SSJ Edwards SAPIEN TAVR Valves Redacted.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 1 of 2

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 26C244-23-AP-0526

1. Contracting Activity: Department of Veterans Affairs, NCO4, VISN 4, James E Van Zandt Medical Center, 2907 Pleasant Valley Blvd., Altoona, PA 16602. Purchase Request: 646-23-1-230-1174

2. Brief description of supplies, required and the intended use, and estimated amount:

The Pittsburgh VA has a new requirement for the procurement of multiple Edwards Life Science SAPIEN Trans Aortic Valve Replacement (TAVR) Valves in the cardiology section of Medicine Service Line. These supplies are needed for New HyBrid Room Activation. This device is required for TAVR Procedures, Trans Aortic Valve Replacement, which is a Percutaneous Interventional Procedure which greatly reduces the need for Open Chest/Open Heart Surgery resulting in multiple patient complications and death.

The following items are required:

Item Qty

23 mm Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (THV) with Commander System S3UCM223A 2ea 26 mm Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (THV) with Commander System S3UCM226A 2ea 29 mm Edwards SAPIEN 3 Transcatheter Heart Valve (THV) with Commander System 9600CM29A 2ea

Estimated total contract value

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

A patients anatomy dictates need for either a self-expanding TAVR valve or balloon-expandable TAVR valve. The Edwards valve is the only balloon-expandable valve on the market. This type of valve is positioned and expands when a balloon on a catheter’s tip is inflated. This type of valve is positioned and expands when the doctor removes a thin, flexible tube and deploys the new valve.

The SAPIEN 3 Ultra valve facilitates future coronary access with low frame height, intra-annular leaflets, and large open cells. The Edwards Commander delivery system balloon-expandable platform delivers stable, precise deployment as well as dual articulation for tracking and coaxiality with 99% deployment accuracy in the intended location.

4. Description of market research conducted and results or statement why it was not conducted:

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 2 of 2

As part of market research conducted by the Contract Specialist by issuing a Sources Sought to SAM.

Two (2) responses were received one (1) SDVOSB and one (1) Large Business who is the manufacturer.

Edwards Lifesciences (Original Equipment Manufacturer) (Large Business) is the manufacturer of Edwards SAPIEN 3 Ultra Transcatheter Heart Valves required by the VA Pittsburgh Healthcare System. An informal email was sent to Edwards requesting a list of authorized distributors. A representative from Edwards, Liz Lewis, and stated All Edwards Transthoracic Heart Valves products must be purchased directly from Edwards through their field teams.

Sources Sought 36C24423Q0211 was posted to SAM from 12/07/2022 to 12/14/2022. The posting yielded two (2) responses, SDVOSB and Large Business concerns.

A search of VIP on 12/15/2022 with key words “Edwards Lifesciences” and “339112” yielded one (1) SDVOSB, 1st American Medical Distributors.

This is a Brand Name Justification in accordance with 11.105(a)(1) Items Peculiar to One Manufacturer. This justification shall be posted to Contracting Opportunities with the solication in accordance with 11.105(3).

Based on the above Market Research and the Non-manufacturer Rule, the CS anticipates a Brand Name Only Unrestricted solicitation to be posted to SAM.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Jennifer Beiswenger, NCO4, Commodities 2 Andrew Taylor, NCO4, Commodities 2 Contract Specialist Contracting Officer

Jennifer L.

Beiswenger 1504228

Digitally signed by Jennifer L.

Beiswenger 1504228 Date: 2022.12.16 09:15:17 -05'00'