1. Medtronic Pain Therapies Referral Strategies for Managing Chronic Pain
© Medtronic, Inc. 2008

2. Agenda Types of Pain Common Chronic Pain Conditions
Introduction to Medtronic Neurostimulation
Introduction to Medtronic Intrathecal Drug Delivery
Patient Selection
Neurostimulation Clinical Evidence
Intrathecal Drug Delivery Clinical Evidence
Role of Interventional Pain Specialist
Case Study
Welcome. We’ll be covering the items above during this presentation.
We’ll start with an introduction to pain and common and pain conditions, then move into neurostimulation and intrathecal drug delivery from Medtronic.
I’ll share with you clinical evidence for these therapies before outlining how you can work most effectively with an interventional pain specialist.
We’ll finish up by discussing a compelling case study.
© Medtronic, Inc. 2008

3. Types of Pain © Medtronic, Inc. 2008
Let’s begin by looking at different types of pain.
© Medtronic, Inc. 2008

4. Pain Definitions
The IASP defines pain as “an unpleasant sensory and emotional experience associated with actual or perceived tissue damage or described in terms of such damage”1
Pain can be classified according to primary etiology2
Neuropathic
Nociceptive
Mixed neuropathic and nociceptive
All types of pain can also be classified by duration3
Acute: less than 6 weeks
Sub-acute: between 6 weeks and 3 months
Chronic: lasting > 3-6 months
There are several definitions of pain. The most widely accepted one is shown here from the International Association for the Study of Pain.
This definition:
Acknowledges the complexity of the pain experience
Emphasizes the emotional and sensory aspects of pain
Includes the contribution of actual tissue damage
Makes allowances for pain in the absence of identifiable damage
It is important to note that pain can be classified according to etiology and duration.
© Medtronic, Inc. 2008
1 Merskey H, Bogduk N, eds. Classification of Chronic Pain, 2nd Ed. IASP Press Seattle, 1994
2 Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg
3 Koes BW, et al. Br Med J. 2006;332:

5. Types of Neuropathic Pain
Direct nerve root injury: radiculopathy
Battered root syndrome
Perineural fibrosis
Intrafascicular fibrosis
Adhesive arachnoiditis
Peripheral deafferentation
Phantom limb pain
Sympathetic-mediated pain syndrome
Herpetic neuralgia
Diabetic polyneuropathy
Central deafferentation-thalamic stroke
Here are some examples of neuropathic pain.
© Medtronic, Inc. 2008
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg

6. Types of Nociceptive Pain
Mechanical low back pain
Discogenic pain
Joint pain
Facet joint
Sacroiliac joint
Pseudoarthrosis
Osteoporosis
Musculoskeletal trauma
Here are some examples of nociceptive pain.
© Medtronic, Inc. 2008
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg

7. Combined Nociceptive and Neuropathic Pain
Failed Back Surgery Syndrome (FBSS)*
Idiopathic chronic pain syndrome
Cancer pain
*Also referred to as “post-surgical chronic back pain”
Some pain exhibits characteristics of both nociceptive and neuropathic pain.
© Medtronic, Inc. 2008
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg

8. Chronic Pain
Continuous or intermittent pain that has persisted for at least 3-6 months
Severe chronic pain results in high disability and severe limitation of ability to work or complete daily activities
Patients should not have to wait three to six months for effective pain treatment. Pain management techniques differ significantly once pain becomes chronic. Initiating timely pain management interventions in the acute setting may prevent pain from becoming chronic.
© Medtronic, Inc. 2008
Smith BH, et al. Fam Pract. 2001;18:

9. Many Americans Suffer
Approx. 30 million Americans suffer from moderate to severe non-cancer-related chronic pain1
Chronic pain results in over 40 million doctor visits and 515 million lost workdays annually2
Approx. 300,000 back surgeries are performed in the U.S. per year to treat chronic lumbar pain with failure rates as high as 40%3
The success rate decreases significantly with each subsequent back surgery4
Chronic pain statistics are staggering. Consider:
46% have constant pain5
59% have had pain for 2-15 years5
19% have lost their job because of their pain5
21% are diagnosed with depression because of their pain5
5. Brahvik H et al. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain 16: [Confirm reference. Cannot read on video screen. Source is: Medtronic Movie.]
© Medtronic, Inc. 2008
1. Chronic Pain in America: Roadblocks to Relief, avail at 2. Business Week, March 1, 1999; 3. Deer T, et al. Pain Med. 2004; 5:6-13;
4. Miller B, et al. Pain Practice. 2005;5:

