Download Neurostimulation

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® Systems
Indicated 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 System
Indicated 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
Transmitter
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® Systems
Indicated 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 System
Indicated 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!