2 [Insert Speaker Name]* [Insert Practice Name and Location] [List Staff Members][Insert Hospital/Practice Photo]<INSERT THIS LINE IF PHYSICIAN IS BEING COMPENSATED BY MEDTRONIC FOR THE PRESENTATION: *Dr. _________ is a paid consultant of Medtronic, Inc.>
3 Practice Overview [Insert Mission Statement] Example: We aim to improve quality of life and functionality through a collaborative, multidisciplinary pain management program[Insert Practice Structure Information]Example: Clinic, Multidisciplinary Practice, etc.[Insert Comprehensive Practice Treatment Examples]Examples: Interventional Procedures, Medication Management, Physical Therapy, Referral to Specialists (chiropractor, surgeon, psychiatrist, rheumatologist)Talk briefly about the practice.MissionStructureTreatment examplesReferrals required for patients to be seen there?Importance of the referring healthcare providerEducationBuilding relationships to optimize patient care
4 Topics Chronic Pain and Its Impact Chronic Pain Patient Evaluation Medtronic Pain TherapiesClinical EvidenceSureScan® MRI TechnologyPatient Selection for Medtronic Pain TherapiesAdditional ResourcesThe topics covered today include …
5 Chronic Pain and Its Impact Chronic pain affects100 MILLIONAmerican adults*Annually costs nation up to$635 BILLIONin medical treatment and lost productivity*How many chronic pain patients did you see last week?Chronic pain impacts your patients AND your practice.Chronic pain affects 100 million American adults and annually costs the nation up to $635 billion in medical treatment and lost productivity.* Treatment of chronic low back pain alone represents an approximate $25 billion annual cost in the United States.1Opioid prescriptions continue to skyrocket with no corresponding improvements in the treatment of pain.2Chronic pain can be associated with depression, affect physical function, and impair quality of life for your patients.3-6*Institute of Medicine of the National Academies website. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Prevention-Care-Education-Research.aspx. Accessed January 21, 2014.Barolat G, Sharan A. Ong J. Spinal cord stimulation for back pain. In: Simpson BA (ed). Electrical Stimulation and the Relief of Pain Research and Clinical Management Vol 15. Burlington, Mass: Elsevier Science:Johns Hopkins Bloomberg School of Public Health. News Release, September 16, As opioid use soars, no evidence of improved treatment of pain. Accessed August 8, 2014.Bair MJ, Robinson RL, Katon W, Kroenke K. Depression and pain comorbidity: a literature review. Arch Intern Med. 2003;163(20):Turner JA, Franklin G, Heagerty PJ, et al. The association between pain and disability. Pain. 2004;112(3):307–314.Cummins J, Lurie JD, Tosteson TD, et al. Descriptive epidemiology and prior healthcare utilization of patients in the spine patient outcomes research trial’s (SPORT) three observational cohorts. Spine. 2006;31(7):806–814.Stewart WF, Ricci JA, Chee E, Morganstein D, Lipton R. Lost productive time and cost due to common pain conditions in the U.S. workforce. JAMA. 2003;290(18):*Institute of Medicine of the National Academies website. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. . Accessed July 21, 2014.
6 What Is Chronic Pain?Persistent pain that adversely affects well-being, level of function, and quality of lifeMay be caused by injury, infection, or ongoing conditionStress, environmental, and affective factors may contributeContinues when treatment stopsTypesNeuropathic: Results from damage or inflammation to nerves or nerve fibersNociceptive Pain: Typically arises from somatic and/or visceral structuresSome ExamplesFailed Back Syndrome, Spinal Stenosis, Radicular Pain Syndrome, Complex Regional Pain Syndrome, Cancer Pain, Compression Fractures from OsteoporosisThe International Association for the Study of Pain (IASP) defines chronic pain as “pain which persists past the normal time of healing.”1 Chronic pain can be of non-malignant origin (e.g., severe intractable pain in patients with long life expectancy), or of malignant origin (e.g., severe and progressive pain in cancer patients with limited life expectancy). With nonmalignant pain, three months is the most convenient point of division between acute and chronic pain. Those who treat cancer pain find that three months is sometimes too long to wait before regarding pain as chronic. The management of chronic pain remains a challenge due to multiple etiologies, complex clinical manifestations, plus the combination of sensory and emotional factors that constitute chronic pain.Types of chronic painNeuropathic:- Occurs as a consequence of damage to, or dysfunction of, the peripheral or central nervous system.- Described as shooting or shock-like with severe burning or aching sensations. Neuropathic pain may also produce numbness along the path of the affected nerve(s).- Examples of conditions associated with neuropathic pain include spinal nerve injury or radiculopathy, carpal tunnel syndrome, diabetic neuropathy, and post-herpetic neuralgia.Nociceptive:-Occurs when nociceptors are stimulated to transmit pain messages in response to injury or disease. In chronic pain, the nociceptors may still send pain messages long after the original injury has healed.-Described as a dull, sharp, aching, or throbbing pain.