50-H6901-25-CP309_062625 Abbott occluder SS UNMH.pdf.PDF

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AMPLATZER PICCOLO PDA OCCLUDER USE IN PEDIATRIC SURGERY
Solicitation number
50-H6901-25-CP309
Issued by
Bernalillo County, Albuquerque City, New Mexico

About this file

This document is a University of New Mexico (UNM) Proposed Sole Source Purchase Form for the procurement of the Amplatzer Piccolo PDA Occluder, a medical device for pediatric surgery. The request was submitted by Daniel Mills, Director of Cardiovascular Services, for Abbott as the sole vendor, with a proposed contract value of $70,000 annually for a three-year term with potential renewals consistent with New Mexico Procurement Code. The device is specifically designed for Patent Ductus Arteriosus (PDA) closure in premature infants weighing 700 grams and up, and is currently the only FDA-approved device of its kind in the United States.

The sole source justification is based on the device's unique technical specifications, including an extremely low-profile 4 F catheter delivery system, a self-expanding design for closing PDAs with specific dimensional requirements, a tightly woven single-layer mesh, and a flexible delivery cable that allows precise positioning. Abbott's address is listed as 8701 Bee Cave Road in Austin, Texas, and the document indicates that an extensive web search was conducted to confirm no alternative vendors could meet the specific medical device requirements. The form was electronically signed by Jeffrey Gilmore on June 26, 2025, and will be posted on the UNM Sunshine Portal and New Mexico Procurement website for the mandatory 30-day review period prior to purchase.

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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 6/26/2025 Requisition Number (If Applicable) Request Submitted by: Daniel Mills Title Dir of CV Services

Department Cardiology Email dwmills@salud.unm.edu Phone 9257644 Proposed Vendor Abbott Amount 70k/yr

Vendor Address 8701 Bee Cave RD Building 2 West Austin TX 78746

Term of Purchase

3 yrs w/ Renewals consistent W/NM Procurement Code

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:

Amplatzer Piccolo PDA Occluder use in Pediatric surgery

Why is this purchase needed?

The only U.S. approved device specifically designed and indicated for Patent Ductus Arteriosus (PDA) closure in premature infants, 700g and up.

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)

This is the only FDA approved device in the US at this time.

☐ Compatibility requirement with existing item, technology or service. (Check box and describe compatibility requirement) http://purchase.unm.edu/department-information/comm-code-listing.pdf

☐ 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.

• Extremely low-profile delivery—4 F catheter facilitates delivery in small vasculatures

• Self-expanding device designed for closure of a PDA with length longer than 3mm and diameter smaller than

4mm

• Tightly woven, single-layer mesh design to minimize residual shunt after placement

• Flexible delivery cable optimizes deployment and allows for representative preview of device orientation prior to release

• Predictable Placement—Disc size and shape designed for predictable positioning in the duct

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.

Extensive web search

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

N/A

Approved: _________________________________________________ Date: ___________________________

Jeffrey Gilmore (Jun 26, 2025 08:41 MDT) https://secure.na2.echosign.com/verifier?tx=CBJCHBCAABAAa5ka1ZBUv7AGxDVCg9_5NrQwbVtP1x8a

CCL Abbott occluder sole source Final Audit Report 2025-06-26

Created: 2025-06-26

By: Sherry Tackett (SLTackett@salud.unm.edu)

Status: Signed

Transaction ID: CBJCHBCAABAAa5ka1ZBUv7AGxDVCg9_5NrQwbVtP1x8a

"CCL Abbott occluder sole source" History Document created by Sherry Tackett (SLTackett@salud.unm.edu) 2025-06-26 - 12:51:33 PM GMT- IP address: 206.192.168.19

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

2025-06-26 - 12:52:04 PM GMT

Email viewed by Jeffrey Gilmore (jcgilmore@salud.unm.edu) 2025-06-26 - 2:41:26 PM GMT- IP address: 174.50.85.67

Document e-signed by Jeffrey Gilmore (jcgilmore@salud.unm.edu) Signature Date: 2025-06-26 - 2:41:41 PM GMT - Time Source: server- IP address: 174.50.85.67

Agreement completed.

2025-06-26 - 2:41:41 PM GMT

File details come from the government source that posted it. Updated .