6515--Notice of Intent to Sole Source - Edwards Lifesciences Heart Valves

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 including MITRIS RESILIA Mitral Valves, INSPIRIS RESILIA Aortic Valves, MC3 Tricuspid Annuloplasty Rings, and Carpentier-Edwards Physio II Annuloplasty Rings for patients on a consignment basis. The anticipated term of the requirements contract is five (5) years.

Consignment Items:

Part Number

Description

Quantity

11400M25

MITRIS RESILIA Mitral Valve, Size 25

2

11400M27

MITRIS RESILIA Mitral Valve, Size 27

2

11400M29

MITRIS RESILIA Mitral Valve, Size 29

2

11400M31

MITRIS RESILIA Mitral Valve, Size 31

2

11400M33

MITRIS RESILIA Mitral Valve, Size 33

1

11500A19

INSPIRIS RESILIA Aortic Valve 19mm

2

11500A21

INSPIRIS RESILIA Aortic Valve 21mm

2

11500A23

INSPIRIS RESILIA Aortic Valve 23mm

2

11500A25

INSPIRIS RESILIA Aortic Valve 25mm

2

11500A27

INSPIRIS RESILIA Aortic Valve 27mm

2

11500A29

INSPIRIS RESILIA Aortic Valve 29mm

1

4900T28

MC3 Tricuspid Annuloplasty Ring 28mm

1

4900T30

MC3 Tricuspid Annuloplasty Ring 30mm

1

4900T32

MC3 Tricuspid Annuloplasty Ring 32mm

1

4900T34

MC3 Tricuspid Annuloplasty Ring 34mm

1

4900T36

MC3 Tricuspid Annuloplasty Ring 36mm

1

5200M26

Carpentier-Edwards Physio II Annuloplasty Ring 26mm

2

5200M28

Carpentier-Edwards Physio II Annuloplasty Ring 28mm

2

5200M30

Carpentier-Edwards Physio II Annuloplasty Ring 30mm

2

5200M32

Carpentier-Edwards Physio II Annuloplasty Ring 32mm

2

5200M34

Carpentier-Edwards Physio II Annuloplasty Ring 34mm

2

5200M36

Carpentier-Edwards Physio II Annuloplasty Ring 36mm

2

5200M38

Carpentier-Edwards Physio II Annuloplasty Ring 38mm

2

The projected period of performance: December 15, 2024 December 14, 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 10:00 AM Mountain Standard Time, Monday, November 25, 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 Noaa.Lanotte@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.