![]() The system is intended to be used with leads and associated extensions that are compatible with the system. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. For specific indications, contraindications, instructions, warnings, precautions, and adverse effects about system components available in your country or region, see the approved clinician's manual for those components. Read this section to gather important prescription and safety information. User’s Guide must be reviewed for detailed disclosure.ĭorsal Root Ganglion Therapy (DRG) Therapy Prescription and Safety Information 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 or flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery and equipment, pediatric use, pregnancy, and case damage.Īdverse Effects: Painful stimulation, loss of pain relief, surgical risks (e.g., paralysis). International: Patients who are unable to operate the system, are poor surgical risks, are pregnant, or under the age of 18. US: Patients who are unable to operate the system, who are poor surgical risks, or who have failed to receive effective pain relief during trial stimulation. International: Management of chronic intractable pain. **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. *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. 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.** Prior to using these devices, please review the User’s Guide for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. Talk to your doctor to see if the Proclaim™ DRG Neurostimulator System may help you manage your pain. While DRG therapy has been proven successful in many patients, it may not be right for everyone. Isolated chronic pain in a lower part of the body, such as the foot, knee, hip or groin, following an injury or surgical procedure.Chronic pain that has lasted six months or more.IS DRG THERAPY RIGHT FOR YOU?ĭRG therapy may be an option if you have: Talk to your doctor to see if the Proclaim™ DRG Neurostimulator System may be the right choice for your lower limb pain. The implanted device is MRI Conditional ‡ for the head and extremitiesĭRG therapy has helped many people manage their pain, but it may not be right for everyone.As we continue to advance our technology, your device can be kept up to date easily and painlessly through wireless software updates.The long-lasting battery 2 doesn’t need to be recharged.With our Proclaim™ DRG Neurostimulator System, you can conveniently and discreetly adjust your own therapy using familiar Bluetooth ** wireless technology and Apple ** mobile digital devices.We designed our Proclaim™ DRG Neurostimulator System to provide better pain relief with less effort and attention: ![]() People felt an average of 81.4 percent less pain at 12 monthsĬOMFORTABLE AND CONVENIENT PAIN MANAGEMENT.A long-term clinical study showed that DRG stimulation provides In one study of DRG therapy 1:Ībbott developed DRG stimulation for people with focal chronic pain. 1 PROVEN TO PROVIDE MORE RELIEFĭRG therapy treats patients with neuropathic chronic pain associated with CRPS of the lower limbs. The Proclaim™ DRG Neurostimulator System treats chronic pain in the foot, knee, or groin in patients with Complex Regional Pain Syndrome (CRPS).
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