Advanced Therapy for Chronic Pain Relief: Neurostimulation

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Advanced Therapy for Chronic Pain Relief
Neurostimulation
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Discussion

• What brings you here today?
• What is neurostimulation?
• How can you know that it will help your pain?
• What are the next steps?

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What Has Been Your Success with These Therapies?

• TENS
• NSAIDs
• Ibuprofen and Aspirin
• Pain Medications
• Biofeedback
• OTC Pain
• Rehabilitative Therapy
• Systemic Opioids
• Morphine
• Nerve Blocks

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How Would You Like Your Life to Improve?

• What activities do you want to be able to do ?
• How would you like your life to change?

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"Without this therapy, I would be in a
wheelchair. Instead, I'm fishing with my family.
-Luella Thomas, patient and ANS Ambassador
The above testimonial is the experience of this
individual only. It is an individual result and
we do not claim that it is representative of the
experience that all or most patients achieve and
is not indicative of future performance or
success .
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Your Physician Has Recommended Neurostimulation

• Most likely because
• You have had pain that has lasted more than 4-6
  months
• You have had limited pain relief from your
  current pain medications or pain therapies
• You have had multiple procedures that have not
  worked

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What Is Neurostimulation?

• Neurostimulation is also commonly known as spinal
  cord stimulation (SCS)
• A non-drug pain relief therapy that works by
  generating mild electrical pulses and sending
  them along your spinal cord to the brain
• It replaces the feeling of pain with a tingling
  or massaging sensation

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Established Therapy for Chronic Pain

• Neurostimulation is a widely accepted medical
  treatment.
• Similar technology to pacemakers.
• Each year as many as 50,000 neurostimulators are
  implanted worldwide.1

1Simpson BA. Electrical Stimulation and the
Relief of Pain. Boston, Mass Elsevier 2003.
Pain Research and Clinical Management, Vol. 15.
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Established Therapy for Chronic Pain

• FDA-approved therapy for treatment of chronic
  pain of the trunk and limbs
• Covered by most major health insurance plans,
  Medicare and workers compensation programs

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A Study of Chronic Pain Sufferers Who Used ANS
Neurostimulators¹

• 84 reported that their quality of life was
  improved or greatly improved
• 77 had good or excellent pain relief
• 82 decreased their use of pain medications

¹ Advanced Neuromodulation Systems. Prospective,
Multi-Centered, Single Arm Study to Evaluate the
Safety and Effectiveness of Genesis Implantable
Pulse Generator in Combination with ANS
Percutaneous Leads for the Management of Chronic
Pain of the Trunk and/or Limbs. Plano, Tex 2006.
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• I felt my little toes for the first time in
  years, and I started crying. It was the most
  wonderful sensation Id ever felt.
• -Deborah Sanders, patient since 2006 and ANS
  Ambassador

The above testimonial is the experience of this
individual only. It is an individual result and
we do not claim that it is representative of the
experience that all or most patients achieve and
is not indicative of future performance or
success .
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How will I Know if This Therapy will Reduce My
Pain?

• A trial period allows the patient to evaluate
  the effect of pain relief before deciding on this
  therapy in the long term

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The Trial (Screening) Period

• Has a unique advantage over other pain management
  therapies in that it can be removed at any time
• Typically 5-7 days

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What Can I Expect During a Trial?

• A minimally invasive outpatient procedure
• Similar to an epidural steroid injection
• One or more leads are placed in the space along
  the spinal cord

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What Can I Expect During a Trial?

• Patient is generally awake during the procedure
  so that they can provide feedback to the
  physician regarding exact placement.

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What Can I Expect During a Trial?

• The lead or leads connect to a system that can be
  worn on a belt. The system may contain a variety
  of programs to allow the patient to best evaluate
  the stimulation.

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What Are The Elements of a Successful Trial?

• Your pain is reduced to a manageable level so
  that you may return to a more normal lifestyle
• Many people consider spinal cord stimulation
  successful if
• It is easier for them to go places and do things
• It helps them sleep better
• It reduces their need for drugs

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If the Trial is Successful, What Happens Next ?

