Procurement Summary
Country : USA
Summary : Consignment Agreement - Heart Valves - Ann Arbor
Deadline : 23 Jul 2025
Other Information
Notice Type : Tender
TOT Ref.No.: 123057246
Document Ref. No. : 36C25025Q0759
Financier : Self Financed
Purchaser Ownership : Public
Tender Value : Refer Document
Purchaser's Detail
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Description
Notice of Intent to Sole Source RequirementThe 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: DescriptionModel#Transcatheter Heart Valve, 26MS3URCM26ATranscatheter Heart Valve, 29MS3URCM29AConsignment 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 describe...
Active Contract Opportunity
Notice ID : 36C25025Q0759
Related Notice
Department/Ind. Agency : VETERANS AFFAIRS, DEPARTMENT OF
Sub-tier : VETERANS AFFAIRS, DEPARTMENT OF
Office: 250-NETWORK CONTRACT OFFICE 10 (36C250)
General Information
Contract Opportunity Type: Special Notice (Original)
Original Published Date: Jul 18, 2025 03:40 pm EDT
Original Response Date: Jul 23, 2025 04:30 pm EDT
Inactive Policy: Manual
Original Inactive Date: Oct 30, 2025
Initiative: None
Classification
Original Set Aside:
Product Service Code: 6515 - MEDICAL AND SURGICAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES
NAICS Code: 339113 - Surgical Appliance and Supplies Manufacturing
Place of Performance:
Documents
Tender Notice
36C25025Q0759.docx