6515--Consignment Agreement - Heart Valves - Ann Arbor

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Contract Opportunity

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

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