- Examples of conditions associated with nociceptive pain include cancer pain, bone pain (e.g., due to vertebral compression fractures), arthritis pain, and mechanical low back pain.Mixed pain state:- Complex condition with neuropathic and nociceptive features. Chronic, mixed pain is caused by an initial nervous system injury or dysfunction that produces secondary effects.-Low back pain, for example, may result from a mechanical injury that triggers chronic nociceptive pain. Later, that same injury may lead to nerve compression, resulting in chronic neuropathic pain. Other examples of conditions often associated with mixed pain include Complex Regional Pain Syndrome (CRPS), Failed Back Surgery Syndrome (FBSS), and some types of cancer pain.Task Force on Taxonomy of the International Association for the Study of Pain. In: Merskey H, Borgduk N, eds. Classification of Chronic Pain: Descriptions of Chronic Pain Syndromes and Definitions of Pain Terms. Merskey H, Borgduk N, eds. 2nd Edition. Seattle, WA: IASP Press; 1994 (reprinted 2002; updated 2011):Introduction page xi. Accessed July 21, 2014.Task Force on Taxonomy of the International Association for the Study of Pain. In: Merskey H, Borgduk N, eds. Classification of Chronic Pain: Descriptions of Chronic Pain Syndromes and Definitions of Pain Terms. Merskey H, Borgduk N, eds. 2nd Edition. Seattle, WA: IASP Press; 1994 (reprinted 2002; updated 2011):Introduction page xi. Accessed July 21, 2014.Loeser JD, Melzack R. Pain: an overview. Lancet 1999;353(916):
7 Chronic Pain Patient Evaluation Typical questionsIs pain acute or chronic?Is it axial, peripheral?Is there a radicular component?What functional limitations are present?Are there other associated symptoms (e.g., weakness, spasticity, bowel/bladder)?Has patient responded to conventional treatments?Has patient experienced complications or side effects from conventional treatments?Typical questions we consider when evaluating a chronic pain patient include …
8 Chronic Pain Patient Evaluation HistoryPain duration, onset, location, characterAssociated 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 ExamRule out urgent processesIdentify potential pain sourcesDetermine if there is psychiatric or emotional involvedThe patient’s history is important, also.And, of course then we conduct the physical exam.
9 Chronic Pain Patient Evaluation Discussion of optionsPatient preferences and goalsFunctional role at home or in workplaceMedical co-morbiditiesFamily and work historyEconomicsIndicated therapiesMultidisciplinary effortCollaborative approach to patient care begins with youHighlight information from the slide.
10 Medtronic Pain Therapies These therapies may be:Effective alternatives when conventional therapies and systemic pain medications provide inadequate pain relief or intolerable side effectsReasonable alternatives to consider before performing irreversible, neurodestructive surgical procedures1Cost-effective interventions2-4 generally covered and paid for by payers nationwide5-6Prager J, Jacobs M. Evaluation of patients for implantable pain modalities: medical and behavioral assessment. Clin J Pain. 2001;17(3):Guillemette S, Witzke S, Leier J, Hinnenthal J, Prager JP. Medical cost impact of intrathecal drug delivery for noncancer pain. Pain Med. 2013;14(4):Taylor RS, Ryan J, O’Donnell R, Eldabe S, Kumar K, North RB. The cost-effectiveness of spinal cord stimulation in the treatment of failed back surgery syndrome. Clin J Pain. 2010;26(6):Kemler MA, Raphael JH, Bentley A, Taylor RS. The cost-effectiveness of spinal cord stimulation for complex regional pain syndrome. Value Health. 2010;13(6):Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Electrical Nerve Stimulators (160.7). &SearchType=Advanced&bc=IAAAABAAAAAA&. Accessed January 3, 2014.Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Infusion Pumps (280.14). details/ncd-details.aspx?NCDId=223&ncdver=2&bc=AgAAQAAAAAAAAA%3d% 3d&. Accessed January 3, 2014.* Please refer to the Neurostimulation Systems for Pain Therapy Brief Summary and the SynchroMed® II Drug Infusion System Brief Summary at the end of this presentation for important risk and safety information.The next slides take a closer look at Medtronic Pain Therapy options and talk more about the specialist’s treatment plans.We’re all familiar with common treatment options, which may include NSAIDS, over-the- counter drugs, complementary medicine, long-term oral opioids, etc., and we know that multiple or simultaneous treatments are possible. Medtronic Pain Therapies may help provide patients with effective alternatives when conventional therapies and systemic pain medications provide inadequate pain relief or intolerable side effects.Medtronic Pain Therapies also can be reasonable alternatives to consider before performing irreversible, neurodestructive surgical procedures.In addition, they may provide patients with cost effective interventions—generally covered and paid for by payers nationwide.Prager J, Jacobs M. Evaluation of patients for implantable pain modalities: medical and behavioral assessment. Clin J Pain. 2001;17(3):Guillemette S, Witzke S, Leier J, Hinnenthal J, Prager JP. Medical cost impact of intrathecal drug delivery for noncancer pain. Pain Med. 2013;14(4):Taylor RS, Ryan J, O’Donnell R, Eldabe S, Kumar K, North RB. The cost-effectiveness of spinal cord stimulation in the treatment of failed back surgery syndrome. Clin J Pain. 2010;26(6):Kemler MA, Raphael JH, Bentley A, Taylor RS. The cost-effectiveness of spinal cord stimulation for complex regional pain syndrome. Value Health. 2010;13(6):Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Electrical Nerve Stimulators (160.7). &SearchType=Advanced&bc=IAAAABAAAAAA&. Accessed January 3, 2014.Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Infusion Pumps (280.14). details/ncd-details.aspx?NCDId=223&ncdver=2&bc=AgAAQAAAAAAAAA%3d% 3d&. Accessed January 3, 2014.
