trial” device first—without implantation—helps determine effectiveness
Point out these patients in the graphic:
*Medtronic Inc. Foundational Message Development for Patients Suffering from Chronic Pain. Qualitative Market Report. Oct
Linda B., Failed Back Surgery Syndrome, Neurostimulation, Implant Date 2012.
Tanya B., Chronic back pain, 2010 RestoreSensor® Clinical Study Patient, using AdaptiveStim® exclusively available with RestoreSensor®, FDA approved 2011.
Hank E., Failed Back Surgery Syndrome, Targeted Drug Delivery, Implant Date: 2009.

27. Medtronic Tools and Resources
professional.medtronic.com
Medtronic healthcare professionals website: professional.medtronic.com—provides information on Medtronic Pain Therapies, products, and more.

28. Clinician Support
Targeted Drug Delivery: professional.medtronic.com/tdd
Information on Targeted Drug Delivery, including Approaches to Targeted Drug Delivery videos can be accessed at: professional.medtronic.com/tdd

29. Clinician Support Spinal Cord Stimulation: adaptivestim.com
Information on Spinal Cord Stimulation, including an in-depth look at AdaptiveStim® can be accessed at: adaptivestim.com

30. Clinician Support
Product Performance Report: professional.medtronic.com/performance
Training and education courses for healthcare professionals
E-learning
Contact your Medtronic representative to take advantage of varied opportunities
Only Medtronic publishes an annual Neurostimulation and Intrathecal Drug Delivery Systems Product Performance Report that provides:
device survival estimates of Medtronic’s commercially available implantable products.
data on more than 23,000 implanted devices and 8,200 patients.
Access the Product Performance Report at: professional.medtronic.com/performance
Also, several training and education courses are available. Contact your Medtronic representative—and take advantage of the many opportunities for healthcare professionals.

31. Patient Support Patient brochures and posters
Tame the Pain website: tamethepain.com
Physician Finder: tamethepain.com
Patient Ambassador Program: tamethepain.com/painambassador
Converse with a Nurse Program: tamethepain.com/nurse
Medtronic Living Well Program: medtroniclivingwell.com
Patient videos: youtube.com/medtronicchronicpain
Just to clarify …
Patient Ambassador Program (tamethepain.com/painambassador) connects prospective patients with volunteers who are willing to share their personal experience with a Medtronic Pain Therapy.
Converse with a Nurse Program (tamethepain.com/nurse) provides opportunity for patients considering Medtronic Pain Therapies or those already implanted to connect with a nurse expert. Unlike the patient ambassadors, who are volunteers, these nurses are compensated by Medtronic.

32. Patient Support
tamethepain.com

33. What Questions Do You Have?

34. Thank You

35. Neurostimulation Systems for Pain Therapy Brief Summary
Product Technical Manuals and Programming Guides must be reviewed prior to use for detailed disclosure.
Indication for Use - Chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain. Contraindications: Diathermy. Warnings: Defibrillation, diathermy, electrocautery, MRI, RF ablation, & therapeutic ultrasound can result in unexpected changes in stimulation, serious patient injury or death. Rupture/piercing of neurostimulator can result in severe burns. Electrical pulses from the neurostimulator may result in an inappropriate response of the cardiac device. Precautions: The safety and effectiveness of this therapy has not been established for: pediatric use, pregnancy, unborn fetus, or delivery. Follow programming guidelines & precautions in product manuals. Avoid activities that stress the implanted neurostimulation system. EMI, postural changes, & other activities may cause shocking/jolting. Patients using a rechargeable neurostimulator should check for skin irritation or redness near the neurostimulator during or after recharging. Adverse Events: Undesirable change in stimulation; hematoma, epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief, chest wall stimulation, & surgical risks.
For full prescribing information, please call Medtronic at and/or consult Medtronic’s website at
USA Rx Only Rev 0313

36. SynchroMed® II Drug Infusion System Brief Summary
Product technical manuals and the appropriate drug labeling must be reviewed prior to use for detailed disclosure.
Indications:
US: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, and chronic intrathecal infusion of Lioresal® Intrathecal (baclofen injection) for the management of severe spasticity; chronic intravascular infusion of floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer. Outside of US: Chronic infusion of drugs or fluids tested as compatible and listed in the product labeling.
Contraindications:
Infection; implant depth greater than 2.5 cm below skin; insufficient body size; spinal anomalies; drugs with preservatives, drug contraindications, drug formulations with pH ≤3, use of catheter access port (CAP) kit for refills or of refill kit for catheter access, blood sampling through CAP in vascular applications, use of Personal Therapy Manager to administer opioid to opioid-naïve patients or to administer ziconotide.

