6515--Leksell Vantage Stereotactic Instruments Brand name or Equal to This is not a request for quotes

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 Fixation. Index bits Hex 3 and 4 are made of titanium while the rest of the Leksell Vantage Key is made of aluminum. 1040025 Leksell Vantage Cross-Hairs 1EA Leksell Vantage Cross-Hairs Kit in Stainless Steel is used with Leksell Vantage Stereotactic System to intraoperatively check the placement of inserted electrodes, catheters or other instruments in relation to the set target point. The cross-hair has two parts. The cross plate has a thin pattern of a cross and the ring plate has a thin pattern of concentric rings. This difference makes it easy to find the line of sight in the X-ray images. Both the ring plate and the cross plate are equipped with rubber O-rings that ensure secure attachment to the rings of the arc. The cross-hairs is MR Unsafe. 1040036 Leksell Vantage Head Frame 1EA This design of the head frame gives an open space in front of the face area. Therefore, it gives space for intubation of the patient if necessary in an emergency situation. The frame is MR Safe. The frame is designed for head sizes between 49 and 62 cm in circumference. The head width can be 134-175 mm in range and length 167-215 mm in range. The Leksell Vantage Key is used for FirmFix pin head frame fixation and for Leksell Vantage Stereotactic Arc target coordinate settings. 2 x Leksell Vantage Keys are included. 1040048 Leksell Vantage Arc System 1EA Leksell Vantage Arc System is designed to allow the surgeon to select any desired trajectory to the predetermined target, regardless of the patient"s position, when using together with Leksell Vantage Head Frame. It is used for diagnostic and therapeutic procedures, such as functional interventions and minimal invasive neurosurgical procedures within its intended use. The arc system is MR Conditional. 1040045 Leksell Vantage Arc Tray 1EA The sterilization tray is used for the sterilization procedure of the parts of the Leksell Vantage Arc System, Leksell Vantage Key and Leksell Vantage Arc Cross-Hairs. 1040093 Vantage Starburst 3/8 1EA Includes the Starburst interface for operating table base units with 3/8 screw interface, the starburst screw, and allen key 6 mm that are used to fix the starburst to the Leksell Vantage Frame Holder. 1040114 Leksell Vantage Frame Holder 1EA Holds the Leksell Vantage Head Frame in position when interfacing to operating tables and diagnostic CT scanner tables. It is used in the operating theatre together with Starburst interfaces. It is also used during CT imaging where it is attached to the Leksell Vantage Frame Holder Extension. 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 identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications mentioned above. Responses to this RFI should include company name, address, point of contact, phone number, and point of contact e-mail, UEI Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS) 339114 Please answer the following questions: Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)? Is your company considered small under the NAICS code identified under this RFI? Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? If not, can you provide additional information shown below. This is to confirm compliance with the non-manufacturer rule IAW 13 CFR 121.406(b) Nonmanufacturers. Does your company exceed 500 employees; Primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied; Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice; Obtained an individual or class waiver? If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available).
If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? Must have an authorized distributor letter from the original equipment manufacture. If you intend to subcontract any work on this contract, what portion of the total cost will be self-performed/will be performed by your organization? Please provide estimated detailed percentage breakdowns related to subcontracted work and completion of job. Does your company have an FSS contract with GSA or the NAC or are you a contract holder with any other federal contract? If so, please provide the contract number. If you are an FSS GSA/NAC contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract? General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award. Please submit your capabilities in regard to the salient characteristics detailed above and any information pertaining to equal to items to establish capabilities for planning purposes? Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A. Equipment manufacture, Country of origin Please provide your UEI number. This RFI will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 12. Telephone responses will not be accepted. Responses must be received via e-mail to andrew.taylor3@va.gov no later than, 4:00 PM Eastern Time (ET) on May 29, 2026. This notice will help the VA in determining available potential sources only. Do not contact VA Medical Center staff regarding this requirement, as they are not authorized to discuss this matter related to this procurement action. All questions will be addressed by the Contracting Officer, Andrew Taylor. Questions or responses will include the Source Sought number 36C24526Q0631 in the subject line. All firms responding to this Request for Information are advised that their response is not a request for quotes, therefore will not be considered for a contract award from this request. Any interested business concern must submit a no longer that 10-page capability statement addressing its ability to meet the requirements listed above to Capability Statement shall include a statement regarding how the business concern is engaged in wholesale trade and normally sells the item being supplied and how the business concern will take ownership of the items being delivered. Vendors shall also provide certification, evidence that they are an authorized distributor of the Original Equipment Manufacturer. If a solicitation is issued, information will be posted on the SAM web site for all qualified interested parties at a later date and interested parties must respond to the solicitation to be considered for award. This notice does not commit the government to contract for any supplies or services. The government will not pay for any information or administrative cost incurred in response to this Request for Information. Information will only be accepted in writing by e-mail to Contracting Officer at andrew.taylor3@va.gov include 36C24426Q0631 in the subject line. DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. End of Document