11 Medtronic Pain Therapies Target Site of Action Systemic Delivery of MedicationsTargeted Therapy Where it MattersWhen considering Medtronic Pain Therapies, it’s important to note the difference between systemic delivery vs. targeted therapy.In systemic delivery, oral and transdermal medications must be absorbed systemically and cross the “blood-brain barrier” to reach pain signals.With Medtronic Pain Therapies, the treatment is targeted to the site of action.Let’s discuss further what Medtronic pain therapies involve, including trial, implant, and features of the devices.Please refer to the Neurostimulation Systems for Pain Therapy Brief Summary and the SynchroMed® II Drug Infusion System Brief Summary at the end of this presentation for important risk and safety information.
12 What is Spinal Cord Stimulation? Treatment targeted to the site of actionAn implantable spinal cord stimulator delivers small electrical signals through a lead implanted in the epidural spacePatients feel a tingling sensation from the neurostimulation—instead of pain— in areas where the pain was feltIn contrast, oral and transdermal pain medications must be absorbed systemically and cross the “blood-brain barrier” to reach pain signals
13 Spinal Cord Stimulation TrialPatients can trial the therapyTemporary systemOnly component implanted is leadPatient uses system 3-10 daysSuccessful trial can be followed by implantImplantation of neurostimulator, lead(s), and extensions(s) if trial effectiveA spinal cord stimulation system implant is typically completed in 2 stages – trial and implant.Trial PurposeAssess efficacy of neurostimulation for pain managementAllow the physician to assess pain relief and functional improvementSufficient pain reliefIncreased functioningDecreased use of systemic analgesicsAllow the physician to select a neurostimulator based onoptimal stimulation parameter settingsenergy requirements/battery longevityEvaluation Trial ResultsMeasurement toolsTrial log (entries should show pain level scores that are consistently lower than pretrial scores)Data gathered by screening system (parameters settings used)Monitor medicationsAssess results against pre-trial goals establishedTrial outcome is positive when goals are metGeneral ImplantProduct verifiedPatient positioned and preppedLead(s) implantedNeurostimulator pocket createdLead or extension tunneled subcutaneouslyLead or extension connected to neurostimulatorNeurostimulator implanted
14 Spinal Cord Stimulation Medtronic AdaptiveStim® delivers better pain relief88.7%‡ of patients reported better pain relief vs. conventional stimulation1,2Automatically delivers personalized, responsive, round-the-clock reliefAutomatically adjusts stimulation based on the patient’s needs and preferences in different positionsAutomatically collects objective patient activity data to support clinical decisionsDistinguishing characteristic of Medtronic spinal cord stimulation—AdaptiveStimAs effective as neurostimulation systems are in helping manage pain, many patients experience uncomfortable stimulation when changing positions.To sustain comfort during these changes, patients frequently need to manually adjust stimulation when they change positions.Until recently this problem has not been addressed by currently available technology.Medtronic solved the problem of positional stimulation with AdaptiveStim® exclusively available with RestoreSensor.®It is the first and only neurostimulator to automatically adapt stimulation amplitude body position.It gives patients the opportunity for automatic adjustment of stimulation to fit their varying activities.AdaptiveStim:listens and senses when your patient changes position.learns from previous experience and remembers your patients’ last comfortable setting.responds by automatically adjusting to your patients’ optimal settings in each position.records to provide you with objective functional data.‡RestoreSensor® Clinical Study compared AdaptiveStim to Medtronic conventional stimulation; 88.7% is based on analysis of one of two questions that comprised the primary endpoint of improved convenience and/or better pain relief. Percentage based on respondents who completed the pain relief question.Medtronic advanced pain therapy using neurostimulation for chronic pain. Clinical Summary, M221494A006.Schultz D, Webster L, Kosek P, Dar U, Tan Y, Sun M. Sensor-driven position-adaptive spinal cord stimulation for chronic pain. Pain Physician. 2012;15(1):1-12.* Please refer to the Neurostimulation Systems for Pain Therapy Brief Summary at the end of this presentation for important risk and safety information.
