Medtronic FAR 13.5 Sole Source Justification Redact_Redacted.pdf

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DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FEDERAL ACQUISTION REGULATION (FAR) 13.5

Acquisition Plan Action ID:

1. Contracting Activity: Department of Veterans Affairs

Network Contracting Office 16 (NCO 16) 1100 North College Avenue Fayetteville, AR 72703

Organizational Activity: Department of Veterans Affairs

Michael E. DeBakey VA Medical Center (MEDVAMC) 2002 Holcombe Boulevard

Houston, TX 77030

2237:

2. Nature and/or Description of the Action Being Processed:

This single source procurement is for a Medtronic Visualase brain ablation laser system in accordance with FAR 13.106-1(b)(2) and FAR 13.5 Simplified Procedures. This will be awarded as a new contract as a firm-fixed-price award.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The Neurosurgery Service at MEDVAMC is requesting the acquisition of a Medtronic V2 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. The V2 system can provide an MRI co-witness for pinpoint accuracy. LITT will benefit 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.

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( x ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services

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( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

As indicated by market research, only one available source is able to provide this requirement due to the highly technical aspect of this surgical equipment, the Original Equipment Manufacturer (OEM) does not have an authorized distributors at this time. The OEM, which is Medtronic (Large Business), does have a VA FSS contract in place 36C10G24D0037. However, this highly specialized equipment is not listed on that FSS contract at this time, it is unlikely to be added as most facilities do not perform open-brain surgical procedures. The V2 Visualase system has the ability to co-witness with the current MRI and provide surgical pin point accuracy for the brain procedures reducing patient complications and speeding up recovery times.

With no other systems capable of perform these functions and also provide compatibility with all the equipment in the surgical suite. Due to these facts, Medtronic is the only firm capable of providing the required equipment. If this requirement is not sole sourced to Medtronic, the stability of care to Veterans would be affect patient safety and would affect medical center operations.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Sources Sought / Notice of Intent (NOI) 36C25625Q1213 posted to Contract Opportunities on 07-17- 2025 and closed on 07-25-2025 for possible authorized /certified contractors to respond to this Government needed. No responses received from the NOI. Additional market research conducted indicated that the Original Equipment Manufacturer (OEM), Medtronic Inc., does not have any authorized distributors for this machine. In addition, the surgical team has conducted extensive research into finding a machine that would be compatible with the current surgical suite equipment.

Medtronic Inc. is a proven vendor and leader in the medical technology market. They are the only contractors capable of providing the required machine. Due to that fact, it is recommended to award on a sole source basis Medtronic Inc. to acquire the machine needed for the neuro-surgery team.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The surgical team has determined that this V2 Visualase system would increase the capabilities of doing complex surgical procedures in house and avoid costly outsourcing. The increase in costs for the V2 system would offset the costs within a few surgical procedures due to the higher cost of outsourcing surgery and inpatient care.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

Sources Sought / Notice of Intent (NOI) 36C25625Q1213 posted to Contract Opportunities on 07-17- 2025 and closed on 07-25-2025 for possible authorized /certified contractors to respond to this Government needed. No responses received from the NOI. Additional market research conducted indicated that the Original Equipment Manufacturer (OEM), Medtronic Inc., does not have any