6515--Mizuho T2 Aneurysm Clips Replacement clips for current kit

Active

Contract Opportunity

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 Mizuho OSI, for T2 Aneurysm Clips 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
17-001-01
Mizuho Sugita T2 aneurysm clips for use in open Brain Aneurysm procedures.
10
17-001-08
Mizuho Sugita T2 aneurysm clips for use in open Brain Aneurysm procedures.
10
17-001-09
Mizuho Sugita T2 aneurysm clips for use in open Brain Aneurysm procedures.
2
17-001-13
Mizuho Sugita T2 aneurysm clips for use in open Brain Aneurysm procedures.
2
17-001-15
Mizuho Sugita T2 aneurysm clips for use in open Brain Aneurysm procedures.
2
17-001-21
Mizuho Sugita T2 aneurysm clips for use in open Brain Aneurysm procedures.
2
17-001-25
Mizuho Sugita T2 aneurysm clips for use in open Brain Aneurysm procedures.
2

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), July 31, 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 Mizuho OSI 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-3764

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 (MEDVAMC) is currently requesting multiple Mizuho Sugita T2 aneurysm clips for use in open Brain Aneurysm procedures. Sugita T2 offer several advantages in aneurysm surgery, including a wide variety of blade shapes, lengths, and angles for complex aneurysms, a slim blade design with a tapered tip for access to difficult-to-reach areas, and an ultra-slim spring profile for enhanced handling and visibility. The clips also feature an atraumatic blade impact, preventing slippage and preserving tissue integrity, and are MRI conditional up to 3 Tesla. Additionally, it is made of high-grade titanium which offers excellent biological compatibility, durability, and wear resistance for permanent implantation, making the clips suitable for long-term aneurysm treatment.

Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Mizuho is the sole manufacturer of these surgical instruments. They are currently in use at MEDVAMC and these are replacement sets. With these clips going into kits already owned and in use by the VAMC this will be brand name only. A full replacement of a kit would be cost prohibitive in comparison to refilling the items needed.

Description of market research conducted and results or statement why it was not conducted: Posting this NOI on SAM for possible authorized distributors. Contacted the OEM for possible authorized distributors for these items with no results. An internet search and consult with the OR Team yielded that there is a sole vendor capable of providing the instruments.

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.

Attachments/Links