6515--Actionable-S1 | 554 | New Consignment | Edwards Lifesciences TAVR Heart Valves (VA-24-00068478)

Closed Special Notice Posted

This opportunity was awarded. See the award notice from .

Solicitation number
36C25925Q0100
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Notice details come from SAM.gov. Updated .

About this opportunity

The Department of Veterans Affairs (VA) Veterans Health Administration, specifically Network Contracting Office 19, has issued a Special Notice announcing its intent to award a sole-source procurement to Edwards Lifesciences LLC for specialized surgical heart valves. The notice pertains to the Rocky Mountain Regional VA Medical Center's requirement for SAPIEN 3 Transcatheter Heart Valves in varying sizes (23mm, 26mm, and 29mm). Located in Greenwood Village, Colorado, the VA has determined that Edwards Lifesciences is the sole manufacturer of these specific medical devices. The procurement will be conducted under the North America Classification Systems (NAICS) Code 339113, which relates to surgical appliance and supplies manufacturing. The contract will be structured as a consignment-based arrangement with a five-year performance period from December 20, 2024, to December 19, 2029.

Interested parties are invited to demonstrate their capabilities in responding to this requirement by submitting relevant information to thaddeus.gray@va.gov no later than 12:00 PM Mountain Standard Time on December 19, 2024. The VA emphasizes that this Special Notice is not a request for competitive quotes, but rather an opportunity for potential suppliers to confirm their ability to meet the government's specific needs. Contractors must provide comprehensive documentation such as specifications, cut sheets, brochures, and capability statements that clearly show they can supply the products outlined in the notice. While the opportunity is open for review, the government retains sole discretion in determining whether to compete the requirement based on the responses received. The VA also explicitly states that it will not be responsible for any costs incurred by interested parties in preparing their responses to this notice.

Notice text

Special Notice

Special Notice

Page 4 of 4

In accordance with FAR 13.501(a), this Notice of Intent is to inform all parties the Department of Veterans Affairs, Network Contracting Office (NCO) 19 located at 6162 South Willow Drive Suite 300, Greenwood Village, CO 80111 intends to award a sole source procurement for the following requirement to the large business manufacturer, Edwards Lifesciences LLC, 1 Edwards Way, Irvine California 92614.

The Rocky Mountain Regional VA Medical Center requires varying sizes of Edwards Lifesciences LLC prosthetic surgical heart valves SAPIEN 3 Transcatheter Heart Valves for patients on a consignment basis. The anticipated term of the requirements contract is five (5) years.

Consignment Items:

Part Number

Description

Quantity

S3URCM23A

23mm SAPIEN 3 Transcatheter Heart Valve

2

S3URCM26A

26mm SAPIEN 3 Transcatheter Heart Valve

3

S3URCM29A

29mm SAPIEN 3 Transcatheter Heart Valve

2

The projected period of performance: December 20, 2024 December 19, 2029.

In accordance with FAR Part 10 and VA Acquisition Regulation (VAAR) Part 810, the VA has conducted market research to arrive at the most suitable approach to acquiring prosthetic surgical implants and maintaining the necessary supply chain. Edwards Lifesciences is the sole manufacturer of the required items, and the requirement items are only available directly from them.

The associated North America Classification Systems (NAICS) Code is 339113 and the Small Business Size Standard is 800 employees.

THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTES. Interested parties may identify their interest and capability to respond to this requirement no later than 12:00 PM Mountain Standard Time, Thursday, December 19, 2024. Information received in response to this notice must clearly demonstrate the capability of meeting the Government s need as stated above. Include any relevant information (specifications, cut sheets, brochures, capability statement, etc.) confirming the ability to supply the products and/or any services outlined in this notice. Responses to this notice are to be sent to thaddeus.gray@va.gov.

A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. The Government is not responsible for any potential costs incurred from interested parties desiring to respond to this notice.

Files

File Type Posted
36C25925Q0100.docx DOCX document

Notice history

Notice Type Posted
6515--Actionable-S1 | 554 | New Consignment | Edwards Lifesciences TAVR Heart Valves (VA-24-00068478) Award Award Notice
This notice Latest special notice Special Notice

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