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 System This is a picture of a trial system with 2 temporary leads. 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 multi-disciplinary 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?