6515--Visualase 15W Thermal Therapy System Medtronic USA

The Department of Veterans Affairs Michael E. DeBakey VA Medical Center (MEDVAMC) Network Contracting Office (NCO) 16 intends to issue and award a Sole Source single award Firm-Fixed Price type contract to Medtronic USA, for a Visualase 15W Thermal Therapy System at the MEDVAMC, located at 2002 Holcombe Boulevard, Houston, TX 77030. It has been determined that through initial Market Research, only 1 (one) responsible source can provide the required Brand Name equipment as identified below, in accordance with Federal Acquisition Regulation (FAR) 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements .

Model / Part Number

Item /Description of Supplies/Equipment

Qty

VTS-15

Visualase 15W Thermal Therapy System

1

THIS IS NOT A REQUEST FOR COMPETITIVE QUOTES/PROPOSALS AND NO SOLICIATION IS AVAILABLE.

Telephone requests will not be honored. No award will be made based on quotes or offers received in response to this notice. All responsible sources may identify their interest to meet this requirement to andrew.misfeldt@va.gov by 10:00 am (CST), Friday, 25, July 2025. Additionally, any response to this notice must show clear, compelling and convincing evidence that competition will be advantageous to the government by providing the following:

1.Business Size and Socio-Economic Status: (a) Indicate whether your business is large or small (b) If small, indicate if your firm qualifies as a small, emerging business, or small disadvantaged business (c) If disadvantaged, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act (d) Indicate if your firm is a certified Hub zone firm (e) Indicate if your firm is a woman-owned or operated business (f) Indicate if your firm is a VIP verified Service-Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) (g) Include the DUNS number of your firm. (h) State whether your firm is registered with the System for Award Management (SAM) at www.sam.gov and/or the VetBiz Registry at www.vetbiz.gov. If not, please NOTE: any future solicitation could only be awarded to a contractor who is registered in SAM. To receive award based on VOSB or SDVOSB status you must be registered in the VetBiz Registry.

2. Authorization to Perform: Prospective non-OEM contractors MUST provide an authorization letter from Medtronic identifying they are authorized to provide the required Original Equipment Manufacturer (OEM) parts/equipment.

The intent of this notice is for informational purposes only. Interested parties may submit information for consideration by the government to: andrew.misfeldt@va.gov no later than the response due date/time identified above.

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1

For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C256-25-AP-3763

Contracting Activity: Department of Veterans Affairs, VISN 16, NCO 16, Michael E. DeBakey VA Medical Center, Operative Care Line.

Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The Michael E. DeBakey VA Medical Center Neurosurgery Service at MEDVAMC is requesting the acquisition of the Medtronic Visualase Ablation System. Visualase is an MRI-guided laser ablation system used to perform laser interstitial thermal therapy (LITT), a minimally invasive surgical alternative to open crabiotomy. LITT will benefir patients with brain tumors, radiation necrosis, or medically refractory focal epilepsy. The Visualase system delivers laser energy through a small catheter into unwanted soft tissue targets in the brain. When laser energy is absorbed by the target tissue, temperature rises and, over time, creates an irreversibly damaged thermal lesion.

Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Medtronic is the sole manufacturer of this equipment. This is the only system that is certified to be compatible with all equipment in our surgical suite at this time.

Description of market research conducted and results or statement why it was not conducted: This Justification will be posted to SAM with a NOI to sole source. SDVOSB distributors and SB offerers were sought in the market research and none responded. The OR Team and Radiology services yielded that only this system was found to be fully compatible with the current equipment in the surgical suites. Medtronic is the sole vendor capable of providing the equipment.

Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.