15 What is Targeted Drug Delivery? An alternate route of delivering pain medicationsAn implantable infusion system delivers pain medication to the site of action, the cerebrospinal fluid and spinal cord, to directly affect pain pathwaysPhysician programs dosing and delivery parametersmyPTM® (an optional device) allows patients to self- administer boluses of morphine to manage unpredictable pain within physician-prescribed limitsIn contrast, oral and transdermal pain medications must be absorbed systemically and cross the “blood-brain barrier” to reach pain signals
16 Systemic vs. Targeted Delivery of Medications Systemic DosingDistributes drug via blood streamHigh blood levels of drugBrain receives highest proportion of drugHigh dose of drug required (high elimination load)Increase in systemic side effectsTargeted Drug DeliveryIntrathecal drug distributionLow blood levels of drugMost drug binds to TARGET (spinal cord pain receptors)Low dose of drug is effective (low elimination load)Reduced systemic side effects on brain and gutWith systemic dosing, whether it is oral, transdermal, or another route of systemic delivery, the drug is distributed via the blood stream. Systemic delivery results in high blood levels of the drug, with the brain receiving the highest proportion. Due to a high elimination load, high doses of the drug are required, which may result in increased systemic side effects.Targeted drug delivery targets the delivery of the drug intrathecally, directly into the cerebral spinal fluid in the spinal column. Targeted drug delivery results in low blood levels of the drug. Since most of the drug binds to the target or spinal cord pain receptors, a low dose of the drug can be effective, resulting in a low elimination load and reduced systemic effects on the gut and brain.Ruan X. Drug-related side effects of long-term intrathecal morphine therapy. Pain Physician. 2007;10:
17 Targeted Drug Delivery TrialPatients can trial the therapyBolus or in-dwelling catheterAssess for improvements in:Pain scoresPhysical functionSide effectsSuccessful trial can be followed by implantImplantImplantation of infusion pump and intrathecal cathetermyPTM® is optional for appropriate patientsDrug Trial PurposeAssess efficacy of drug administration for pain managementAllow physician to assess potential of achieving goals set during patient selection, such as sufficient pain relief (for cancer patients, may be only goal assessed), increased functioning, reduced side effects from systemic analgesics, decreased use of systemic analgesicsEvaluating Trial ResultsMeasurement tools can be subjective (pain diary, pain scores) and/or objective (monitor activities, monitor medications)Assess results against pre-trial goals establishedTrial outcome is positive when goals are metRisks During TrialComplications can occur with the trial, including bleeding, infection, spinal headaches, damage to the spinal cord, and drug side effects. You should not undergo a trial if you have an active infection at the time of the test, have a body size too small to accommodate an implanted pump, or if you are allergic to the pain medication.General ImplantProduct verifiedPatient positioned and preppedNeedle placedCatheter insertedPump prepared and pump pocket createdCatheter tunneled subcutaneouslyCatheter connected to the pumpPump placed in pocket and sutured to fasciaPump programmed (if programmable pump)Risks of TherapyThis therapy is not for everyone. In addition to surgical risks, such as infection and drug related adverse events, pump or catheter problems can occur and may be life threatening, result in spinal cord injury, or require corrective surgery. To understand the benefits and risks of this therapy, please talk to your doctor. For additional safety information, please refer to the labeling provided with the device and the Important Safety Information at
18 Targeted Drug Delivery Distinguishing characteristics:Graphic #1 notesIt’s important to remember that Targeted Drug Delivery is not a therapy—it is a delivery system for a therapy. For pain, morphine or ziconotide is the therapy.Graphic #2 notesThe patient therapy manager or myPTM is an exclusive feature of the SynchroMed programmable infusion system.The patient controls activated bolus doses to address unpredictable pain when needed.Doses and delivery parameters remain within physician-set limits.Do not use myPTM to administer morphine to opioid-naive patients or to administer ziconotide.Graphic #3 notesMore than 1 billion patient-hours of drug delivery are provided by SynchroMed devices each year. (Medtronic data on file. Approximately 122,000 implanted devices x 8760 patient-hours per year.)Hamza M, Doleys D, Wells M, et al. Prospective study of 3-year follow-up of low-dose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. 2012;13(10):Ellis DJ, Dissanayake S, McGuire D, et al. Continuous intrathecal infusion of ziconotide for treatment of chronic malignant and nonmalignant pain over 12 months: a prospective, open-label study. Neuromodulation. 2008;11(1):40-49.Medtronic data on file. Approximately 122,000 implanted devices x 8760 patient-hours per year.* Please refer to the SynchroMed® II Drug Infusion System Brief Summary at the end of this presentation for important risk and safety information.