37. SynchroMed® II Drug Infusion System Brief Summary
Warnings:
Non-indicated formulations may contain neurotoxic preservatives, antimicrobials, or antioxidants, or may be incompatible with and damage the system. Failure to comply with all product instructions, including use of drugs or fluids not indicated for use with system, or of questionable sterility or quality, or use of non-Medtronic components or inappropriate kits, can result in improper use, technical errors, increased risks to patient, tissue damage, damage to the system requiring revision or replacement, and/or change in therapy, and may result in additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug under- or overdose. Refer to appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration information, screening procedures and underdose and overdose symptoms and methods of management. Physicians must be familiar with the drug stability information in the product technical manuals and must understand the dose relationship to drug concentration and pump flow rate before prescribing pump infusion. Implantation and ongoing system management must be performed by individuals trained in the operation and handling of the infusion system. An inflammatory mass that can result in serious neurological impairment, including paralysis, may occur at the tip of the implanted catheter. Clinicians should monitor patients on intraspinal therapy carefully for any new neurological signs or symptoms, change in underlying symptoms, or need for rapid dose escalation.

38. SynchroMed® II Drug Infusion System Brief Summary
Warnings:
Inform patients of the signs and symptoms of drug under- or overdose, appropriate drug warnings and precautions regarding drug interactions, potential side effects, and signs and symptoms that require medical attention, including prodromal signs and symptoms of inflammatory mass. Failure to recognize signs and symptoms and seek appropriate medical intervention can result in serious injury or death. Instruct patients to notify their healthcare professionals of the implanted pump before medical tests/procedures, to return for refills at prescribed times, to carry their Medtronic device identification card, to avoid manipulating the pump through the skin, to consult with their clinician if the pump alarms and before traveling or engaging in activities that can stress the infusion system or involve pressure or temperature changes. Strong sources of electromagnetic interference (EMI), such as short wave (RF) diathermy and MRI, can negatively interact with the pump and cause heating of the implanted pump, system damage, or changes in pump operation or flow rate, that can result in patient injury from tissue heating, additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug underdose or overdose. Avoid using shortwave (RF) diathermy within 30 cm of the pump or catheter. Effects of other types of diathermy (microwave, ultrasonic, etc.) on the pump are unknown. Drug infusion is suspended during MRI; for patients who can not safely tolerate suspension, use alternative drug delivery method during MRI. Patients receiving intrathecal baclofen therapy are at higher risk for adverse events, as baclofen withdrawal can lead to a life threatening condition if not treated promptly and effectively. Confirm pump status before and after MRI. Reference product labeling for information on sources of EMI, effects on patient and system, and steps to reduce risks from EMI.

39. SynchroMed® II Drug Infusion System Brief Summary
Precautions:
Monitor patients after device or catheter replacement for signs of underdose/overdose. Infuse preservative-free (intraspinal) saline or, for vascular applications, infuse heparinized solutions therapy at minimum flow rate if therapy is discontinued for an extended period of time to avoid system damage. EMI may interfere with programmer telemetry during pump programming sessions. EMI from the SynchroMed programmer may interfere with other active implanted devices (e.g., pacemaker, defibrillator, neurostimulator).
Adverse Events:
Include, but are not limited to, spinal/vascular procedure risks; infection; bleeding; tissue damage, damage to the system or loss of, or change in, therapy that may result in additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug underdose or overdose, due to end of device service life, failure of the catheter, pump or other system component, pump inversion, technical/programming errors, or improper use, including use of non-indicated formulations and/or not using drugs or system in accordance with labeling; pocket seroma, hematoma, erosion, infection; post-lumbar puncture (spinal headache); CSF leak and rare central nervous system pressure-related problems; hygroma; radiculitis; arachnoiditis; spinal cord bleeding/damage; meningitis; neurological impairment (including paralysis) due to inflammatory mass; potential serious adverse effects from catheter fragments in intrathecal space, including potential to compromise antibiotic effectiveness for CSF infection; anesthesia complications; body rejection phenomena; local and systemic drug toxicity and related side effects; potential serious adverse effects from catheter placement in intravascular applications.
Lioresal® is a registered trademark of Medtronic, Inc. USA Rx Only Rev 0911