ATTACHMENT H - BNJ NX EQ PHYSIOLOGIC MOTILITY ANALYZERS EndoFLIP- FE.pdf

DEPARTMENT OF VETERANS AFFAIRS

Office of Procurement, Acquisition and Logistics (OPAL)

Enterprise Procurement Office 5202 Presidents Ct, Suite 103

Frederick, MD 21703

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION -

BRAND NAME JUSTIFICATION

(1) Identification of the agency and the contracting activity, and specific identification of the document as a "Justification for Other Than Full and Open Competition."

This Justification and Approval (J&A) for Other Than Full and Open Competition is executed by the Enterprise Procurement Office (EPO), on behalf of the Veterans Health Administration (VHA), Office of Supply Chain.

(2) Nature and/or description of the action being approved.

The proposed action is for a Brand Name acquisition under a Firm-Fixed Price (FFP) Requirements Contract for a 60-month ordering period. This contract will support decentralized delivery orders for the Medtronic EndoFLIP™ 300 (Functional Lumen Imaging Probe) and related accessories. This acquisition is unrestricted and open to all business sizes.

This acquisition is part of the Equipment Life Cycle Management (ELCM) Program, which identified this system as critical for VA-wide standardization to improve patient care and operational efficiency.

(3) A description of the supplies or services required to meet the agency’s needs (including the estimated value).

The Department of Veterans Affairs (VA) has a requirement for the Medtronic EndoFLIP™ 300. The EndoFLIP™ 300 provides real-time measurements of the pressure and dimensions of the esophagus during endoscopic evaluation and surgical procedures through Impedance Planimetry. Impedance Planimetry is described as a catheter-mounted, balloon-covered probe placed during a regular endoscopy using sedation and inflated to prespecified pressures. During inflation, pressure sensors along the balloon measure intraluminal pressure and cross-sectional area within a gastrointestinal lumen or sphincter. The measurements are used to calculate a distensibility index (mm2/mm Hg) or compliance of the evaluated area. Additionally, the esophageal contractile pattern in response to balloon inflation can be assessed and may suggest the presence of contractile disorders of the esophagus.

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The EndoFLIP™ 300 is a well-tolerated and convenient way to assess esophageal motility that can inform the management of esophageal motility disorders. This is accomplished through utilizing a balloon catheter with impedance electrodes to evaluate the biomechanical properties (distensibility and compliance) of the GI tract During surgical procedures. The EndoFLIP™ 300 gives real-time feedback and measurements, providing, in some cases, a more precise evaluation of strictures or sphincter functionality than traditional methods which can confirm the need for and reduce negative outcomes of procedures like Nissen fundoplication, Heller myotomy, and peroral endoscopic myotomy (POEM). It is primarily used to study patients with swallowing difficulties. The technology is used alongside other diagnostic studies such as esophageal manometry and barium swallow to evaluate esophageal function, once structural abnormalities, such as esophageal strictures (narrowing of the esophagus), and other obstructions have been ruled out through esophagogastroduodenoscopy.

Impedance Planimetry through the use of Endoluminal Functional Lumen Imaging Probe technology is proprietary to Medtronic’s EndoFLIP™ system.

Estimated Value:

The estimated value for this contract, $7,772,653.33, includes the procurement, delivery, maintenance, and technical support for the Medtronic EndoFLIP™ (Functional Lumen Imaging Probe) and ancillary components over the 60-month period.

(4) An identification of the statutory authority permitting other than full and open competition.

The statutory authority permitting other than full and open competition is 41 U.S.C.

3304(a)(1), as implemented by the Federal Acquisition Regulation (FAR) 6.103-1, "Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements – Application for Brand Name Descriptions"

(5) A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

The rationale for a Brand Name acquisition of the EndoFLIP™ 300 system (Medtronic) centers on its unique, patented impedance planimetry technology, which provides real-time, intraoperative, radiation-free, three-dimensional assessment of gastrointestinal sphincter function (distensibility and pressure). No other device offers the same combination of diagnostic and therapeutic (EsoFLIP) capabilities, making it essential for specific procedures like achalasia, GERD, and motility disorder evaluations.

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Key Rationale for Brand Name Justification:

- Unique Technology: EndoFLIP™ is the only device that utilizes impedance planimetry to measure the diameter and cross-sectional area of the esophagus during endoscopic procedures. It is the only device capable of measuring both diameter and pressure.

- Real-time Intraoperative Data: It provides immediate, direct visualization of the esophagogastric junction (EGJ) during surgery (e.g., fundoplication), allowing for instant adjustment of the surgical procedure. It is the only device capable of providing both real-time diameter information and pressure mapping.

- Alternative to Radiation: It removes the need for X-rays (fluoroscopy) during esophageal, pyloric, or anorectal measurements.

