6515--Consignment Agreement - Prosthetic Valves - Ann Arbor

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:

INSPIRIS RESILIA AORTIC VALVE (19MM, 21MM, 23MM, 25MM, 27MM, 29 MM)

PHYSIO MITRAL ANNULOPLASTY RING (24M, 26M, 28M, 30M, 32M, 34M, 36M, 38M, 40M)

COSGROVE ANNULOPLASTY SYSTEM (26MM, 28MM, 30MM, 32MM, 34MM, 36MM, 38MM)

MC3 TRICUSPID ANNULOPLASTY SYSTEM (26T, 28T, 30T, 32T, 34T, 36T)

MITRIS RESILIA MITRAL VALVE (25MM, 27MM, 29MM, 31MM, 33MM)

MAGNA MITRAL EASE PERICARDIAL VALVE WITH THERMAFIX (25MM, 27MM, 29MM, 31MM, 33MM)

In the marketplace for implantable heart valves there are two main types: mechanical and

bioprosthetic. For the majority of patients, age is the critical factor, with bioprosthetic being

recommended for patients over the age of 65. While each patient is given individual attention and care when choosing which valve replacement option is best for them, Edwards Lifesciences has typically been the most requested bioprosthetic valve by both patients and surgeons. Edwards Lifesciences also has a more robust product line to include mitral valves, tricuspid annuloplasty systems, annuloplasty rings, etc., which have also been requested by our physicians. The Edwards Lifesciences product storage is also recommended vs other competitors, where their ability for dry storage tends to be optimal compared to the cold storage of most other bioprosthetic heart valves. Edwards Lifesciences LLC heart valves are specific because the INSPIRIS Magna Ease uses the INSPIRIS design, it is an internally mounted pericardial tissue using 3 leaflets that are each individually cut. They have a 2 stage anti-calcification process addressing both phospholipids and residual glutaraldehyde. The 7300TFX uses a dual stage anti-calcificationepic. The 4900 features a specific 3d semi-rigid design that has been specifically designed for the Tricuspid position. The 4600 Cosgrove comes pre sized and does not need to be cut and it can be used in Mitral and Tricuspid position. The Physio uses 4 individual elgiloy bands to preserve natural annular movement and shape of the annulus. Consignment contracts allow the VA to keep several of these short shelf-life items in the facility without having to buy them until they are used. The items requested meet the strict requirements of quality and functionality for the procedures for which they are chosen. The

supplies are selected based on their specific use during procedures. Edwards Lifesciences, LLC is the only firm capable of providing the supplies. The VA Ann Arbor Healthcare System has several different consignment instruments put in place for flexibility and added variety of sizes and models that allow the VA physicians the ability to make the best match possible of implantable device to the veteran s health need.

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 Monday, July 14, 2025.

Kellie Konopinski

Contracting Officer

(734) 222-4330

Kellie.Konopinski@va.gov