![]() Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. 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. This neurostimulation system is 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 and intractable low back and leg pain. ![]() 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. Read this section to gather important prescription and safety information. Spinal Column Stimulation (SCS) Prescription And Safety Information Novel intermittent dosing burst paradigm in spinal cord stimulation. Jude Medical’s Prodigy chronic pain system with burst technology. De Ridder D, Vanneste S, Plazier M, Vancamp. MRI Procedure Information, Abbott Medical MR Conditional SCS and DRG Systems. Comparison of spinal cord stimulation waveforms for treating chronic low back pain: Systematic review and meta-analysis. Karri J, Orhurhu V, Wahezi S, Tang T, Deer T, Abd-Elsayed A. Success using neuromodulation with BURST (SUNBURST) study: results from a prospective, randomized controlled trial using a novel burst waveform. Eterna™ SCS IPG Size Comparison Memo (MAT-2210151). Pocket pain, does location matter: a single-centre retrospective study of patients implanted with a spinal cord stimulator. Baranidharan G, Bretherton B, Richert G, et al. Eterna™ SCS IPG Lowest Recharge Burden Comparison Memo (MAT-2210739). Eterna™ SCS IPG Battery Recharge Characterization Report. †† The term dose/dosage is referred to as the delivery of a quantity of energy to neural tissue.ġ. Not a head-to-head comparison of stimulation settings or clinical outcomes. Recommended recharge frequency and duration for competitor product described in their respective IFU or clinical studies, which may involve different patient populations and other variables. competitive rechargeable systems based on their range of typical settings (approximately 1 hour of charging per month at standard settings vs. ** This is calculated by comparing the expected charging for the Eterna™ SCS System vs. Refer to the Instructions for Use for full details on the MR Conditional scan parameters. For a list of personal Apple ‡ mobile digital devices compatible with Abbott’s Patient Controller app, click here. ‖ Available on eligible Apple ‡ mobile digital devices. § BurstDR™ stimulation is superior when compared to traditional tonic stimulation as studied in SUNBURST. Based off comparison to volumetric measurement of the following IPGs: Boston Scientific‡ WaveWriter Alpha‡ 16: 20.1 cc Medtronic‡ Intellis‡: 13.9 cc Nevro‡ Omnia‡: 26 cc Saluda‡ Evoke‡: 33 cc. ![]() † Smallest size determined by volume in cubic centimeters. Note: In promotional materials using only part of this claim, i.e.,“The Eterna™ SCS System with Xtend™ energy technology reduces charging frequency to five times per year.” You may remit the disclaimer beginning at “*Recommended…” * Upon implant of the Eterna™ SCS System, approximately 3 hours 5 times per year (69 to 74 days between charges) or 1 hour per month (25 to 27 days between charges) at standard (nominal) settings for BurstDR™ programming: 30/90 dosing when programmed with amplitude of 0.6mA and all other BurstDR™ stimulation settings are left at default. ‡ Indicates a third party trademark, which is property of its respective owner. ![]() TM Indicates a trademark of the Abbott group of companies. ![]()
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