Join Drs. Jason Pope and Timothy Lubenow for a new episode of Abbott Virtual Scientific Forum Podcast In the Lupe: History of Radiofrequency. List to our esteemed faculty discuss the history and importance of utilizing Radiofrequency in your practice day to day.
- Cohen SP, Bhaskar A, Bhatia A, et al. Consensus practice guidelines on interventions for lumbar facet joint pain from a multispecialty, international working group. Reg Anesth Pain Med. 2020;45(6):424‐467. doi:10.1136/rapm-2019-101243
Brief Summary:
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. The system is intended to be used with leads and associated extensions that are compatible with the system.
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.
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.
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.
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.
Indications for Use: The NT2000iXTM generator is intended for lesioning neural tissue. The NT2000iXTM generator is intended to be used for pain management. The NT2000iXTM generator is to be used only with separately cleared/approved lesion/temperature probes (NeuroTherm radiofrequency probes and SPINECATHTM and ACUTHERMTM catheters). The NT2000iXTM generator is indicated for use in the peripheral nervous system.
Warnings/Precautions: Hazardous electrical output, electric shock hazard, explosion hazard, fire hazard, pooling hazard, ignition hazard, fuse replacement, risk of RF burns to patient, interference with active implants, interference with other equipment, probes. User’s Guide must be reviewed for detailed disclosure.
US: The IonicRF™ Generator, in combination with approved compatible electrodes and cannulae, is indicated as an aid in the management of pain in the nervous system. Examples include facet denervation, trigeminal rhizotomy, and related functional neurosurgical procedures.
International: The IonicRF™ Generator, in combination with approved compatible electrodes and cannulae, is indicated as an aid in the management of pain in the nervous system. Examples include, but are not limited to, facet denervation, rhizotomy, and related functional neurosurgical procedures.
Contraindications: The use of this device is contraindicated in patients with systemic infection or local infection in the area of the procedure.
Warnings/Precautions: Hazardous electrical output, electric shock hazard, equipment failure, explosion hazard, fire hazard, pooling hazard, ignition hazard, risk of RF burns and unintended stimulation, risk of RF burns to patient, interference with active implants, redirection of high-frequency currents, interference with other equipment, shortwave or microwave equipment, apparent low output or failure of equipment, risk of patient injury, proper device use, non-sterile, accessories, continuity monitoring, inspection, mechanical damage, electrode positioning, use of fluids, dispersive connections, cleaning the generator, emergency stop.
Adverse Effects: Damage to surrounding tissue through iatrogenic injury; nerve injury, including thermal injury, or puncture of the spinal cord or nerve roots, potentially resulting in radiculopathy, paresis, and paralysis; pain, pulmonary embolism, hemothorax or pneumothorax, infection, unintended puncture wound, including vascular puncture and dural tear, hemorrhage, and hematoma. User’s Guide must be reviewed for detailed disclosure.
Simplicity™ III Disposable Radiofrequency Electrode
PRESCRIPTION AND SAFETY INFORMATION
Read this section to gather important prescription and safety information.
The Abbott Medical Simplicity™ III Disposable Radiofrequency Electrode is intended for use in the treatment of chronic pain by the ablation of neural tissue.
The Simplicity III electrode is a disposable radiofrequency (RF) device consisting of three isolated electrodes along the shaft. Radiopaque markers are located between the distal and the middle electrodes, between the middle and the proximal electrodes, and below the proximal electrode. These radiopaque markers clearly show the separation of the three electrodes under X-ray. The Simplicity III electrode needs to be connected to an Abbott Medical RF generator using an Abbott Medical adapter cable.
Do not proceed unless all electrodes read body temperature when connected and inserted into the patient.
Stop if heat is felt at site of the grounding pad.
When the Simplicity III electrode is used to perform lesion procedures in the sacral region, always ensure that the electrode does not enter any of the sacral foramen and that the electrode does not proceed inferior to the inferior border of the sacrum.
Do not use the electrode if the package has been opened or damaged.
Ensure the most proximal contact on the electrode is not too close to the dermis to prevent skin burn.
Use of general anesthesia is not recommended during the procedure. It is advised to use local anesthesia or conscious sedation so patient interaction is possible.
The electrode should only be used by physicians trained in the use of the device.
The electrode is intended for single-use only. This device is not intended for bilateral use.
The electrode should only be used with an Abbott Medical RF generator.
During treatment with the Simplicity III electrode, the patient should continuously be monitored and evaluated for any unexpected symptoms.
Before starting any thermal treatment with the electrode, ensure no motor nerves are in the vicinity of the electrode.
Do not move the electrode while it is activated.
Do not use the electrode if any damage is observed.
Do not bend or reshape the electrode; this can cause permanent mechanical damage.
Use minimal force and torque when manipulating the electrode; the handle has been designed to release if too much torque is applied.
Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness, or death of the patient.
Reprocessing may compromise the structural integrity of the device and/or lead to device failure.
Cleaning, disinfection, and sterilization may compromise essential material and design characteristics, leading to device failure.
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‡ Indicates a third party trademark, which is property of its respective owner.
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MAT-2012132 v1.0| Item is approved for global use.
