References

1. Proclaim™ DRG Neurostimulation System Clinician’s Manual. Plano, TX. 2018.

* Up to 10 years of battery longevity at the lowest dose setting: 0.6mA, 500 Ohms, duty cycle 30s on/360s off. NOTE: In neurostimulation therapy, “dose” refers to the delivery of a quantity of energy to tissue. Safety comparisons and specific dose-response curves for each dosage have not been clinically established. Refer to the IFU for additional information.Hassle-free means recharge-free.

** When compared to traditional tonic stimulation.

***at 22:25 Speakers are referring to causalgia, not peripheral causalgia, this is defined in the ISI, see below

Rx Only

DRG

Indications for Use:

US: Spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.**

*Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drug classes and continued their pharmacologic therapy during the clinical study.

**Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Nerve damage may result from traumatic or surgical nerve injury. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia).

International: Management of chronic intractable pain.

Contraindications:

US: Patients who are unable to operate the system, who are poor surgical risks. Patients who have failed to receive effective pain relief during trial stimulation.

International: Patients who are unable to operate the system, are poor surgical risks, are pregnant, or under the age of 18.

Warnings/Precautions: Diathermy therapy, implanted cardiac systems or other active implantable devices, magnetic resonance imaging (MRI), computed tomography (CT), electrosurgery devices, ultrasonic scanning equipment, therapeutic radiation, explosive and flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery, equipment and vehicles, pediatric use, pregnancy, and case damage.

Adverse Effects: Unpleasant sensations, changes in stimulation, stimulation in unwanted places, lead or implant migration, epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space, cerebrospinal fluid leakage, tissue damage or nerve damage, paralysis, weakness, clumsiness, numbness, sensory loss, or pain below the level of the implant, pain where needle was inserted or at the electrode site or at IPG site, seroma at implant site, headache, allergic or rejection response, battery failure and/or leakage. Clinician’s Manual must be reviewed for detailed disclosure.

SCS

Indications for Use:

Spinal cord stimulation as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain.

Contraindications:

Patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation.

Warnings/Precautions: Diathermy therapy, implanted cardiac systems or other active implanted devices, magnetic resonance imaging (MRI), electrosurgery, explosive and flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery, equipment and vehicles, 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 Effects: Unpleasant sensations, changes in stimulation, stimulation in unwanted places, lead or implant migration, epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space, cerebrospinal fluid leakage, paralysis, weakness, clumsiness, numbness, sensory loss, or pain below the level of the implant, pain at the electrode or IPG site, seroma at IPG site, allergic or rejection response, battery failure. Clinician’s Manual must be reviewed for detailed disclosure.

Abbott

™ Indicates a trademark of the Abbott group of companies.

MAT-2006182 v1.0 | Item approved for global use.