Download chronic intractable pain of the trunk and/or limbs

Overview of
Neurostimulation
Agenda
• Topics
– What is Neurostimulation and what does it
feel like?
– What happens during the trial procedure?
– What happens during a permanent
procedure?
Is this Therapy Right for You?
• Your physician has recommended
neurostimulation for you.
• You may be a good candidate for this
advanced therapy if
– You have had pain that has lasted more than
4 months
– Current pain medications or other pain
therapies are providing you limited relief
– You are seeking a minimally invasive
procedure
What is Neurostimulation?
• A neurostimulator generates mild electrical
pulses and sends them to an area along
your spinal cord
• Electrical pulses replace the feeling of pain
with a tingling or massaging sensation
• Neurostimulation could be spinal cord
stimulation (SCS) or peripheral nerve
stimulation
What is Spinal Cord
Stimulation?
What is Involved?
• SCS – Trial (Screening)
• SCS – Permanent Implant
What are the Components of a
Neurostimulator?
• Leads
– Very thin cables that deliver
electrical pulses to nerves
along your spinal cord
• Generator
– Holds the electronic
components and sends the
electrical current through
the lead
• Programmer
– "Remote control” that lets
you adjust the strength
and/or location of
stimulation
ANS Family of Products
There is a Right Device
for a Particular Indication
Conventional IPGs
Rechargeable IPGs
Radio-frequency
Systems
ANS Lead Family
Why a Trial (Screening) Period?
• A trial allows you to test before permanent
implantation
– A unique advantage over other pain
management therapies
• Allows the pain management physician to
assess the appropriate SCS system for
each patient
Components of a Trial System
Trial Lead
Trial Cable
Trial
Transmitter
What Can I Expect During a Trial?
• During an outpatient procedure, one or more
leads in the space are placed over the spinal
cord.
• Patient is generally awake during the procedure
so that they can provide feedback to the
physician regarding exact placement.
• The lead connects to a system that can be worn
on a belt. The system will contain a variety of
programs.
The Trial Period
• Short term
– 3 to 5 days
• Long term
– 7 to 14 days
What is My Role During a
Trial Screening?
• Working knowledge of SCS trial screener
• Understand and comply with movement
restrictions
• Understand what sensations to expect
• Document your response to treatment,
pain level and functional changes (trial
diary will be provided)
• Should be active
Permanent Procedure
• Generator and leads
placed within body
• Similar in length
compared to trial
procedure
• Often performed on
an outpatient basis or
in a surgery center
• Reversible
A study of chronic pain sufferers
who used ANS neurostimulators1
revealed the following:
• 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.
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
“Spinal cord stimulation is indicated for the
treatment of chronic pain of the trunk and limbs,
either as the sole mitigating agent or an adjunct
to other modes of therapy used in a multidisciplinary approach.”
“Only certain models are indicated to stimulate
electrically peripheral nerves to relieve severe
intractable pain.”
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).
• Clinician’s manual 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!
Questions?