10. Common Chronic Pain Conditions
Now we’ll look at some common chronic pain conditions.
© Medtronic, Inc. 2008

11. Chronic Pain Conditions
Post-surgical chronic back pain or failed back
Radicular pain syndrome or radiculopathies resulting in pain secondary to failed back or herniated disk
Postlaminectomy pain
Multiple back operations
Unsuccessful disk surgery
Degenerative disk disease, herniated disk pain refractory to conservative and surgical interventions
Peripheral causalgia
Epidural fibrosis
Arachnoiditis or lumbar adhesive arachnoiditis
Complex regional pain syndrome, reflex sympathetic dystrophy or causalgia
[Speak to the slide.]
© Medtronic, Inc. 2008

12. Complex Regional Pain Syndrome (CRPS)
Chronic pain syndrome characterized by severe pain with autonomic changes in the painful region
Affects up to 1.2 million Americans1-3
Develops in response to a traumatic physical event (e.g., accident or medical procedure)
May respond to neurostimulation therapy
I’ll talk further about two forms of chronic pain—Complex Regional Pain Syndrome and Post-Surgical Chronic Back Pain (sometimes referred to as Failed Back Surgery Syndrome). Both respond well to the Medtronic Pain Therapies that we’ll be highlighting later in the presentation.
Complex Regional Pain Syndrome is chronic pain that typically affects the arm or leg. The nature of the syndrome is puzzling and the cause is not completely understood.
Autonomic changes may include:
Edema
Temperature abnormalities
Sudomotor activity
Skin color changes
Even “minor” accidents—like a sprain—can be the cause of CRPS. CRPS causes nerves to misfire, sending constant pain signals to the brain.
© Medtronic, Inc. 2008
1 Stanton-Hicks MD. An update interdisciplinary clinical pathway for CRPS: report of an expert panel. Pain Practice 2002; vol 2, no ; 2 Reflex Sympathetic Dystrophy Syndrome Association (RSDA). CRPS Treatment Guidelines. June 2006; 3 RSDA. CRPS/RSD Fact Sheet, CRPS Treatment Guidelines. June 2006

13. Failed Back Surgery Syndrome
Structural causes can be identified post-operatively by CT scan, MRI, myelogram, or x-ray
If no structural cause can be found, persistent pain may be neuropathic—caused by the prolongation of the original condition and/or by the additional physical impact of invasive surgery
Patients may be candidates for neurostimulation therapy
In the United States, Post-Surgical Chronic Back Pain affects 20% to 40% of patients who undergo spinal surgery each year.1,2
1. North RB et al. Neurosurgery. 2005;56:
2. Stojanovic MP. Curr Pain Head Rep. 2001;5:
© Medtronic, Inc. 2008

14. Pain Management Treatment Options
Because of the number of physicians chronic pain patients typically see, an open dialogue among these healthcare professionals is needed for:
Sharing pertinent patient information
Coordination of treatment plan
Enabling roundtable of multidisciplinary expertise for considering treatment options
Providing timely, appropriate, cost-effective treatment, thus increasing the quality of health care and quality of life for patients with chronic pain
© Medtronic, Inc. 2008
De Andrés J, Van Buyten J-P. Pain Practice. 2006;6:39-45

15. Barriers to Effective Pain Management
This chart is an overview of the barriers to pain treatment that must be addressed if we are to effectively treat chronic pain. As you can see, the barriers can be found within the healthcare system, with healthcare professionals and with the patient.
You play an important role in helping your patients overcome these barriers so their pain can be effectively managed.
© Medtronic, Inc. 2008
Lyn ME, Coyne PJ, Watson AC. Pain Management Issues for Cancer Survivors. Cancer Practice. May/June 2002; Vol. 10, Suppl.1

16. Is Oral Opioid Therapy Effective for Chronic Pain?
Short-term efficacy
RCTs and observational studies demonstrate improvement in pain
No evidence to support dosing >180 mg morphine equivalent per day
Long-term efficacy
No RCTs for longer than 8 months
Overall evidence is weak
No evidence of improved function
Oral opioid use remains the mainstay of analgesic medications for treating both acute and chronic pain.1 Clinical and preclinical studies indicate that prolonged use of oral opioids may have adverse consequences, including opioid tolerance, with the need for dose escalation and opioid-induced abnormal pain sensitivity.
Current guidelines recommend a cautious approach to dose escalation and discontinuation of opioids if treatment goals are not met.2
1.Pappazallo M, Henberg LJ. Ethical Isuses in the Management of Chronic Nonmalignant Pain. Semin Neurol. 1997;17(3):
2.Ballantyne JC, Mao J. Opioid Therapy for Chronic Pain. N Engl J Med. 2003; 349:
© Medtronic, Inc. 2008
Ballantyne JC, Mao J. N Engl J Med, 2003;349:

17. Device therapies are now considered earlier in the treatment continuum
Pain Treatment Ladder
Device therapies are now considered earlier in the treatment continuum
The Stamatos version of the Pain Treatment Ladder proposes focusing on the area causing the pain, rather than treating the whole body.
In contrast to the traditional treatment ladder approach, interventional therapies, corrective surgery, and neurostimulation are placed before long-term opioid therapy.
This allows targeting of medication or therapy to the specific area of pain before a more general pain treatment approach is applied.
© Medtronic, Inc. 2008
Stamatos JM, et al. Live Your Life Pain Free, October Based on the interventional pain management experience of Dr. John Stamatos

18. Introduction to Medtronic Neurostimulation
Now we’ll discuss implantable pain therapies including neurostimulation—also known as spinal cord stimulation—and intrathecal drug delivery.
Both therapies have been proven to be effective in managing pain for those patients experiencing moderate to severe chronic pain that cannot be alleviated using other methods.1,2
We’ll begin with neurostimulation.
Burchiel K, Anderson V, et al. Prospective, Multicenter Study of Spinal Cord Stimulation for the Relief of Chronic Back and Extremity Pain. Spine. 1996; 21:
Winkelmuller M, Winkelmuller W. Long-term Effects of Continuous Intrathecal Opioid Treatment in Chronic Pain of Non-malignant Etiology. J Neurosurg. 1996; 35: [Note: page numbers appear this way in Practicum presentation]
© Medtronic, Inc. 2008

19. Neurostimulation Therapy
Delivers small electrical signals to the epidural space
Inhibits pain signals before they reach the brain and replaces them with a tingling sensation that covers the specific areas where pain was felt
Indicated for treatment of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain
The neurostimulator system consists of:
A small electronic system called the neurostimulator, which creates the impulses to block the pain signals from reaching the brain
A lead through which electrical stimulation is delivered to the spinal cord
An extension that connects the lead to the neurostimulator
© Medtronic, Inc. 2008

20. Neurostimulation Indication
Medtronic Neurostimulation Systems are indicated for treatment of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain
[Speak to the slide.]
© Medtronic, Inc. 2008

21. History of Neurostimulation
1962
1967
1970s
1980
1982
Today
First carotid sinus nerve stimulator
First “dorsal column” stimulator
Spinal cord stimulator widely used
Medtronic introduces first programmable electrode system in U.S.
First clinical implant of Itrel® totally implantable neurostimulator
More than 100,000 patients have received Medtronic neurostimulation therapy for chronic pain
[Speak to the slide. Emphasize that Medtronic has been engineering neurostimulation systems since 1980.]
© Medtronic, Inc. 2008

22. Benefits of Neurostimulation
An effective method of pain control for many patients
Reduces or eliminates pain medications
Non-destructive and less invasive than surgical alternatives
Reversible – can be discontinued or surgically removed
Systems reprogrammable without surgery
Trial helps assess patient response
Patient control within physician-set limits
[Speak to the slide. Stress that implantation of a neurostimulator system is a minimally invasive surgery. The system can be removed at any time. The trial allows the patient to try the system prior to implant.]
© Medtronic, Inc. 2008
Kumar K, Nath RK, Toth C. Deep Brain Stimulation for Intractable Pain: A 15-year experience. Neurosurgery. 1997

23. Neurostimulation Trial
Pain Therapy Trial provides an opportunity to measure the effectiveness of neurostimulation without making a long-term commitment
Gauge patient response
Provide an adjustment period
Explore therapy parameters
Improve therapy cost-effectiveness
The goal is at least a 50% reduction in pain without intolerable side effects
Patient-specific goals may include less pain reduction but improved quality of life
Candidates for neurostimulation undergo a trial to help predict the success of this therapy.
During the trial, patients should experience at least a 50% reduction in pain, without intolerable side effects.
© Medtronic, Inc. 2008
Kumar K, et al. Neurosurgery. 2006;58:

24. Neurostimulation Trial
A percutaneous lead is positioned in the epidural space on the dorsal aspect of the spinal cord at the appropriate nerve root level(s)
Electrical current from the lead generates paresthesias that can be adjusted in intensity and location to achieve the best pain coverage
Leads are attached to an external pulse generator which supplies the current
Patients can adjust stimulation to meet pain management needs
The physician has a choice of two screening techniques: placing a temporary percutaneous lead or implanting a percutaneous or surgical lead.
Advantages of the temporary lead method include shorter time in the operating room and less trauma for the patient.
Advantages of the permanent lead method include maintenance of optimal lead positioning and lower cost because the lead(s) does not need to be replaced with a new lead(s) at permanent implant.
© Medtronic, Inc. 2008