19 Clinical Evidence100% of published Randomized Controlled Trials concerning implanted spinal cord stimulation or intrathecal drug delivery systems for chronic pain used Medtronic products1-7Through clinical evidence leadership and unparalleled reimbursement advocacy, Medtronic helps you reduce or eliminate economic and reimbursement barriers:You practice evidence-based medicine. Take a look at the evidence.Randomized Controlled Trials are Level 1 evidence -- the top-level of scientific evidence.100% of evidence-based coverage policies use clinical study data to deny or approve therapy accessMedtronic provides the most Level 1 evidence documenting the effectiveness of spinal cord stimulation and targeted drug delivery1-7References provided on next slide.
20 Clinical Evidence References 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):North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery ;56(1):Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):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.Smith TJ, Staats PS, Deer T, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002;20(19):Rauck RL, Wallace MS, Leong MS, et al. A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain. J Pain Symptom Manage ;31(5):Raphael JH, Duarte RV, Southall JL, Nightingale P, Kitas GD. Randomised, double-blind controlled trial by dose reduction of implanted intrathecal morphine delivery in chronic non- cancer pain. BMJ Open. 2013;3(7):e
21 Spinal Cord Stimulation Evidence* Long-term pain relief1,2Improved quality of life1,2More effective than repeat surgery for persistent radicular pain after lumbosacral spine surgery3Successful pain disability reduction2More cost-effective than conventional medical management and reoperation4,5Kumar K, Taylor RS, Jacques L, et al. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery. 2008;63(4): ;discussion 770.Harke H, Gretenkort P, Ladleif HU, Rahman S. Spinal cord stimulation in sympathetically maintained complex regional pain syndrome type I with severe disability. A prospective clinical study. Eur J Pain. 2005:9(4);North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1):Taylor RJ, Taylor, RS. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effective analysis. Int J Technol Assess Health Care. 2005;21(3):North RB, Kidd D, Shipley J, Taylor RS. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost effectiveness and cost utility analysis based on a randomized, controlled trial. Neurosurgery. 2007;61(2):* Please refer to the Neurostimulation Systems for Pain Therapy Brief Summary at the end of this presentation for important risk and safety information.
22 Targeted Drug Delivery Evidence* Effective pain relief1-6Reduced or eliminated use of pain medication4-6Reduced side effects compared to oral pain medication1,5,7Improved ability to function, return to work, and participate in activities of daily living4,5,8,95Smith TJ, Staats PS, Deer T, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002;20(19):Rauck RL, Wallace MS, Leong MS, et al. A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain. J Pain Symptom Manage. 2006;31(5):Raphael JH, Duarte RV, Southall JL, Nightingale P, Kitas GD. Randomised, double-blind controlled trial by dose reduction of implanted intrathecal morphine delivery in chronic non-cancer pain. BMJ Open. 2013;3(7):eDeer T, Chapple I, Classen A, et al. Intrathecal drug delivery for treatment of chronic low back pain: report from the National Outcomes Registry for Low Back Pain. Pain Med. 2004;5(1):6-13.Hamza M, Doleys D, Wells M, et al. Prospective study of 3-year follow-up of low-dose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. 2012;13(10):Atli A, Theodore BR, Turk DC, Loeser JD. Intrathecal opioid therapy for chronic nonmalignant pain: a retrospective cohort study with 3-year follow-up. Pain Med. 2010;11(7):Ruan X. Drug-related side effects of long-term intrathecal morphine therapy. Pain Physician. 2007;10(2):Roberts LJ, Finch PM, Goucke CR, Price LM. Outcome of intrathecal opioids in chronic non-cancer pain. Eur J Pain. 2001;5(4):Winkelmüller M, Winkelmüller W. Long-term effects of continuous intrathecal opioid treatment in chronic pain of nonmalignant etiology. J Neurosurg. 1996;85(3):*Please refer to the SynchroMed® II Drug Infusion System Brief Summary at the end of this presentation for important risk and safety information.
