36C25025Q0759.docx
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- Attached to
- 6515--Consignment Agreement - Heart Valves - Ann Arbor Federal contract opportunity
- Solicitation number
- 36C25025Q0759
About this file
This Special Notice is a sole source procurement by the Department of Veterans Affairs Ann Arbor Healthcare System for a consignment agreement for specific transcatheter heart valves from Edwards Lifesciences LLC. The contract will be a firm fixed price requirements contract with a 5-year ordering period, covering two heart valve models: Transcatheter Heart Valve, 26M (S3URCM26A) and Transcatheter Heart Valve, 29M (S3URCM29M). The SAPIEN 3 Ultra heart valves are uniquely positioned as the only FDA-approved balloon-expandable heart valves with advanced calcium-blocking technology, specifically approved for asymptomatic severe aortic stenosis population as of May 1, 2025.
The solicitation (36C25025Q0759) is not a competitive proposal but a notice of intent to sole source, with responses due by 4:30 PM on July 23, 2025. The government asserts that Edwards Lifesciences is the only firm capable of providing these specialized medical supplies without causing unacceptable delays. The consignment agreement allows the VA to maintain short shelf-life items on-site and only purchase them when used, with the specific heart valves selected by cardiologists based on individual patient medical requirements. The procurement falls under NAICS code 339113 and will be processed using Simplified Acquisition Procedures.
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Text version
Special Notice Special Notice
| SUBJECT* |
| Consignment Agreement - Heart Valves - Ann Arbor |
GENERAL INFORMATION
| CONTRACTING OFFICE’S ZIP CODE* |
| 48105 |
| SOLICITATION NUMBER* |
| 36C25025Q0759 |
| RESPONSE DATE/TIME/ZONE |
| 07-23-2025 16:30 EASTERN TIME, NEW YORK, USA |
| ARCHIVE |
| 99 DAYS AFTER THE RESPONSE DATE |
| RECOVERY ACT FUNDS |
| N |
| PRODUCT SERVICE CODE* |
| 6515 |
| NAICS CODE* |
| 339113 |
| CONTRACTING OFFICE ADDRESS |
| Department of Veterans Affairs |
Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor MI 48105
POINT OF CONTACT*
Contracting Officer Kellie Konopinski Kellie.Konopinski@va.gov 734-222-4330
ADDITIONAL INFORMATION
AGENCY’S URL
URL DESCRIPTION
AGENCY CONTACT’S EMAIL ADDRESS
EMAIL DESCRIPTION
DESCRIPTION
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 root 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
| *= Required Field |
| Special Notice |
Special Notice
File details come from the government source that posted it. Updated .