25. Neurostimulation Implantation
An incision is made over the spine to place lead
A pocket is formed under the skin to hold the neurostimulator
The lead is tunneled under the skin and connected to the neurostimulator
The lead is connected to the neurostimulator, incisions are closed, and the procedure is complete
[Speak to the slide.]
© Medtronic, Inc. 2008

26. Neurostimulation Procedure Overview
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27. Some Risks of Neurostimulation
Lead migration resulting in loss of pain relief
Intermittent or uncomfortable stimulation
Stimulation in the wrong location
Neurological damage during procedure
Risk of infection at implantation
[Speak to the slide.]
For complete list of risks/complications, refer to product package insert
© Medtronic, Inc. 2008
North R, Kidd D, Zahurak M, et al. Neurosurgery. 1993;32:

28. RESTOREULTRA® System © Medtronic, Inc. 2008
This slide provides a visual of the complete RestoreULTRATM system including:
Patient trial system
External neurostimulator
Neurostimulator
Lead
N’Vision programmer
Screening cable
Patient programmer
© Medtronic, Inc. 2008

29. Introduction to Medtronic Intrathecal Drug Delivery
Now we’ll focus on Intrathecal Drug Delivery.
© Medtronic, Inc. 2008

30. Intrathecal Drug Delivery (IDD) Therapy
IDD therapy involves the delivery of pain medicine in the intrathecal space
The pump is connected to a thin, flexible catheter; both are implanted under the skin
Smaller doses of medication are needed for effective pain relief because drug is delivered directly to the pain receptors
Intrathecal drug delivery (IDD) uses a drug delivery system to place medication directly to the intrathecal space of the spine.
IDD consists of:
A round pump device that stores and delivers pain medication
A catheter that is connected to the pump and inserted into the spine
© Medtronic, Inc. 2008

31. Synchromed® II Drug Infusion System Indications
Chronic intrathecal infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain
Also indicated for chronic intrathecal infusion of Lioresal® Intrathecal (baclofen injection) for severe spasticity, chronic epidural infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, and chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain
When being used for chronic pain, the pump can be filled with:
Preservative-free morphine
Ziconotide sterile solution
© Medtronic, Inc. 2008
Lioresal® is a registered trademark of Novartis Pharmaceuticals, Inc.

32. History of Intrathecal Drug Delivery
1982
1988
1991
Today
First clinical implant of programmable pump (became SynchroMed pump) for intrathecal morphine
Market release of implantable programmable SynchroMed Pump (IV use for cancer chemotherapy)
Market release of SynchroMed Pump (intrathecal morphine for cancer pain and non-malignant pain)
More than 100,000 patients worldwide have a Medtronic pump for chronic pain
© Medtronic, Inc. 2008

33. Approximate Equivalent Daily Doses of Morphine
Route of Administration
Relative Potency (mg)*
Oral
Intravenous
Epidural
Intrathecal
300
100 20 1
Intrathecal Drug Delivery can provide significant pain control with a small fraction of the dose (as little as 1/300th) that would be required with oral medications. This helps minimize side effects.
*Relative approximations based on clinical observations
© Medtronic, Inc. 2008
Lamer TJ: Mayo Clin Proc. May 1994;69(5):

34. Benefits of IDD Therapy
Pain relief for patients who have not received adequate relief with conventional therapies
Reduction in adverse effects from oral opioids such as nausea, vomiting, sedation, and constipation
Decreased or elimination of oral analgesics
Increased ability to perform activities of daily living
Patient control within physician-set limits
May be effective for patients who do not experience relief from neurostimulation therapy
[Speak to the slide. Emphasize that because the drug is delivered directly to the intrathecal space, IDD offers significant pain control with lower doses of medication.]
© Medtronic, Inc. 2008
Lamer TJ: Mayo Clin Proc. May 1994;69(5):473-80; Paice JA, et al: J Pain Symptom Manage.1996;11(2):71-80.

35. IDD Trial
The purpose of the trial is to assess the efficacy and side effects of intrathecal morphine
Trialing methods include
Continuous epidural
Continuous intrathecal
Bolus epidural
Bolus intrathecal
Patients who report at least 50% reduction in pain may be candidates for long-term therapy
Candidates for IDD undergo a trial procedure to predict success with an implanted pump.
During the trial, patients should experience at least a 50% reduction in pain, without intolerable side effects to the test drug, to be considered for the therapy.
© Medtronic, Inc. 2008

36. IDD Implantation
An incision is made over the spine for insertion of the catheter
A pocket is formed under the skin to hold the IDD pump
The catheter is tunneled under the skin and connected to the IDD pump, incisions are closed, and the procedure is complete
[Speak to the slide.]
© Medtronic, Inc. 2008

