ON-X CONSIGNMENT JUSTIFICATION_Redacted.pdf

Simplified Acquisition Procedures for Certain Commercial Items Sole Source Justification

Effective Date: 02/01/2022 Page 2 of 5

On-X Aortic Prosthetic Heart Valve 21mm with Anatomic Sewing Ring

On-X Aortic Prosthetic Heart Valve 23mm with Anatomic Sewing Ring

On-X Aortic Prosthetic Heart Valve 25mm with Anatomic Sewing Ring

On-X Aortic Prosthetic Heart Valve 27/29mm with Anatomic Sewing Ring

On-X Mitral Prosthetic Heart Valve 25mm with Standard Sewing Ring

On-X Mitral Prosthetic Heart Valve 27/29mm with Standard Sewing Ring

On-X Mitral Prosthetic Heart Valve 31/33mm with Standard Sewing Ring

On-X Mitral Prosthetic Heart Valve 25/33mm with Conform-X Sewing Ring

On-X Ascending Aortic Prosthesis w/ Vascutek Gelweave Valsalva Graft 19mm

On-X Ascending Aortic Prosthesis w/ Vascutek Gelweave Valsalva Graft 21mm

On-X Ascending Aortic Prosthesis w/ Vascutek Gelweave Valsalva Graft 23mm

On-X Ascending Aortic Prosthesis w/ Vascutek Gelweave Valsalva Graft 25mm

On-X Ascending Aortic Prosthesis w/ Vascutek Gelweave Valsalva Graft 27/29mm

The estimated value of consigned quantities is . The estimated annual spend is with usage over the five-year period estimated as .

The contract ceiling is planned as .

Period of performance is planned as follows:

Ordering Period 1 : 11/01/2025 – 10/31/2026 Ordering Period 2 : 11/01/2026 – 10/31/2027 Ordering Period 3 : 11/01/2027 – 10/31/2028 Ordering Period 4 : 11/01/2028 – 10/31/2029 Ordering Period 5 : 11/01/2029 – 10/31/2030

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(x) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency

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( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services

( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the

Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

On-X, manufactured by large business Artivion, Inc., is a brand name implant selected as the preferred surgical implant by the Palo Alto Health Care System Surgical Service. Per VHA 1081.01(1) November 23, 2018, section 5 (i)(1), “Prescribing Specialty Clinicians have the authority to select which surgical implant is medically necessary”. The On-X valve is a newer generation mechanical bileaflet valve. Its key features include the use of pure pyrolytic carbon (devoid of silicon), a length-to-diameter ratio similar to a native valve, an inlet flared orifice, a leaflet opening up to 90 degrees, a shorter leaflet closing angle, a 2-point leaflet contact, and an actuated pivot. These features have translated into increased strength, improved valve hemodynamics, reduced hemolysis, and thrombogenicity. The On-X Prosthetic Heart Valve is recommended for replacing damaged or malfunctioning heart valves in the aortic and mitral positions. Produced and sold exclusively by Artivion, Inc., these valves are unique in design and function, setting them apart from other products on the market. The Government is focused on maintaining a reliable supply chain for these vital medical devices due to their exceptional materials, innovative design, and superior performance outcomes. With the On-X valves, patients may require less anticoagulation therapy, resulting in decreased risks of bleeding and thromboembolism.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: As these products are confirmed as available only through the manufacturer, no additional research was conducted to locate additional sources.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Quoted prices will be reviewed against prices previously paid by the government. Any price adjustments allowed through the inclusion FAR 52.216-2 Economic Price Adjustment clause will be deemed fair and reasonable prior to processing modification to adjust prices.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted to determine if the On-X items necessary for this requirement would be available under existing contracts. Supply Chain Master Catalog resulted in search for products beginning in ONX part number but confirmed as different items and a different manufacturer. NAC and GSA Advantage returned no results for the On-X branded items. A market research outreach to the OEM on 07/24/2025 confirmed there are no authorized distributors and that sales have

Effective Date: 02/01/2022 Page 4 of 5 occurred directly through Artivion, Inc. since their purchase of the On-X product line several years ago.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

There are no other facts.

10.Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Artivion, Inc., Large Business, L23KYFC21D68

11.A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: The agency will continue to conduct market research to identify opportunities for a competitive procurement or additional acceptable products in the future.

12.Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

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b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.