• You may wish to discuss delivery of this therapy
  with your physician
• Discuss what type of system is best for your pain
  needs and lifestyle
• Implanted device may be performed as an
  outpatient procedure
• Although called permanent, still reversible

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Patient Ambassador Program

• Opportunity to connect with real patients who
  have ANS devices
• Candidate can email or phone
• Patient ambassadors are volunteers

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In a heartbeat. I highly recommend it. Its
something everybody can understand. Its easier
to use than a remote control on a TV.-Ralph
Wright, patient and ANS Ambassador
The above testimonial is the experience of this
individual only. It is an individual result and
we do not claim that it is representative of the
experience that all or most patients achieve and
is not indicative of future performance or
success.
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More Information

• Talk to your ANS clinical representative
• Go to PowerOverYourPain.com for more information
• Contact a Patient Ambassador
• Check your insurance coverage

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Eon and Genesis SystemsIndicated Use Statement

• Aid in the management of chronic intractable
  pain of the trunk and/or limbs including
  unilateral or bilateral pain associated with any
  of the following failed back surgery syndrome,
  and intractable low back and leg pain.

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Renew RF SystemIndicated Use Statement

• Indicated for spinal cord stimulation in the
  treatment of chronic pain of the trunk and limbs
  either as a sole mitigating agent or as an
  adjunct to other modes of therapy used in a
  multidisciplinary approach .

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Product Safety Information

• Indications for Use Chronic, intractable pain of
  the trunk and limbs.
• Contraindications Demand-type cardiac
  pacemakers, patients who are unable to operate
  the system or who fail to receive effective pain
  relief during trial stimulation.
• Warnings/Precautions Diathermy therapy,
  cardioverter defibrillators, magnetic resonance
  imaging (MRI), explosive or flammable gases,
  theft detectors and metal screening devices, lead
  movement, operation of machinery and equipment,
  postural changes, pediatric use, pregnancy, and
  case damage. Patients who are poor surgical
  risks, with multiple illnesses, or with active
  general infections should not be implanted.
• Adverse Events Painful stimulation, loss of pain
  relief, surgical risks (e.g., paralysis).
• Users guide must be reviewed prior to use for
  detailed disclosure.
• Caution U.S. federal law restricts this device
  to sale and use by or on the order of a physician.

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• Questions?

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Additional Information Regarding Neurostimulation
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Components of a Trial System
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What is My Role During a Trial Screening?

• Understand and comply with movement restrictions
• Understand what sensations to expect

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What Is My Role During a Trial Screening?

• Document your response to treatment, pain level
  and functional changes (trial diary will be
  provided)
• Follow physicians recommendations on activity
  level

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During the Trial Dos

• Follow you physicians orders regarding
  activities and wound care
• Sleep on your back or side
• Keep your incision dry by taking sponge baths
• Keep a trial diary
• Call your physician immediately if you notice any
  signs of infection such as
• Fever
• Chills
• Redness
• Increased pain at the incision site

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During the Trial Donts

• Pull on the trial cable or lead
• Disconnect the trial cable from the lead
• Operate vehicles, machinery, or power equipment
  with the stimulator on
• Reach, bend, or stretch
• Lift more than five (5) pounds
• Climb many stairs
• Sleep on your stomach
• Engage in strenuous activity during the trial

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Implanted device

• Generator and leads placed within body
• Procedure time may be similar to a trial
  procedure
• Often performed on an outpatient basis or in a
  surgery center
• Reversible

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What are the Components of a Neurostimulator?

• Programmer
• "Remote control that lets you adjust the
  strength and/or location of stimulation
• Generator
• Holds the electronic components and sends the
  electrical current through the lead
• Leads
• Very thin cables that deliver electrical pulses
  to nerves along your spinal cord

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Eon and Genesis SystemsIndicated Use Statement

• Aid in the management of chronic intractable
  pain of the trunk and/or limbs including
  unilateral or bilateral pain associated with any
  of the following failed back surgery syndrome,
  and intractable low back and leg pain.

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Renew RF SystemIndicated Use Statement

• Indicated for spinal cord stimulation in the
  treatment of chronic pain of the trunk and limbs
  either as a sole mitigating agent or as an
  adjunct to other modes of therapy used in a
  multidisciplinary approach .

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Product Safety Information

• Indications for Use Chronic, intractable pain of
  the trunk and limbs.
• Contraindications Demand-type cardiac
  pacemakers, patients who are unable to operate
  the system or who fail to receive effective pain
  relief during trial stimulation.
• Warnings/Precautions Diathermy therapy,
  cardioverter defibrillators, magnetic resonance
  imaging (MRI), explosive or flammable gases,
  theft detectors and metal screening devices, lead
  movement, operation of machinery and equipment,
  postural changes, pediatric use, pregnancy, and
  case damage. Patients who are poor surgical
  risks, with multiple illnesses, or with active
  general infections should not be implanted.
• Adverse Events Painful stimulation, loss of pain
  relief, surgical risks (e.g., paralysis).
• Users guide must be reviewed prior to use for
  detailed disclosure.
• Caution U.S. federal law restricts this device
  to sale and use by or on the order of a physician.

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Thank you for your time!