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Page 1 of Page 6 of 51 Page 1 of Statement of Need The Corporal Michael J. Crescenz VA Medical Center requires additional components for the Leksell stereotactic system specifically to enhance the capabilities for performing Deep Brain Stimulation (DBS) procedures at our facility. Background Deep Brain Stimulation (DBS) is a recognized treatment for various neurological conditions, including Parkinson s disease, essential tremor, and dystonia. The procedure involves implanting electrodes within certain areas of the brain to produce electrical impulses that regulate abnormal impulses or affect certain cells and chemicals within the brain. CMC VAMC uses the Leksell stereotactic system for precise navigation and targeting during these intricate procedures. While the existing system provides a solid foundation, certain components must always have back-ups to maintain the highest standards of care, improve outcome accuracy, and expand the procedural capabilities in line with modern advancements in DBS. The procurement and integration of these additional back-up components will have a profound impact on our service- delivery. Salient Characteristics/ Compatibility Requirements: Brand Name or Equal Needs to be compatible with current Alpha Omega s Neuro Omega platform for Deep Brain Stimulation (DBS) Accuracy must be within 1 micron (.001 mm). Must filter, amplify, and digitize signals from the brain up to a foot away from patient head. Must minimize electromagnetic interference and other types of interference in the room Must be shielded with Tungsten or other equivalent material Must also measure Local Field potentials from each micro electrode on the implanted lead Must include Sterilization tray for Drive Headstage and Cable ECoG HeadBox HeadBox Cable HeadBox Holder Transformer Recording Only Drive and recording HeadStage must be one single assembly with electronic drive HeadStage must measure ECoG, EMG, EEG, and other electric signals from the body with up to 16 channels. 10 Channels must be able to record unfiltered raw, high frequency spike and low frequency LFP signals. There must be an ability to expand the amount of channels Must allow for trajectory adjustments without frame manipulation Must Drive up to 5 micro electrodes simultaneously Must utilize broadband filtering Only 1 cable shall be utilized to connect headstage to Neuro Omega No adaptors or connectors can be used HeadStage Drive and Cable must meet Robert Koch Institute recommendations for cleaning and sterilization of medical devices Must be usable with or without Stereotactic Frames Must be compatible with the following systems at a minimum Rosa ONE Brain Leksel Frame Must allow for implantation of DBS Electrode without altering the position of the drive or removing cannulas. Example Brand Name or Equal Schedule 1040051Leksell Vantage Key 1EA An instrument screw driver used with Leksell Vantage Stereotactic Arc System as well as with FirmFix pins during Leksell Vantage Head Frame …

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