23 RisksThe most frequently reported problems following the surgery to implant a neurostimulation system include infection, lead movement, pain at the implant site, loss of therapy effect, and therapy that did not meet the patient's expectations.Targeted Drug Delivery risks may include infection, spinal fluid leak, paralysis, 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 at the end of this presentation for additional risk and safety information.
24 SureScan® MRI Technology Medtronic makes safe access to MRI scans possible*†Only Medtronic pain neurostimulation systems provide safe access to 1.5- Tesla MRI scans on any part of body*Medtronic SynchroMed® infusion systems provide safe full-body access to and 3.0- Tesla MRI scans and resume programmed therapy after scan†This is important to consider when addressing patients’ future diagnostic needsMedtronic recently released its SureScan® MRI family of pain neurostimulators—the first and only SCS system FDA approved for conditionally safe MRI scans anywhere on the body.* While Medtronic and other companies have invested heavily to globally commercialize their MR Conditional cardiac pacemakers, Medtronic is the first to provide this exclusive technology to help you serve the chronic pain population.Q & A“What is the difference between MR Conditional and MR Safe?”MR Safe - an item that poses no known hazards in all MRI environments. Using the terminology, “MR Safe” items are non-conducting, non-metallic, and non-magnetic items such as a plastic Petri dish.1MR Conditional - an item that has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use.1“Are CT and other diagnostic imaging modalities sufficient to diagnose my patients’ conditions?”ACR guidelines are the gold standard for radiology – evidence-based guidelines have been created by industry experts to highlight conditions where MRI is the only preferred imaging modality for patients.24,500+ peer-reviewed papers from the past 40+ years were evaluated and imaging modalities were rated on a 9-grade scale, with 9 being the most appropriate alternative.3*Under specific conditions; requires SureScan® implantable neurostimulator and Vectris® leads. Refer to approved labeling for full list of conditions.American Society for Testing and Materials (ASTM) International, Designation: F , Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. ASTM International, West Conshohocken, PA.Expert Panel on MR Safety, Kanal, E, et al. ACR guidance document on MR safe practices: J Magn Reson Imaging. 2013;37(3):501–530. doi: /jmri Accessed November 8, 2013 (http://onlinelibrary.wiley.com/doi/ /jmri.24011/pdf).American College of Radiology. ACR Appropriateness Criteria® available at Accessed October 31, 2013.*Under specific conditions. Neurostimulation for pain requires SureScan® implantable neurostimulator and Vectris® leads. Refer to approved labeling for full list of conditions.†Targeted drug delivery for pain requires interrogation to confirm pump status. Refer to approved labeling for full list of conditions.
25 SureScan® MRI Technology Diagnostic Imaging: CT and MRIUse the right diagnostic tool for the right patient conditionMagnetic Resonance Imaging. Wikipedia. (Accessed May 30, 2013).American College of Radiology. ACR Appropriateness Criteria®. Available at Accessed August 8, 2014.
26 SureScan® MRI Technology MRI is increasingly becoming the standard of care …Know where to go for additional information:for complete MRI labelingMRI Center Finder: to help locate a nearby center that accepts a Medtronic MRI SureScan® systemIMV MRI 2012 Benchmark Report.Medtronic data on file.
27 How Do You Identify Appropriate Patients 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?The chart on the right gives some examples of chronic pain that has been treated with spinal cord stimulation and targeted drug delivery.
28 — Medtronic Targeted Drug Delivery patient Patient ExpectationsEstablish specific, measureable goalsEnsure patients have realistic expectations and ability to participate in a comprehensive treatment planDiscuss the importance of the trial“My expectation after the trial is that I knew it would work. Before the trial, I was very hesitant. The most important thing is the trial. The trial is the thing that tells you if it works or if it doesn’t.*”— Medtronic Targeted Drug Delivery patientGoal examplesPain control with reduction of oral medicationsReduction of side effectsImproved activities of daily living (ADLs) – Gardening, shopping, holding grandchildrenIncreased range of motion, ambulationReduced hospital or ER visitsReturn to workUltimate goal: improved quality of lifeSet expectationsVariety of healthcare professionals may collaborate/interact throughout treatment processPain management specialist role—advanced chronic pain treatment options, including Medtronic Pain TherapiesIf Medtronic Pain Therapy indicated, patients can “trial” device first—without implantation—helps determine effectivenessPoint out these patients in the graphic:*Medtronic Inc. Foundational Message Development for Patients Suffering from Chronic Pain. Qualitative Market Report. OctLinda B., Failed Back Surgery Syndrome, Neurostimulation, Implant Date 2012.Tanya B., Chronic back pain, 2010 RestoreSensor® Clinical Study Patient, using AdaptiveStim® exclusively available with RestoreSensor®, FDA approved 2011.Hank E., Failed Back Surgery Syndrome, Targeted Drug Delivery, Implant Date: 2009.
