6515--(PROS) 660 B+4 Consignment | Edwards Life Science | IMPLANTS | (VA-25-00035152)

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 KONECT RESILIA Aortic Valved Conduit, INSPIRIS RESILIA Aortic Valves, MC3 Tricuspid Annuloplasty Rings, Cosgrove Annuloplasty System, Physio II Mitral Annuloplasty Ring and Magna Mitral Ease Pericardial Valve for patients on a blank purchase basis. The anticipated term of the blanket purchase agreement contract is five (5) years.

Consignment Items:

Model Number

Description

PAR Level

11060A21

KONECT RESILIA Aortic Valved Conduit, 21MM

1

11060A23

KONECT RESILIA Aortic Valved Conduit, 23MM

1

11060A25

KONECT RESILIA Aortic Valved Conduit, 25MM

1

11060A27

KONECT RESILIA Aortic Valved Conduit, 27MM

1

11060A29

KONECT RESILIA Aortic Valved Conduit, 29MM

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

2

460026MM

Cosgrove Annuloplasty System 26MM

1

460028MM

Cosgrove Annuloplasty System 28MM

1

460030MM

Cosgrove Annuloplasty System 30MM

1

460032MM

Cosgrove Annuloplasty System 32MM

1

460034MM

Cosgrove Annuloplasty System 34MM

1

460036MM

Cosgrove Annuloplasty System 36MM

1

460038MM

Cosgrove Annuloplasty System 38MM

1

4900T26

MC3 Tricuspid Annuloplasty System 26T

1

4900T28

MC3 Tricuspid Annuloplasty System 28T

1

4900T30

MC3 Tricuspid Annuloplasty System 30T

1

4900T32

MC3 Tricuspid Annuloplasty System 32T

1

4900T34

MC3 Tricuspid Annuloplasty System 34T

1

4900T36

MC3 Tricuspid Annuloplasty System 36T

1

5200M24

Physio II Mitral Annuloplasty Ring 24M

1

5200M26

Physio II Mitral Annuloplasty Ring 26M

1

5200M28

Physio II Mitral Annuloplasty Ring 28M

1

5200M30

Physio II Mitral Annuloplasty Ring 30M

1

5200M32

Physio II Mitral Annuloplasty Ring 32M

1

5200M34

Physio II Mitral Annuloplasty Ring 34M

1

5200M36

Physio II Mitral Annuloplasty Ring 36M

1

5200M38

Physio II Mitral Annuloplasty Ring 38M

1

5200M40

Physio II Mitral Annuloplasty Ring 40M

1

7300TFX25

Magna Mitral Ease Pericardial Valve with ThermaFix 25MM

1

7300TFX27

Magna Mitral Ease Pericardial Valve with ThermaFix 27MM

1

7300TFX29

Magna Mitral Ease Pericardial Valve with ThermaFix 29MM

1

7300TFX31

Magna Mitral Ease Pericardial Valve with ThermaFix 31MM

1

7300TFX33

Magna Mitral Ease Pericardial Valve with ThermaFix 33MM

1

The projected period of performance: May 23, 2025 May 22, 2030.

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, Monday, May 16, 2025. 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.