advanced therapy for chronic pain relief: neurostimulation
TRANSCRIPT
Advanced Therapy for Chronic Pain Relief: Neurostimulation
Discussion
What brings you here today? What is neurostimulation? How can you know that it will
help your pain? What are the next steps?
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
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?
"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 .
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
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
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.
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 worker’s compensation programs
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.
“I felt my little toes for the first time in years, and I started crying. It was the most wonderful
sensation I’d 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 .
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
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
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
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.
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.
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
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
Patient Ambassador Program
Opportunity to connect with real patients who have ANS devices
Candidate can email or phone
Patient ambassadors are volunteers
“In a heartbeat. I highly recommend it.” “It’s something everybody can understand. It’s 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.
More Information
Talk to your ANS clinical representative
Go to PowerOverYourPain.com for more information
Contact a Patient Ambassador
Check your insurance coverage
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.”
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 .”
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).
User’s 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.
Questions?
Additional Information Regarding Neurostimulation
Components of a Trial System
Trial Lead
Trial Cable
Trial Transmitt
er
What is My Role During a Trial Screening?
Understand and comply with movement restrictions
Understand what sensations to expect
What Is My Role During a Trial Screening?
Document your response to treatment, pain level and functional changes (trial diary will be provided)
Follow physician’s recommendations on activity level
During the Trial: Do’s Follow you physician’s 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
During the Trial: Don’ts 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
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
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
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.”
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 .”
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).
User’s 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.
Thank you for your time!