29 Medtronic Tools and Resources professional.medtronic.comMedtronic healthcare professionals website: professional.medtronic.com—provides information on Medtronic Pain Therapies, products, and more.
30 Targeted Drug Delivery: professional.medtronic.com/tdd Clinician SupportTargeted Drug Delivery: professional.medtronic.com/tddInformation on Targeted Drug Delivery, including Approaches to Targeted Drug Delivery videos can be accessed at: professional.medtronic.com/tdd
31 Spinal Cord Stimulation: professional.medtronic.com/scs Clinician SupportSpinal Cord Stimulation: professional.medtronic.com/scsInformation on Spinal Cord Stimulation, including an in-depth look at AdaptiveStim® can be accessed at: professional.medtronic.com/scs
32 Clinician SupportProduct Performance Report: professional.medtronic.com/performanceTraining and education courses for healthcare professionalsE-learningContact your Medtronic representative to take advantage of varied opportunitiesOnly Medtronic publishes an annual Neurostimulation and Intrathecal Drug Delivery Systems Product Performance Report that provides:device survival estimates of Medtronic’s commercially available implantable products.data on more than 27,000 implanted devices and 9,300 patients.Access the Product Performance Report at: professional.medtronic.com/performanceAlso, several training and education courses are available. Contact your Medtronic representative—and take advantage of the many opportunities for healthcare professionals.
33 Patient Support Patient brochures and posters Tame the Pain website: tamethepain.comPhysician Finder: tamethepain.comPatient Ambassador Program: tamethepain.com/painambassadorConverse with a Nurse Program: tamethepain.com/nurseMedtronic Living Well Program: medtroniclivingwell.comPatient videos: youtube.com/medtronicchronicpainJust to clarify …Patient Ambassador Program (tamethepain.com/painambassador) connects prospective patients with volunteers who are willing to share their personal experience with a Medtronic Pain Therapy.Converse with a Nurse Program (tamethepain.com/nurse) provides opportunity for patients considering Medtronic Pain Therapies or those already implanted to connect with a nurse expert. Unlike the patient ambassadors, who are volunteers, these nurses are compensated by Medtronic.
34 Patient Support tamethepain.com Just to clarify … Patient Ambassador Program (tamethepain.com/painambassador) connects prospective patients with volunteers who are willing to share their personal experience with a Medtronic Pain Therapy.Converse with a Nurse Program (tamethepain.com/nurse) provides opportunity for patients considering Medtronic Pain Therapies or those already implanted to connect with a nurse expert. Unlike the patient ambassadors, who are volunteers, these nurses are compensated by Medtronic.
36 Neurostimulation Systems for Pain Therapy Brief Summary Product Technical Manuals and Programming Guides must be reviewed prior to use for detailed disclosure.Indication for Use - Chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain. Contraindications: Diathermy. Warnings: Defibrillation, diathermy, electrocautery, MRI, RF ablation, & therapeutic ultrasound can result in unexpected changes in stimulation, serious patient injury or death. Rupture/piercing of neurostimulator can result in severe burns. Electrical pulses from the neurostimulator may result in an inappropriate response of the cardiac device. Precautions: The safety and effectiveness of this therapy has not been established for: pediatric use, pregnancy, unborn fetus, or delivery. Follow programming guidelines & precautions in product manuals. Avoid activities that stress the implanted neurostimulation system. EMI, postural changes, & other activities may cause shocking/jolting. Patients using a rechargeable neurostimulator should check for skin irritation or redness near the neurostimulator during or after recharging. Adverse Events: Undesirable change in stimulation; hematoma, epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief, chest wall stimulation, & surgical risks.For full prescribing information, please call Medtronic at and/or consult Medtronic’s website atUSA Rx Only Rev 0313
37 SynchroMed® II Drug Infusion System Brief Summary Product technical manuals and the appropriate drug labeling must be reviewed prior to use for detailed disclosure.Indications:US: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, and chronic intrathecal infusion of Lioresal® Intrathecal (baclofen injection) for the management of severe spasticity; chronic intravascular infusion of floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer. Outside of US: Chronic infusion of drugs or fluids tested as compatible and listed in the product labeling.Contraindications:Infection; implant depth greater than 2.5 cm below skin; insufficient body size; spinal anomalies; drugs with preservatives, drug contraindications, drug formulations with pH ≤3, use of catheter access port (CAP) kit for refills or of refill kit for catheter access, blood sampling through CAP in vascular applications, use of Personal Therapy Manager to administer opioid to opioid-naïve patients or to administer ziconotide.
