Help Patients Take Control of Chronic Pain

• [Insert Speaker Name]

• [Insert Practice Name and Location]

• [List Staff Members]

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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)

Topics

• Chronic Pain and Its Impact

• Chronic Pain Patient Evaluation

• Medtronic Pain Therapies

• Why Medtronic?

• Patient Selection for Medtronic Pain Therapies

• Additional Resources

Chronic Pain and Its Impact

Chronic pain affects

100 MILLIONAmerican adults*

Annually costs nation up to

$635 BILLIONin medical treatment and lost productivity*

*Institute of Medicine of the National Academies website. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. http:// www.iom.edu/Reports/2011/Relieving-Pain-in-America-A-Blueprint-for-Transforming- Prevention-Care-Education-Research.aspx. Accessed January 30, 2014.

How many chronic pain patients did you see last week?

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

Loeser JD, Melzack R. Pain: an overview. Lancet. 1999;353(9164):1607-9.

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?

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

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 carebegins with you

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

1. Prager J, Jacobs M. Evaluation of patients for implantable pain modalities: medical and behavioral assessment. Clin J Pain. 2001;17(3):206-214. 2. 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):504-515. 3. 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):463-469. 4. 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):735-742. 5. Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Electrical Nerve Stimulators (160.7). http://www.cms.gov/medicare-

coverage-database/details/ncd-details.aspx?NCDId=240&ncdver=1&DocID=160.7 &SearchType=Advanced&bc=IAAAABAAAAAA&. Accessed January 3, 2014. 6. Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Infusion Pumps (280.14). http://www.cms.gov/medicare-coverage-

database/ 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.

Medtronic Pain Therapies Target Site of Action

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.

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

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

Spinal Cord Stimulation

• Medtronic AdaptiveStim® delivers better pain relief

– 88.7%‡ of patients reported better pain reliefvs. conventional stimulation1,2

– Automatically adaptsto patient’s changingpostural therapy needs

– Maintains optimal therapyaround the clock

‡ 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.

1. Medtronic advanced pain therapy using neurostimulation for chronic pain. Clinical Summary, 2011. M221494A006.2. 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.

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

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

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

Targeted Drug Delivery

1. 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):1304-1313.

2. 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.

3. 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.

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

References provided on next slide.

Why Medtronic?

• References1. 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):98-107.

2. 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):179-188.

3. 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):4040-4049.

4. 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):393-406.

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):e003061.

6. 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):618-624.

7. 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.

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 3.0- Tesla MRI scans and

resume programmed therapy

after scan†

• You can’t predict the future, but

you can be ready for itMR 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.

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

* 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.

1. 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):762-770;discussion 770.

2. 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);363-373.

3. 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):98-107. 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;21:351-358.

4. 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):351-358.

5. 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):361-369.

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

* 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.

1. 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):4040-4049.

2. 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):393-406.

3. 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):e003061.

4. 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.

5. 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):1304-1313.

6. 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):1010-1016.

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.

5

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.

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?

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

*Medtronic Inc. Foundational Message Development for Patients Suffering from Chronic Pain. Qualitative Market Report. Oct. 2013.

“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

Medtronic Tools and Resources

professional.medtronic.com

Clinician Support

• Targeted Drug Delivery: professional.medtronic.com/tdd

Clinician Support

• Spinal Cord Stimulation: adaptivestim.com

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

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

Patient Supporttamethepain.com

What Questions Do You Have?

Thank You

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 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.  USA Rx Only Rev 0313

SynchroMed® II Drug Infusion SystemBrief SummaryProduct 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.

SynchroMed® II Drug Infusion SystemBrief 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.

SynchroMed® II Drug Infusion SystemBrief 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.

SynchroMed® II Drug Infusion SystemBrief 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