- Diagnostic and Therapeutic Capability: Beyond diagnostic, the system includes

EsoFLIP catheters, which combine measurement with therapeutic dilation. Standard of Care: The Chicago 4.0 classification system, used to interpret motility data, incorporates EndoFLIP™, making it crucial for modern, accurate, and standardized diagnosis.

By using Medtronic EndoFLIP™, clinicians can achieve more precise, tailored procedures with fewer complications.

(6) A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required subpart 5.1 and, if not, which exception under

5.101 applies.

Extensive market research was conducted, the details of which are documented in the Market Research Worksheet. After thorough investigation, it was determined that no other sources could meet the comprehensive requirements established by the VA. The proposed action will be synopsized on the Federal Business Opportunities Page in accordance with FAR 5.101, and any proposals received will undergo evaluation.

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(7) A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer will ensure that the cost to the Government is fair and reasonable prior to any award being made. This will be evaluated through a comparison of the below:

a. Comparison of the proposed prices to historical prices paid, whether by the

Government or other than the Government, for the same or similar items.

b. Comparison with competitive published price lists of similar products, published market prices of commodities, similar indexes, and discount or rebate arrangements.

c. Comparison of proposed prices with Independent Government Cost Estimates.

(8) A description of the market research conducted (see part 10) and the results or a statement of the reason market research was not conducted.

The NAICS code for this acquisition is 339113 - Surgical Appliance and Supplies Manufacturing. Market research established the Government’s needs can be met through the acquisition of commercial supply items and services. The contracting officer determined that Physiologic Motility Analyzers are commercial in nature. Market research was conducted pursuant to the requirements set forth in FAR Part 10.

Market research between November 2025 through April 2026 involved a review of similar previous procurements through search engines of open market contractors and Federal Supply Schedule contractors. Search engines utilized included Google, Bing, GSA Advantage, VetBiz.gov, SBA Dynamic Small Business (DSBS) website, and the ECRI sourcebook catalog. An RFI was posted on FBO.gov for 10 business days. It was posted on 03/18/2026 and the closing date was 03/31/2026. No alternative sources were identified capable of meeting the Government’s needs.

Additionally, the proposed action will be synopsized on the Federal Business Opportunities Webpage in accordance with FAR 5.101 and made available with the published solicitation in accordance with FAR 6.301(b). Any proposals that are received shall receive consideration and be evaluated to the extent capable of meeting agency needs.

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(9) Any other facts supporting the use of other than full and open competition.

Standardization of this equipment across VA facilities will:

• Reduce training complexity.

• Improve interoperability and maintenance.

• Enhance patient safety and diagnostic consistency.

(10) A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

Veterans Healthcare Supply Solutions, SDVOSB 2615 Port Industrial Dr., Suite 405 Jacksonville, FL 32226

BHPE, SDVOSB

10601 S Western AVE STE 113 Oklahoma City, OK 73170

(11) A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

For future acquisitions, the Government will conduct new market research to identify authorized distributors and OEMs capable of meeting this requirement. This research will assess any changes in the marketplace that could enable competitive procurement strategies.

All future requirements will be evaluated on a case-by-case basis to determine the most appropriate acquisition approach, with the intent to maximize competition whenever practicable.

Enterprise Procurement Office 5202 Presidents Ct, Suite 103

Frederick, MD 21703

(12) Evidence that any supporting data that is the responsibility of technical or requirements personnel (e.g., verifying the Government’s minimum needs or requirements or other rationale for an exception to fair opportunity) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.

I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

Signature: _________________________________ Daniel R. King (Dan) Deputy Program Manager VHA CO Procurement & Logistics Office (19PLO)

(13) Contracting officer certification that the justification is accurate and complete to the best of the contracting officer ’s knowledge and belief.

I certify that this justification is accurate and complete to the best of my knowledge and belief. Furthermore, I determine that the anticipated price to the Government for this action will result in fair and reasonable prices paid based on the rationale provided herein.

Signature: _________________________________ Anthony Zibolski Contracting Officer Enterprise Procurement Office

Enterprise Procurement Office

(14) Competition Advocate certification that the justification is accurate and complete to the best of the advocate’s knowledge and belief.

In my role as Procuring Activity Advocate for Competition, based on the foregoing justification, I hereby approve this acquisition on an “other than full and open competition” basis pursuant to the statutory authority cited in paragraph four above, subject to availability of funds, and provided that the property and services herein described have otherwise been authorized for acquisition. As this action does not exceed $20M, the certification below required by FAR 6.104-2 serves as approval.

Signature: _________________________________

Efrain J. Fernandez Director of Contracts & Procuring Activity Advocate for Competition Enterprise Procurement Office