SAM #36C24426Q0631

VA Seeks Leksell Vantage Stereotactic Instruments for DBS Procedures in Philadelphia

The Department of Veterans Affairs, through Network Contracting Office 4, is seeking information from vendors for the supply of Leksell Vantage Stereotactic Instruments and accessories to support Deep Brain Stimulation (DBS) procedures at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia. - Government Buyer: - Department of Veterans Affairs, Network Contracting Office 4 - Contracting Office located in Pittsburgh, PA - OEMs and Vendors Mentioned: - Leksell (manufacturer of Vantage Stereotactic Instruments) - Alpha Omega (referenced for compatibility with Neuro Omega platform) - Products/Services Requested: - Leksell Vantage Key (part number 1040051), qty 1 - Leksell Vantage Cross-Hairs Kit (1040025), qty 1 - Leksell Vantage Head Frame (1040036), qty 1 - Leksell Vantage Arc System (1040048), qty 1 - Leksell Vantage Arc Tray (1040045), qty 1 - Vantage Starburst 3/8 (1040093), qty 1 - Leksell Vantage Frame Holder (1040114), qty 1 - EN/Leksell Vantage/QRG (1556500), qty 1 - EN/LVSS ARC System/QRG (1569126), qty 1 - EN-US/Leksell Vantage System/IFU (1572849), qty 1 - Unique or Notable Requirements: - All items must be compatible with the Alpha Omega Neuro Omega platform and other systems such as Rosa ONE Brain and Leksell Frame - High accuracy (within 1 micron), signal filtering and amplification, electromagnetic interference minimization, tungsten shielding, and sterilization compliance - Expandability for additional channels - Vendors must provide evidence of authorized distributor status from the OEM - Place of Performance: - Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Description

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 backups 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 backup 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 number 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 used 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, Leksell Frame. Must allow for implantation of DBS Electrode without altering the position of the drive or removing cannulas. Example Brand Name or Equal Schedule 1040051 Leksell Vantage Key - 1EA: An instrument screwdriver used with Leksell Vantage Stereotactic Arc System and FirmFix pins during Leksell Vantage Head Frame Fixation. Made of titanium and aluminum. 1040025 Leksell Vantage Cross-Hairs - 1EA: Used to check the placement of inserted electrodes, catheters, or other instruments in relation to the set target point. MR Unsafe. 1040036 Leksell Vantage Head Frame - 1EA: Provides open space in front of the face, MR Safe, designed for head sizes between 49 and 62 cm in circumference. 1040048 Leksell Vantage Arc System - 1EA: Allows selection of any desired trajectory to the target, MR Conditional. 1040045 Leksell Vantage Arc Tray - 1EA: Sterilization tray for parts of the Arc System, Key, and Cross-Hairs. 1040093 Vantage Starburst 3/8 - 1EA: Includes interface, screw, and Allen key for fixing to the Frame Holder. 1040114 Leksell Vantage Frame Holder - 1EA: Holds the Head Frame in position during procedures and imaging. 1556500 EN/Leksell Vantage/QRG - 1EA 1569126 EN/LVSS ARC System/QRG - 1EA 1572849 EN-US/ Leksell Vantage System /IFU - 1EA Request for Information Instructions The information above is descriptive, not restrictive, and indicates the quality of supplies/services that will be satisfactory. It is the responsibility of interested sources to demonstrate their ability to provide the required supplies/services. Responses should include company name, address, point of contact, phone number, email, UEI Number, Cage Code, and business size per NAICS 339114. Please answer the following questions: Indicate your business size status and representations (e.g., SDVOSB, VOSB, Hubzone, WOSB, Large Business). Is your company considered small under NAICS 339114? Are you the manufacturer, distributor, or an equivalent solution provider? If not, provide additional information to confirm compliance with the non-manufacturer rule. Does your company exceed 500 employees? Are you primarily engaged in retail or wholesale trade of these items? Do you take ownership or possession of the items in a manner consistent with industry practice? Have you obtained any waivers? If a large business, do you have designated distributors? Provide their details. If a small business and an authorized distributor/reseller, do you alter, assemble, or modify the items? Must have an authorized distributor letter from the OEM. If subcontracting, what portion of the work will be performed by your organization? Do you have an FSS contract with GSA or NAC, or other federal contracts? Provide contract number. Are the items available on your schedule/contract? Provide general pricing information for market research purposes. Submit capabilities regarding the salient characteristics and any equal items. Review the salient characteristics and provide feedback or suggestions, or reply as N/A. Provide equipment manufacture country of origin and UEI number. This RFI is for information and planning only, not a solicitation. Responses must be sent via email to andrew.taylor3@va.gov by 4:00 PM ET on May 29, 2026. Do not contact VA staff regarding this requirement. Questions should be addressed to the Contracting Officer, Andrew Taylor, with the subject line including "36C24526Q0631". Responses are not offers and will not be considered for award. A capability statement should not exceed 10 pages and must include how the business sells and takes ownership of items, and proof of authorized distributor status. If a solicitation is issued, it will be posted on SAM. This notice does not commit the government to any contract. The government will not pay for responses. All responses should be in writing via email to andrew.taylor3@va.gov with the subject line "36C24426Q0631". Disclaimer: This RFI is for information and planning only, not a solicitation. All proprietary information will be handled accordingly. Responses are not offers and cannot be accepted as a contract. Responders are responsible for all expenses incurred. End of Document

Additional Links: Philadelphia VA Medical Center

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