38 SynchroMed® II Drug Infusion System Brief Summary Warnings:Non-indicated formulations may contain neurotoxic preservatives, antimicrobials, or antioxidants, or may be incompatible with and damage the system. Failure to comply with all product instructions, including use of drugs or fluids not indicated for use with system, or of questionable sterility or quality, or use of non-Medtronic components or inappropriate kits, can result in improper use, technical errors, increased risks to patient, tissue damage, damage to the system requiring revision or replacement, and/or change in therapy, and may result in additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug under- or overdose. Refer to appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration information, screening procedures and underdose and overdose symptoms and methods of management. Physicians must be familiar with the drug stability information in the product technical manuals and must understand the dose relationship to drug concentration and pump flow rate before prescribing pump infusion. Implantation and ongoing system management must be performed by individuals trained in the operation and handling of the infusion system. An inflammatory mass that can result in serious neurological impairment, including paralysis, may occur at the tip of the implanted catheter. Clinicians should monitor patients on intraspinal therapy carefully for any new neurological signs or symptoms, change in underlying symptoms, or need for rapid dose escalation.
39 SynchroMed® II Drug Infusion System Brief Summary Warnings:Inform patients of the signs and symptoms of drug under- or overdose, appropriate drug warnings and precautions regarding drug interactions, potential side effects, and signs and symptoms that require medical attention, including prodromal signs and symptoms of inflammatory mass. Failure to recognize signs and symptoms and seek appropriate medical intervention can result in serious injury or death. Instruct patients to notify their healthcare professionals of the implanted pump before medical tests/procedures, to return for refills at prescribed times, to carry their Medtronic device identification card, to avoid manipulating the pump through the skin, to consult with their clinician if the pump alarms and before traveling or engaging in activities that can stress the infusion system or involve pressure or temperature changes. Strong sources of electromagnetic interference (EMI), such as short wave (RF) diathermy and MRI, can negatively interact with the pump and cause heating of the implanted pump, system damage, or changes in pump operation or flow rate, that can result in patient injury from tissue heating, additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug underdose or overdose. Avoid using shortwave (RF) diathermy within 30 cm of the pump or catheter. Effects of other types of diathermy (microwave, ultrasonic, etc.) on the pump are unknown. Drug infusion is suspended during MRI; for patients who can not safely tolerate suspension, use alternative drug delivery method during MRI. Patients receiving intrathecal baclofen therapy are at higher risk for adverse events, as baclofen withdrawal can lead to a life threatening condition if not treated promptly and effectively. Confirm pump status before and after MRI. Reference product labeling for information on sources of EMI, effects on patient and system, and steps to reduce risks from EMI.
40 SynchroMed® II Drug Infusion System Brief Summary Precautions:Monitor patients after device or catheter replacement for signs of underdose/overdose. Infuse preservative-free (intraspinal) saline or, for vascular applications, infuse heparinized solutions therapy at minimum flow rate if therapy is discontinued for an extended period of time to avoid system damage. EMI may interfere with programmer telemetry during pump programming sessions. EMI from the SynchroMed programmer may interfere with other active implanted devices (e.g., pacemaker, defibrillator, neurostimulator).Adverse Events:Include, but are not limited to, spinal/vascular procedure risks; infection; bleeding; tissue damage, damage to the system or loss of, or change in, therapy that may result in additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug underdose or overdose, due to end of device service life, failure of the catheter, pump or other system component, pump inversion, technical/programming errors, or improper use, including use of non-indicated formulations and/or not using drugs or system in accordance with labeling; pocket seroma, hematoma, erosion, infection; post-lumbar puncture (spinal headache); CSF leak and rare central nervous system pressure-related problems; hygroma; radiculitis; arachnoiditis; spinal cord bleeding/damage; meningitis; neurological impairment (including paralysis) due to inflammatory mass; potential serious adverse effects from catheter fragments in intrathecal space, including potential to compromise antibiotic effectiveness for CSF infection; anesthesia complications; body rejection phenomena; local and systemic drug toxicity and related side effects; potential serious adverse effects from catheter placement in intravascular applications.Lioresal® is a registered trademark of Medtronic, Inc. USA Rx Only Rev 0911