37. Implant Procedure for IDD
[Describe the implant procedure.]
© Medtronic, Inc. 2008

38. IDD Therapy Risks Programming error Drug concentration error
Surgical complications, such as infection
Catheter could become dislodged or blocked
The pump could stop working
Other side effects may occur
[Speak to the slide.]
For complete list of risks/complications, refer to product package insert
© Medtronic, Inc. 2008
Onofrio BM, Yaksh TL. J Neurosurg 1990;72: ; Winkelmueller M, Winkelmueller W. J Neurosurg 1996;85: ; Paice JA, Penn RD, Shott S. J Pain Symptom Manage 1996;11(2):71-80

39. SynchroMed II Infusion System
This slide shows you the complete IDD system including:
Screening kit [confirm]
Programmable pump
Intrathecal Catheter
Programmer
Personal Therapy Manager
© Medtronic, Inc. 2008

40. Medtronic Pain Therapy Portfolio
The most comprehensive line of medical devices for management of chronic pain
Neurostimulation
Rechargeable and Non-rechargeable neurostimulation systems
mySTIM® patient programmer
Intrathecal Drug Delivery
Programmable pump
myPTM™
Medtronic has more than 30 years of experience pioneering, refining and implementing pain therapies technologies. Medtronic offers a family of consistently innovative pain solutions.
© Medtronic, Inc. 2008

41. Patient Selection
© Medtronic, Inc. 2008

42. Indications for Neurostimulation and Intrathecal Drug Delivery Therapy
Neurostimulation and Intrathecal Drug Delivery are indicated for a variety of chronic pain conditions.
A number of conditions can be treated with neurostimulation or intrathecal drug delivery. As a result, if a patient does not respond well to neurostimulation, IDD can be applied.
© Medtronic, Inc. 2008
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 362. Refer to full prescribing information for Medtronic Neurostimulation Systems and Synchromed® II and Isomed® Drug Infusion Systems

43. Patient Selection Considerations
Patients who have neuropathic pain in a concordant anatomic distribution respond best to neurostimulation (NS) therapy
Patients who have nociceptive pain in a concordant distribution respond best to Intrathecal Drug Delivery (IDD)
Patients who do not respond well to NS may be candidates for IDD therapy
[Speak to the slide. Stress the final bullet point.]
© Medtronic, Inc. 2008
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 362.

44. Patient Selection Checklist
Failure of oral/transdermal opiate use or undesirable side effects
More conservative therapies have failed
An observable pathology exists that is concordant with the pain complaint
Further surgical intervention is not indicated
No serious untreated drug habituation exists
Psychological evaluation and clearance for implantation has been obtained
No contraindications to implantation exist
Appropriate patients will have experienced inadequate pain relief and/or intolerable side effects from more conservative therapies.
A psychological evaluation should reveal a patient’s true expectations of the therapy.
After fulfilling the criteria listed above, the patient proceeds to a trial. This test helps predict success of the therapy.
Refer Patient for a Pain Therapy Trial
© Medtronic, Inc. 2008
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 362.

45. Neurostimulation Clinical Evidence
Both neurostimulation and intrathecal drug delivery have been thoroughly studied. We’ll begin with clinical evidence for neurostimulation.
© Medtronic, Inc. 2008

46. Medtronic PROCESS Study
Primary outcome
Number of patients with ≥50% leg pain relief at 6 months (≥50% reduction in leg VAS)
Secondary outcomes evaluated at 1, 3, 6, 9, 12, 18 and 24 months
Pain relief (leg and axial back VAS)
Quality of life (SF-36 and EQ-5D)
Function (Oswestry Disability Index)
Patient satisfaction
Need for drug or non-drug therapy for pain
Time away from work
Adverse events
The PROCESS study was a Medtronic-sponsored study completed in [confirm].
[Speak to the slide.]
© Medtronic, Inc. 2008
Kumar, et al. Pain 2007

47. Clinically Significant Leg Pain Relief
Key Findings: ≥50% leg pain relief at 24 months, continued greater effect with SCS* in the per treatment/ITT analyses over 24 months *SCS (spinal cord stimulation) is a term for neurostimulation
[Speak to the slide.]
© Medtronic, Inc. 2008
Kumar, et al. Pain 2007; n = 100

48. Significant Improvement in Function
[Speak to the slide.]
Key Findings: Significant improvement in function (Oswestry Disability Index) in SCS+CMM group over 24 months
© Medtronic, Inc. 2008
Kumar, et al. Pain 2007; n = 100

49. Significant Improvement in Quality of Life
Visual Analog Scale (VAS)
Key Findings: Significant improvement in SCS+CMM group in 7/8 domains of QoL (SF-36) over 24 months
[Speak to the slide. Stress mental health, role-emotional and general health results.]
© Medtronic, Inc. 2008
Kumar, et al. Pain 2007

