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

© Medtronic, Inc. 2008

1

Medtronic Pain Therapies

Referral Strategies forManaging Chronic Pain


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


3

Types of Pain


4

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

Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 361-374


5

• Mechanical low back pain– Discogenic pain– Joint pain

• Facet joint

• Sacroiliac joint

– Pseudoarthrosis– Osteoporosis– Musculoskeletal trauma

Types of Nociceptive Pain



6

• Failed Back Surgery Syndrome (FBSS)*• Idiopathic chronic pain syndrome• Cancer pain

*Also referred to as “post-surgical chronic back pain”

Combined Nociceptive and Neuropathic Pain



7

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


8

Device therapies are now considered earlier in the

treatment continuum

Stamatos JM, et al. Live Your Life Pain Free, October 2005. Based on the interventional pain management experience of Dr. John Stamatos

Pain Treatment Ladder


9

Introduction to Medtronic Neurostimulation


10

• 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

Neurostimulation Therapy


11

• 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

Benefits of Neurostimulation

Kumar K, Nath RK, Toth C. Deep Brain Stimulation for Intractable Pain: A 15-year experience. Neurosurgery. 1997


12

• 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

Neurostimulation Trial

Kumar K, et al. Neurosurgery. 2006;58:481-496


13

• 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

Some Risks of Neurostimulation

North R, Kidd D, Zahurak M, et al. Neurosurgery. 1993;32:384-395.

For complete list of risks/complications, refer to product package insert


14

Introduction to Medtronic Intrathecal Drug Delivery (IDD)


15

• 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) Therapy


16

• 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

Synchromed® II Drug Infusion System Indications

Lioresal® is a registered trademark of Novartis Pharmaceuticals, Inc.


17

Route of Administration Relative Potency (mg)*

Oral

Intravenous

Epidural

Intrathecal

300

100

20

1

*Relative approximations based on clinical observations

Lamer TJ: Mayo Clin Proc. May 1994;69(5):473-80.

Approximate Equivalent Daily Doses of Morphine


18

• 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

Benefits of IDD Therapy

Lamer TJ: Mayo Clin Proc. May 1994;69(5):473-80.; Paice JA, et al: J Pain Symptom Manage.1996;11(2):71-80.


19

• 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

IDD Trial


20

• 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

IDD Therapy Risks

For complete list of risks/complications, refer to product package insert

Onofrio BM, Yaksh TL. J Neurosurg 1990;72:200-209.; Winkelmueller M, Winkelmueller W. J Neurosurg 1996;85:458-467.; Paice JA, Penn RD, Shott S. J Pain Symptom Manage 1996;11(2):71-80.


21

Patient Selection


22

Indications for Neurostimulation and Intrathecal Drug Delivery Therapy

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


23

• 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

Patient Selection Considerations

Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 362.


24

Patient Selection Checklist

Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 362.

Refer Patient for a Pain Therapy Trial

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


25

Neurostimulation Clinical Evidence


26

• 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

Medtronic PROCESS Study

Kumar, et al. Pain 2007


27

Clinically Significant Leg Pain ReliefKey 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

Kumar, et al. Pain 2007; n = 100


28

Significant Improvement in Function

Key Findings: Significant improvement in function (Oswestry Disability Index) in SCS+CMM group over 24 months



29

Significant Improvement in Quality of Life

Kumar, et al. Pain 2007

Key Findings:

Significant improvement in SCS+CMM group in 7/8 domains of QoL (SF-36) over 24 months

Visual Analog Scale (VAS)


30

High Satisfaction


Key Findings:

Treatment satisfaction among patients continuing SCS+CMM at 24 months


31

Long-Term Pain Relief

Kumar, et al. Neurosurgery 2006

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%

61.3 59.3

0

25

50

75

100

Patients (%)

Pain

Relief (%

)

FBSS with unilateral limb pain FBSS with bilateral limb pain


32

Neurostimulation is Most Effective When Considered Early

Kumar K, et al. Neurosurg. 2006;58;481-496

85%78%

42%35%

10% 9%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

Time Until Intervention (Yrs)

<2 2-5 5-8 8-11 11-15 >15

Su

cces

s R

ate

(%)


33

More Effective than Repeat Surgery

North, et al. Neurosurgery 2005 ; n=45

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


34Van Buyten J-P, et al. Eur J Pain 2001;5:299-307; n=125 pain cases; P<0.01 for all activities

10-Year Experience: Neurostimulation Improves Quality of Life

Increased Independence

DailyActivities

LeisureTime

Social Activities

Ability to Relax

0%5%

10%15%20%25%30%35%40%45%50%

QoL Parameters

Imp

rovem

en

t %

27% 27% 30% 42% 44%


35

Intrathecal Drug Delivery Clinical Evidence


36

Back and Leg Pain Relief

Deer, et al. Pain Medicine 2004; n=136

Key Findings:

Numeric back pain ratings decreased >48%, and leg pain ratings decreased by 32% at 12-month follow up


37

Successful Disability Reduction


Key Findings:

Successful disability reduction was reported in 60% of patients at 6 months and in 66% at 12 months


38

Decreased Use of Pain Medications


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

88.2% of patients were taking systemic opioids at baseline


39

Overall Global Pain Relief

Roberts, et al., European Journal of Pain; n=88

Key Findings:

Overall pain relief of ≥50% was reported by 82% of patients (40 of 49)

Nu

mb

er

of

Pa

tie

nts

Global Pain Relief (%)


40

Clinical Evidence Risks

1. Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature reviewJ Neurosrug (Spine 3) 100:254-267, 2004; 2. Staats P. Complications of intrathecal therapy. Pain Medicine 2008; 9(S1):S102-S107

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.


41

Role of Interventional Pain Specialist


42

Practice Management Collaboration


43

Interventional Pain SpecialistPain 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


44

Interventional Pain Specialist Referral Criteria

• Multiple symptoms or pain sources• Conservative therapies not working• Patient’s functional status deteriorated• Uncomfortable prescribing or monitoring

opioids


45

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


46

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


47

Case StudyMale, 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


48

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.


49

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.


50

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


51

Neurostimulation Systems for Pain Therapy DisclosureBrief 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 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com. Rx Only. November, 2007


52

Thank You

Documents

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