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Medtronic Pain Therapies Referral Strategies for Managing Chronic Pain

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

29 Patient Selection © Medtronic, Inc. 2008

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

58 SynchroMed® Infusion System Brief Summary
Indications: US: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, and chronic intrathecal infusion of Lioresal® Intrathecal (baclofen injection) for the management of severe spasticity; chronic intravascular infusion of floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer. Outside of US: Chronic infusion of drugs or fluids tested as compatible and listed in the product labeling. Contraindications: When infection is present; when the pump cannot be implanted 2.5 cm or less from the surface of the skin; when body size is not sufficient to accept pump bulk and weight; when contraindications exist relating to the drug; drugs with preservatives. Do not use the Personal Therapy Manager accessory to administer opioid to opioid-naïve patients or to administer ziconotide. Warnings: Comply with all product instructions for initial preparation and filling, implantation, programming, refilling, and injecting into the catheter access port (CAP) of the pump. Failure to comply with all instructions can lead to technical errors or improper use of implanted infusion pumps and result in additional surgical procedures, a return of underlying symptoms, or a clinically significant or fatal drug under- or overdose. Refer to the appropriate drug labeling for specific under- or overdose symptoms and methods of management. Avoid using short wave (RF) diathermy within 30 cm of the pump or catheter. Diathermy may produce significant temperature rises in the area of the pump and continue to heat the tissue in a localized area. If overheated, the pump may over infuse the drug, potentially causing a drug overdose. Effects of other types of diathermy (microwave, ultrasonic, etc.) on the pump are unknown. An inflammatory mass that can result in serious neurological impairment, including paralysis, may occur at the tip of the implanted catheter. Clinicians should monitor patients on intraspinal therapy carefully for any new neurological signs or symptoms. For intraspinal therapy, use only preservative-free sterile solution indicated for intraspinal use. Use only Medtronic components indicated for use with this system. Failure to firmly secure connections can allow drug or cerebrospinal fluid (CSF) leakage into tissue and result in tissue damage or inadequate therapy. A postoperative priming bolus should not be programmed if the pump is a replacement and the catheter has not been aspirated. © Medtronic, Inc. 2008

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

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

61 Neurostimulation Systems for Pain Therapy Disclosure
Brief Summary: Product Technical Manuals and Programming Guides must be reviewed prior to use for detailed disclosure. Indication for Use - Chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain. Contraindications: Diathermy. Warnings: Defibrillation, diathermy, electrocautery, MRI, RF ablation, & therapeutic ultrasound can result in unexpected changes in stimulation, serious patient injury or death. Rupture/piercing of neurostimulator can result in severe burns. Electrical pulses from the neurostimulator may result in an inappropriate response of the cardiac device. Precautions: The safety and effectiveness of this therapy has not been established for: pediatric use, pregnancy, unborn fetus, or delivery. Follow programming guidelines & precautions in product manuals. Avoid activities that stress the implanted neurostimulation system. EMI, postural changes, & other activities may cause shocking/jolting. Adverse Events: Undesirable change in stimulation; hematoma, epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief, chest wall stimulation, & surgical risks. For full prescribing information, please call Medtronic at and/or consult Medtronic’s website at Rx Only. November, 2007 © Medtronic, Inc. 2008

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

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