50. High Satisfaction
Key Findings: Treatment satisfaction among patients continuing SCS+CMM at 24 months
At 24 months, 93% of the 42 patients continuing SCS+CMM declared that “based on their experience so far, they would have agreed to treatment.”
© Medtronic, Inc. 2008
Kumar, et al. Pain 2007; n = 100

51. Long-Term Pain Relief Key Findings:
61.3% of failed back surgery syndrome patients with bilateral limb pain and 59.3% of patients with unilateral limb pain reported >50%
[Speak to the slide.]
© Medtronic, Inc. 2008
Kumar, et al. Neurosurgery 2006

52. Neurostimulation is Most Effective When Considered Early
Success Rate (%)
[Stress difference in success rate at two years compared to 15 years.]
<2
2-5
5-8
8-11
11-15
>15
© Medtronic, Inc. 2008
Kumar K, et al. Neurosurg. 2006;58;

53. More Effective than Repeat Surgery
Key Findings:
Among patients available for long-term follow up, SCS was significantly more successful than reoperation: 9 (47%) of 19 patients randomized to SCS and 3 (12%) of 26 patients randomized to reoperation achieved at least 50% pain relief and were satisfied with treatment
[Speak to the slide.]
© Medtronic, Inc. 2008
North, et al. Neurosurgery 2005 ; n=45

54. 10-Year Experience: Neurostimulation Improves Quality of Life
27%
30%
42%
44%
[Speak to the slide. Stress increase in independence and ability to relax.]
© Medtronic, Inc. 2008
Van Buyten J-P, et al. Eur J Pain 2001;5: ; n=125 pain cases; P<0.01 for all activities

55. Intrathecal Drug Delivery Clinical Evidence
Following is clinical evidence pertaining to Intrathecal Drug Delivery.
© Medtronic, Inc. 2008

56. Back and Leg Pain Relief
Key Findings:
Numeric back pain ratings decreased >48%, and leg pain ratings decreased by 32% at 12-month follow up
[Speak to the slide.]
© Medtronic, Inc. 2008
Deer, et al. Pain Medicine 2004; n=136

57. Successful Disability Reduction
Key Findings:
Successful disability reduction was reported in 60% of patients at 6 months and in 66% at 12 months
[Speak to the slide.]
© Medtronic, Inc. 2008
Deer, et al. Pain Medicine 2004; n=136

58. Decreased Use of Pain Medications
88.2% of patients were taking systemic opioids at baseline
Key Findings:
At 6 months, 65% of patients decreased their use of systemic opioids from baseline
At 12 months, 42% of patients decreased their usage compared with the 6-month follow up
[Speak to the slide.]
© Medtronic, Inc. 2008
Deer, et al. Pain Medicine 2004; n=136

59. Overall Global Pain Relief
Number of Patients
Global Pain Relief (%)
Key Findings:
Overall pain relief of ≥50% was reported by 82% of patients (40 of 49)
[Speak to the slide.]
© Medtronic, Inc. 2008
Roberts, et al., European Journal of Pain; n=88

60. Clinical Evidence Summary
Neurostimulation
Clinically significant leg pain relief
Significant improvement
Function
Quality of life
High satisfaction
Long-term pain relief
Most effective when considered early
More effective than repeat surgery
Intrathecal Drug Delivery
Back and leg pain relief
Successful disability reduction
Decreased use of pain medication
Overall pain relief
Both neurostimulation and intrathecal drug delivery have been thoroughly studied. The studies highlighted in the previous slides are just a sampling of the research around these therapies. They confirm the benefits outlined above.
© Medtronic, Inc. 2008

61. Clinical Evidence Risks
As with any surgical procedure, neurostimulation and IDD involve the risk of infection. Lead migration is the most common complication associated with neurostimulation,1 while intrathecal catheters can fracture, kink, and migrate.2 For a complete list of adverse events for implantable therapies, see the appropriate product labeling.
[Speak to the slide.]
© Medtronic, Inc. 2008
1. Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review J Neurosrug (Spine 3)
100: , 2004; 2. Staats P. Complications of intrathecal therapy. Pain Medicine 2008; 9(S1):S102-S107

62. Role of Interventional Pain Specialist
© Medtronic, Inc. 2008

63. A Multidisciplinary Team Approach
Appropriate selection of pain therapy requires consideration of the physiological, psychological and social factors contributing to the condition. Creating a multidisciplinary team to foster communication between specialists is essential to effective pain management.
© Medtronic, Inc. 2008

64. Practice Management Collaboration
The roles of the referring physician and pain specialist are interdependent when treating chronic pain patients. Together, you play an important role in accessing effective pain treatment options.
© Medtronic, Inc. 2008

