Dr. Timothy Lubenow and Dr. Jason Pope had too much to talk about when it comes to Radiofrequency - Listen now to Radiofrequency round 2 to continue the discussion on Radiofrequency in your practice.
IonicRF Generator Clinician’s Manual. Plano, TX. 2020.
MINT study (In the Lupe 10): Juch, Johan NS, et al. "Effect of radiofrequency denervation on pain intensity among patients with chronic low back pain: the mint randomized clinical trials." Jama 318.1 (2017): 68-81.
Pope mention of retrospective study (In the Lupe 11): Cheng, Jianguo, et al. "Comparative outcomes of cooled versus traditional radiofrequency ablation of the lateral branches for sacroiliac joint pain." The Clinical journal of pain 29.2 (2013): 132-137.
Rx OnlyBrief 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.
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.
Indications for Use:
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.
AbbottOne St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1 651 756 2000Neuromodulation.Abbott
™ Indicates a trademark of the Abbott group of companies.‡ Indicates a third party trademark, which is property of its respective owner.© 2021 Abbott. All Rights Reserved.
MAT-2012731| Item is approved for global use.