6515--Consignment Agreement - Heart Valves - Ann Arbor
Closed Special Notice Posted
A later notice was posted: the Limited / Sole Source Justification from .
- Solicitation number
- 36C25025Q0759
- Agency
-
Veterans Integrated Service Network 10
Veterans Health Administration, Department of Veterans Affairs
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 339113 Surgical Appliance and Supplies Manufacturing
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Veterans Affairs Ann Arbor Healthcare System has issued a Special Notice announcing its intent to enter into a sole source contract with Edwards Lifesciences LLC for a consignment agreement covering transcatheter heart valves. The notice, published under solicitation number 36C25025Q0759, pertains to the procurement of SAPIEN 3 Ultra heart valves with RESILIA tissue technology, specifically two models: 26M and 29M transcatheter heart valves. The VA intends to negotiate this contract under Simplified Acquisition Procedures and plans to award a firm fixed price requirements contract with a 5-year ordering period. The procurement falls under NAICS code 339113 for Surgical Appliance and Supplies Manufacturing and is valued as a simplified acquisition. Edwards Lifesciences LLC of Irvine, California has been identified as the sole source vendor capable of meeting the government's requirements without unacceptable delays.
The primary purpose of this consignment agreement is to allow the VA Ann Arbor Healthcare System to maintain short shelf-life heart valves on-site and only purchase them when actually used in patient procedures. The government justifies the sole source approach by emphasizing that Edwards Lifesciences' SAPIEN 3 Ultra valves are the only FDA-approved balloon-expandable heart valves with advanced calcium-blocking technology, and as of May 1, 2025, they represent the only heart valve approved for asymptomatic severe aortic stenosis populations. Any interested parties wishing to challenge this sole source determination must provide clear and convincing evidence that competition would be advantageous to the government, with responses due by 4:30 PM on July 23, 2025. The notice explicitly states that it is not a request for competitive proposals or a solicitation for offers, and no solicitation package is available. The government maintains that only Edwards Lifesciences possesses the required capabilities to successfully meet the specialized medical requirements for these critical cardiac procedures.
Notice text
Notice of Intent to Sole Source Requirement
The Department of Veterans Affairs, VA Ann Arbor Healthcare System, NCO 10 Contracting Activity intends to negotiate a sole source contract under Simplified Acquisition Procedures and the authority of FAR 13.106-1(b)(2), Soliciting from a single source for the following items listed below. The associated NAICS code for this is 339113. The vendor will be Edwards Lifesciences LLC, 1 Edwards Way, Irvine, CA 92614.
Description of requirements:
Consignment contract for the following items:
Description
Model#
Transcatheter Heart Valve, 26M
S3URCM26A
Transcatheter Heart Valve, 29M
S3URCM29A
Consignment agreements allow the VA to keep several of these short shelf-life items in the facility without having to buy them until they are used. Edwards Lifesciences LLC SAPIEN 3 Ultra heart valves powered by RESILIA tissue are the only balloon-expandable heart valves. The SAPIEN 3 has an advanced calcium-blocking technology and patients with aortic FboNotice anatomy such as low coronary height, effaced sinuses of Valsalva, valve-in-valve can be treated with the SAPIEN 3. As of May 1, 2025, the FDA approved the SAPIEN 3 for the asymptomatic severe aortic stenosis population. This is the only heart valve with that indication. The SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (failing, stenosed, insufficient or combined) who are judged by a Heart Team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. The cardiologist chooses the particular heart valve being ordered during his consult and this is the only one that the doctor deemed appropriate for use in these specific medical situations. The supplies are selected based on their specific use during procedures. Edwards Lifesciences, LLC is the only firm capable of providing the supplies described in Section 3 above without the Veterans Health Administration experiencing unacceptable delays in fulfilling its requirements.
A firm fixed price requirements contract with a 5-year ordering period is anticipated and shall be awarded. It is the Government's belief that only the proposed candidate possesses the required capabilities to successfully meet this requirement. It is the Government's intention to solicit and negotiate with only this source.
This notice of intent is not a request for competitive proposals. It is not a solicitation or request for offers. No solicitation package is available. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. Responses must be received no later than 4:30 pm on Wednesday, July 23, 2025.
Kellie Konopinski
Contracting Officer
(734) 222-4330
Kellie.Konopinski@va.gov
Files
| File | Type | Posted |
|---|---|---|
| 36C25025Q0759.docx | DOCX document |
Notice history
| Notice | Type | Posted |
|---|---|---|
| 6515--Consignment - Heart Valves - Ann Arbor | Limited / Sole Source Justification | |
| This notice | Special Notice |
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