65. Interventional Pain Specialist Pain Management Approach
Recognizes unique benefits of technological advances and interventions
Communicates with all concerned parties to ensure best treatment possible
Develops follow-up plan once pain successfully treated
Collaborates with referring physician when treatment overlaps with general health care
Follows up with referring physician once pain is controlled
[Speaker should discuss his/her approach to managing pain patients after referral.]
© Medtronic, Inc. 2008

66. Interventional Pain Specialist Key Questions
What types of pain are treated?
How are services offered?
Which treatments are offered?
What type of follow-up is offered?
Does the pain specialist:
Provide 24/7 coverage?
Have privileges at your admitting hospital?
Provide inpatient coverage for hospitalized patients?
Pain facilities can vary greatly in their staff makeup, size, philosophy and treatment approach.
One way to distinguish between the different types of pain programs is to ask these questions.
© Medtronic, Inc. 2008

67. Interventional Pain Specialist Referral Criteria
Multiple symptoms or pain sources
Conservative therapies not working
Patient’s functional status deteriorated
Uncomfortable prescribing or monitoring opioids
It is important to understand the need to refer a chronic pain patient early in the process.
Patients often are referred to a pain clinic after too many ineffective therapies have been applied and failed.
Early referral will allow the pain specialist to provide a comprehensive formulation of the problem and a quick reversal of the situation when possible.
Being able to identify circumstances under which a subspecialty referral is needed is key to ensuring a patient gets the right treatment.
© Medtronic, Inc. 2008

68. Device Therapy Referral Interventional Pain Specialist Role
Conduct a thorough patient history and physical exam
Develop an interventional pain treatment plan
Conduct a Medtronic Pain Therapy trial
Perform the Medtronic Pain Therapy implantation or refer after the trial
Develop a follow-up plan with the patient
[Speak to the slide. Stress the collaborative relationship that should exist between the physicians.]
© Medtronic, Inc. 2008

69. Summary
With today’s treatments, patients should not have to wait for effective pain relief
By partnering, we can help patients find the right pain treatment
Together we can improve the quality of life for chronic pain patients
Our decisions may change the course of a patient’s life
Working as a team, we are able to treat all aspects that factor into the patients’ pain experience: health, injury, emotional, family, community and psychosocial.
Together we can improve the quality of life for chronic pain patients and our decisions may change the course of their lives.
© Medtronic, Inc. 2008

70. Case Study
© Medtronic, Inc. 2008

71. Case Study Male, 45, office manager, no major psychosocial issues
One spine surgery to treat herniated disc
Referred from primary care physician to address axial back pain and secondary radicular pain that persists six months following anatomically corrective surgery
Average back pain score (VAS) of 80/100 with diminished functional capacity
Relief from physical rehabilitation therapy was not satisfactory
Unsuccessfully treated with neuropathic pain agents and two systemic opioids, patient experienced extreme sedation and constipation
Treated with nerve block series but relief was temporary
Our final discussion point is the case study outlined above.
© Medtronic, Inc. 2008

72. SynchroMed® Infusion System Brief Summary
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:
When infection is present; when the pump cannot be implanted 2.5 cm or less from the surface of the skin; when body size is not sufficient to accept pump bulk and weight; when contraindications exist relating to the drug; drugs with preservatives. Do not use the Personal Therapy Manager accessory to administer opioid to opioid-naïve patients or to administer ziconotide.
Warnings:
Comply with all product instructions for initial preparation and filling, implantation, programming, refilling, and injecting into the catheter access port (CAP) of the pump. Failure to comply with all instructions can lead to technical errors or improper use of implanted infusion pumps and result in additional surgical procedures, a return of underlying symptoms, or a clinically significant or fatal drug under- or overdose. Refer to the appropriate drug labeling for specific under- or overdose symptoms and methods of management. Avoid using short wave (RF) diathermy within 30 cm of the pump or catheter. Diathermy may produce significant temperature rises in the area of the pump and continue to heat the tissue in a localized area. If overheated, the pump may over infuse the drug, potentially causing a drug overdose. Effects of other types of diathermy (microwave, ultrasonic, etc.) on the pump are unknown. 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. For intraspinal therapy, use only preservative-free sterile solution indicated for intraspinal use. Use only Medtronic components indicated for use with this system. Failure to firmly secure connections can allow drug or cerebrospinal fluid (CSF) leakage into tissue and result in tissue damage or inadequate therapy. A postoperative priming bolus should not be programmed if the pump is a replacement and the catheter has not been aspirated.
© Medtronic, Inc. 2008

