This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. Indications For UseĪbbott Medical spinal cord stimulation (SCS) systems are indicated 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, nonsurgical back pain (without prior surgery and not a candidate for back surgery), and diabetic peripheral neuropathy of the lower extremities. 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. Spinal Column Stimulation (SCS) Systems Intended Use Microvascular decompression and radiofrequency for the treatment of trigeminal neuralgia: a meta-analysis. Radiofrequency denervation for treatment of sacroiliac joint pain-comparison of two different ablation techniques. Facet (Zygapophyseal) Intraarticular joint injections: cervical, lumbar, and thoracic. Cervical zygapophysial (facet) joint pain: effectiveness of interventional management strategies. Manchikanti L, Hirsch JA, Kaye AD, Boswell MV. A systematic review and best evidence synthesis of effectiveness of therapeutic facet joint interventions in managing chronic spinal pain. Manchikanti L, Kaye AD, Boswell MV, et al. Proclaim™ DRG Neurostimulation System Clinician’s Manual. Jude Medical’s Prodigy Chronic Pain System with Burst technology. De Ridder D, Vanneste S, Plazier M, Vancamp T. Eterna™ SCS IPG Size Comparison Memo (MAT-2210151) 2022.ħ. Burst spinal cord stimulation for limb and back pain. De Ridder D, Plazier M, Kamerling N, Menovsky T, Vanneste S. Success using neuromodulation with BURST (SUNBURST) study: results from a prospective, randomized controlled trial using a novel burst waveform. Abbott. Eterna™ SCS IPG Lowest Recharge Burden Comparison Memo (MAT-2210739) 2023.Ĥ. Abbott. Eterna™ SCS IPG Elect Design Verification Report: Current Draw (90860050). Eterna™ SCS IPG Battery Recharge Characterization Report (90903492) 2023.Ģ. Refer to the IFU for additional information. Safety comparisons and specific dose-response curves for each dosage have not been clinically established. NOTE: In neurostimulation therapy, ‘dose’ refers to the delivery of a quantity of energy to tissue. ** Up to 10 years of battery longevity at the lowest dose setting: 0.6mA, 500 Ohms, duty cycle 30s on/360s off. Refer to the Instructions for Use for full details on the MR Conditional scan parameters. ‖ Smallest size determined by volume in cubic centimeters. † BurstDR™ stimulation superiority when compared to traditional tonic stimulation as studied in SUNBURST. ![]() * Approximately three hours five times per year (69 to 74 days between charges) at standard (nominal) settings for BurstDR™ stimulation programs: 30/90 dosing when programmed with amplitude of 0.6mA and all other BurstDR™ stimulation settings are left at default.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |