50-H6901-25-CP142_040425 Medtronic SS UNMH.pdf.PDF

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RE HOSTING OF SOFTWARE-PREV EMER 50-C0027-25-EM028
Solicitation number
50-C0027-25-EM046
Issued by
Sandoval County, New Mexico

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This is a University of New Mexico Hospital (UNMH) Proposed Sole Source Purchase Form for Medtronic's Endoflip™ 300 Impedance Planimetry System, submitted on April 3, 2025. The document details a procurement for EndoflipTM 300 disposable catheters (specifically EF-322N and EF-325N models) to be used in esophageal diagnostic and surgical procedures. The proposed purchase is for a one-year term with an estimated annual spend of $113,000, covering disposable medical devices required to perform esophageal examinations and surgical interventions.

The sole source justification centers on the unique technological capabilities of the Endoflip system, which provides real-time measurements of esophageal pressure and dimensions during endoscopic evaluations. The procurement is based on the product's proprietary high-resolution impedance planimetry technology, which is described as the only product on the market capable of measuring esophageal diameter at 16 points, displaying lower esophageal sphincter (LES) distensibility index, and showing real-time contractility patterns. No alternative vendors were identified that could meet the hospital's specific diagnostic and surgical requirements, making Covidien Sales LLC (Medtronic) the sole source provider for these specialized medical devices.

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UNM Proposed Sole Source Form – Rev 04/07/2021

Proposed Sole Source Purchase Form Pursuant to New Mexico Procurement law, the UNM Purchasing Department will post your completed form on the UNM Sunshine

Portal and the State of New Mexico Procurement website for 30 days prior to purchase of the goods/services.

I. GENERAL INFORMATION. PLEASE PROVIDE THE FOLLOWING:

Date of Request 4-3-25 Requisition Number (If Applicable) NA Request Submitted by: Christina Ward Lechalk Title Procurement

Specialists Department UNMH OR Email cwardlechalk@salud.unm.edu Phone 505-410-6542

Proposed Vendor Covidien Sales LLC (Medtronic) Amount $ 113,000.00 Vendor Address 3555 Kroger BLVD Suite 200 Duluth GA,30096 Term of Purchase 1 year disposables

Buyer Team - See Commodity list at http://purchase.unm.edu/department-information/comm-code-listing.pdf

Provide a basic description of goods/services to be provided:

EndoflipTM 300 Impedance Planimetry System Endoflip™ 300 provides real-time measurements of the pressure and dimensions of the esophagus during endoscopic evaluation and surgical procedures. Endoflip™ 300 is a well-tolerated, convenient way to assess esophageal motility that can inform the need to refer patients to high-resolution manometry. During surgical procedures Endoflip™ 300 gives real-time feedback that can reduce negative outcomes of procedures like Nissen fundoplication, Heller myotomy, and per-oral endoscopic myotomies. The disposables are estimated at $113,000.00 per year and that is why this sole source is being posted.

Why is this purchase needed?

UNMH has purchased this equipment but the disposables will be required to perform the procedures.

EF-322N ENDO CATHETER 16CM NASAL TIP

2 EF-325N ENDO CATHETER 8CM NASAL TIP

II. BASIS FOR SOLE SOURCE PROCUREMENT. CHOOSE APPLICABLE BOX(ES) AND

PROVIDE ADDITIONAL INFORMATION, AS REQUESTED:

☒ Proprietary item, technology or service only available from the proposed vendor. (Check box and describe proprietary component) http://purchase.unm.edu/department-information/comm-code-listing.pdf

Endoflip™ technology uses high-resolution impedance planimetry to measure luminal geometry and pressure during volume-controlled distension. It helps you assess the mechanical properties of the esophageal wall and opening dynamics of the gastroesophageal junction in various esophageal diseases. The patient is sedated and is well-tolerated. This is the only product on the market along with disposables that provides this type of diagnostic testing, esophageal dilation and intraoperative feedback both in traditional and endoscopic surgery.

☒ Compatibility requirement with existing item, technology or service. (Check box and describe compatibility requirement)

This equipment is currently in existence at UNMH.

☐ Renewal of support/maintenance/subscription of software, technology or other intellectual property. (Check box and describe)

☐ Other Basis for Sole Source: Please describe below:

III. SUPPLEMENTAL DETAILS. PLEASE PROVIDE ADDITIONAL INFORMATION AS

REQUESTED BELOW:

Describe in detail the unique capabilities of the proposed vendor’s goods/service and/or personnel performing the work and why this constitutes the only source. Focus on what is unique about the goods/service and why no other vendor could meet your needs.

Endoflip™ technology uses high-resolution impedance planimetry to measure luminal geometry and pressure during volume-controlled distension. It helps you assess the mechanical properties of the esophageal wall and opening dynamics of the gastroesophageal junction in various esophageal diseases. The patient is sedated and is well-tolerated. This is the only product on the market that provides this type of diagnostic testing, esophageal dilation and intraoperative feedback both in traditional and endoscopic surgery. This is the only technology that provides esophageal diameter at 16 points, distensiblity index at the LES, and displays contractility patters of the LES in real-time.

Describe the due diligence made to locate other possible sources including communications with other universities, communications with similar providers, web searches, yellow page searches, review of advertisements and trade publications, etc.

Currently there is no other disposables except from this vendor.

List the other vendors who were contacted. Please describe the specs/qualifications/criteria that the other vendors were unable to satisfy.

None available.

Signature Date Director of Purchasing UNMH

Jeffrey Gilmore (Apr 3, 2025 16:35 MDT) Apr 3, 2025 https://secure.na2.echosign.com/verifier?tx=CBJCHBCAABAAMsVrqhNpAt9A-iwjiIz48FL3Ug3xEr6r

Sole Source for Medtronic Endoflip cathaters required to perform the procedures. Spend is $113,000.00 estimated per year.

Final Audit Report 2025-04-03

Created: 2025-04-03

By: Christina Ward (cwardlechalk@salud.unm.edu)

Status: Signed

Transaction ID: CBJCHBCAABAAMsVrqhNpAt9A-iwjiIz48FL3Ug3xEr6r

"Sole Source for Medtronic Endoflip cathaters required to perfor m the procedures. Spend is $113,000.00 estimated per year." Hi story

Document created by Christina Ward (cwardlechalk@salud.unm.edu) 2025-04-03 - 9:42:03 PM GMT- IP address: 206.192.168.18

Document emailed to Jeffrey Gilmore (jcgilmore@salud.unm.edu) for signature

2025-04-03 - 9:42:36 PM GMT

Email viewed by Jeffrey Gilmore (jcgilmore@salud.unm.edu) 2025-04-03 - 10:35:21 PM GMT- IP address: 206.192.168.22

Document e-signed by Jeffrey Gilmore (jcgilmore@salud.unm.edu) Signature Date: 2025-04-03 - 10:35:30 PM GMT - Time Source: server- IP address: 206.192.168.22

Agreement completed.

2025-04-03 - 10:35:30 PM GMT

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