73. SynchroMed® Infusion System Brief Summary continued
Refer to appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration information, and screening procedures. Physicians must be familiar with the drug stability information in the technical manual 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. 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. Instruct patients to notify their clinician of travel plans, to return for refills at prescribed times, avoid activities such as strenuous exercise or contact sports that jar, impact, twist, or stretch the body, to always carry their Medtronic device identification card, to avoid manipulating the pump through the skin, and to notify healthcare professionals of the implanted pump before medical tests/procedures. Patients must consult their physician before engaging in activities involving pressure or temperature changes (e.g., scuba diving, saunas, hot tubs, hyperbaric chambers, flights, skydiving, etc.) Inform patients that pump has an Elective Replacement Indicator (ERI) that sounds when the pump is nearing its end of service. When the alarm sounds, patients must contact their doctor to schedule pump replacement.
Precautions:The pump is ethylene oxide sterilized. Do not use if the product or package is damaged, the sterile seal is broken, or the “Use By” date has expired. Do not reuse or resterilize the pump; it is intended for “single use only.” Do not expose the pump to temperatures above 43°C or below 5°C. Consider use of peri- and post-operative antibiotics for pump implantation, for any subsequent surgical procedure, or if infection is present. For patients prone to CSF leaks, clinicians should consider special procedures, such as a blood patch. Follow instructions for emptying and filling the pump during a replacement or revisions that require removal of the pump from the pocket. Explant the pump postmortem if incineration is planned (to avoid explosion), or if local environmental regulations mandate removal. Return explanted devices to Medtronic for analysis and safe disposal. Do not implant a pump dropped onto a hard surface or showing signs of damage. Implant the pump less than 2.5 cm from the surface of the skin. Ensure pump ports will be easy to access after implant, that the catheter is not kinked and secured well away from pump ports before suturing. Keep the implant site clean, dry, and protected from pressure or irritation. If therapy is discontinued for an extended period of time, fill the reservoir with preservative-free saline in intraspinal applications or appropriate heparinized solution (if not contraindicated) in vascular applications. The magnetic field or telemetry signals produced by the programmer may cause sensing problems and inappropriate device responses with an implantable pacemaker and/or defibrillator. Electromagnetic interference (EMI) is an energy field generated by equipment found in the home, work, medical, or public environments. Most EMI normally encountered will not affect the operation of the pump. Exceptions include: injury resulting from heating of the pump which can damage surrounding tissue (diathermy, MRI), system damage which can require surgical replacement or result in loss/change in symptom control (defibrillation, electrocautery, high-output ultrasonics, radiation therapy), and operational changes to the pump causing the motor to stop, loss of therapy, return of underlying symptoms, and require confirmation of pump function (diathermy, high magnetic field devices, hyperbaric/hypobaric conditions, magnetic resonance imaging (MRI)). MRI will temporarily stop the pump motor’s rotor due to the magnetic field of the MRI scanner and suspend drug infusion during MRI exposure which will cause the pump alarm to sound. The pump should resume normal operation upon termination of MRI exposure. Prior to MRI, the physician should determine if the patient can safely be deprived of drug delivery. If not, alternative delivery methods for the drug can be utilized during the MRI scan. Prior to scheduling an MRI scan and upon its completion, pump status should be confirmed.
© Medtronic, Inc. 2008

74. SynchroMed® Infusion System Brief Summary continued
Adverse Events:
Include, but are not limited to, cessation of therapy due to end of device service life or component failure, change in flow performance due to component failure, inability to program the device due to programmer failure, CAP component failure; inaccessible refill port due to inverted pump, pocket seroma, hematoma, erosion, infection, post-lumbar puncture (spinal headache), CSF leak, radiculitis, arachnoiditis, bleeding, spinal cord damage, meningitis (intrathecal applications), anesthesia complications, damage to the pump, catheter and catheter access system due to improper handling and filling before, during, or after implantation; change in catheter performance due to catheter kinking, disconnection, leakage, breakage, occlusion, dislodgement, migration, or catheter fibrosis; body rejection phenomena, surgical replacement of pump or catheter due to complications; local and systemic drug toxicity and related side effects, complications due to use of unapproved drugs and/or not using drugs in accordance with drug labeling, or inflammatory mass at the tip of the catheter.
!USA Rx Only
© Medtronic, Inc. 2008

75. Neurostimulation Systems for Pain Therapy Disclosure
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. 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 Rx Only. November, 2007
© Medtronic, Inc. 2008

76. Thank You © Medtronic, Inc. 2008
Note that Medtronic offers the following physician resources :
Customer service
Reimbursement support
Medtronic PRACTICE Advantage®
Practice marketing tools
Training and education courses
Local Medtronic representative
And the following patient resources:
Patient brochures and videos
Patient Ambassador Program
Tame the Pain website
© Medtronic, Inc. 2008