Gemini IPG Battery and Device Recovery from 0V (90956693). A 2-center comparative study on tonic versus burst spinal cord stimulation: amount of responders and amount of pain suppression. De Ridder D, Lenders MW, De Vos CC, et al. Eterna SCS IPG Size Comparison Memo (MAT-2210151) 2022.ĥ. Eterna Lowest Recharge Burden Comparison Memo (MAT-2210739) 2022.Ĥ. Eterna IPG Elect Design Verification Report: Current Draw (90860050). Eterna IPG Battery Recharge Characterization Report (90903492) 2022.Ģ. See Eterna Lowest Recharge Burden Comparison Memo (MAT-2210739) for more details.ġ. §§§§ Relative to other rechargeable SCS systems, 262 hours is calculated by comparing Eterna’s estimate of approximately 12 hours of charging per year with the number of hours of expected charging per year for competitive rechargeable systems at standard (nominal) settings. §§§ Approximately one hour per month at standard (nominal) settings for BurstDR TM programs: 30/90 dosing when programmed with amplitude of 0.6mA and all other BurstDRTM settings are left at default. §§ Recommended recharge frequency and duration for competitor products described in their respective IFU or clinical study. § Approximately three hours five times per year at standard (nominal) settings for BurstDR™ programs: 30/90 dosing when programmed with amplitude of 0.6mA and all other BurstDR™ settings are left at default. **** The term dose/dosage is referred to as the delivery of a quantity of energy to neural tissue. 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, visit OR ** Available on eligible Apple ‡ mobile digital devices. * BurstDRTM stimulation superiority when compared to traditional tonic stimulation as studied in SUNBURST. ++ Smallest size determined by volume in cubic centimeters. + Based off comparison to volumetric measurement of the following IPGS: WaveWriter Alpha™ 16: 20.1 cc Medtronic Intellis™:13.9 cc Nevro Omnia™: 26 cc Saluda Evoke™: 33 cc †† Based on PGIC scores of moderately better improvement or higher. Be sure to talk to your doctor about the risks associated with the placement of a neurostimulation system. Complications such as infection, swelling, bruising and possibly the loss of strength in or use of an affected limb or muscle group (i.e., paralysis) are possible. Please note: The placement of the leads is a surgical procedure that exposes you to certain risks. If, at the end of the evaluation period, you and your doctor decide the Eterna™ SCS System is right for you, you can choose to have the system implanted. Improves your ability to perform daily activities Your pain management doctor will determine if you are a candidate for stimulation therapy with the Eterna™ SCS System, and may recommend a temporary evaluation.ĭuring the temporary evaluation, you can see whether the therapy: One of the advantages of the Eterna™ SCS System is that you can try it out to see how well it works for you before committing to an implanted system.
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