Justification and Approval_Redacted.pdf

Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 2 of 5 Revision: 02 Effective Date: 11/15/23 Acquisition ID#: __________________

5. Statutory Authority Permitting Other than Full and Open Competition:

(X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR

6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

6. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The prosthetic aortic implant produced by Artivion, Inc. is a proprietary item. These specialized products differ between manufacturers and are typically unique to each company.

Despite potential similarities, each manufacturer offers their own distinct designs and features for aortic implants. Due to the unique nature of these products and the current market conditions, it is challenging for competitors to penetrate the market. The Government is focused on maintaining a strong and successful supply chain for prosthetic aortic implants.

Several studies have shown that the Artivion On-X valve offers favorable clinical outcomes, with low early and late mortality rates, and a reduced incidence of prosthetic valve-related complications. The valve is particularly well-suited for implantation in the aortic position, where it has demonstrated better long-term non-structural durability.

One of the key features of the Artivion On-X valve is its use of pure pyrolytic carbon, which is free of silicon. This advanced material, combined with a unique design that mimics the dimensions of a native valve, has resulted in improved strength, hemodynamics, and reduced risks of hemolysis and thrombogenicity. The valve's leaflets can open to 90 degrees, which allows for optimal blood flow.

Unlike older mechanical valves that contain small amounts of silicon, the pure carbon used in the Artivion On-X valve is stronger, more deformable, and tougher. This has allowed for the creation of a valve with superior performance and durability.

In clinical trials, the Artivion On-X valve has been shown to require less anticoagulation therapy than other mechanical valves, resulting in a significant reduction in bleeding events without an increase in thromboembolism. The valve is also designed to provide optimal hemodynamics, closely resembling those of a healthy human aortic valve.

The Artivion On-X prosthetic heart valve is indicated for use in both the aortic and mitral positions and has been shown to offer a survival benefit for recipients of mitral valve replacement.

In conclusion, the Artivion On-X Aortic and Mitral Heart Valves have demonstrated superior clinical outcomes, durability, hemodynamics, and reduced need for anticoagulation therapy compared to other mechanical heart valves. The valves have also shown survival benefits for patients undergoing mitral valve replacement procedures. Its unique design and advanced materials make it a preferred option for patients in need of valve replacement surgery.

VHAPG Part 806.3 OFOC Page 3 of 5 Revision: 02 Effective Date: 11/15/23 Acquisition ID#: __________________

Sole sourcing these valves is justified based on their unique features and benefits, including their advanced materials, innovative design, and superior performance outcomes. The reduction in anticoagulation therapy needed for patients receiving the Artivion On-X valves can lead to lower risks of bleeding and thromboembolism, making them a safer option for patients.

Overall, the On-X valves represent a significant advancement in prosthetic heart valve technology and offer improved quality of life for patients in need of valve replacement surgery. The data supporting their use and the unique features they offer make them a preferred choice for aortic and mitral valve replacement procedures. Sole sourcing the Artivion On-X Aortic and Mitral Heart Valves is therefore a logical and justifiable decision to ensure the best outcomes for patients undergoing heart valve replacement surgery.

Use of On-X valves will enable STLVA to provide the best of valves, with least risk to veterans.

7. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

The manufacturer, Artivion, Inc., was contacted to find if there were vendors for these heart valves. Artibion responded that they were the only source.

8. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The anticipated cost is considered fair and reasonable as market research was conducted of other heart valves, current price lists, and historical pricing. Before the exercise of each option year, market research will be conducted to see if these valves are available at a better price. No cost or price analysis is anticipated, including the requirements for certified cost or pricing data, technical evaluations, and audits (FAR 6.303-2(b)(7)), as this is a commercial item.

9. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Market research was conducted pursuant to FAR Part 10, VA Acquisition Regulation (VAAR) 810.001-70 Market Research Policy, and PPM 2016-05(Revised Aug 2019). This is a sole-source requirement to Artivion, Inc. These heart valves are proprietary to Artivon.

Argivion has no vendors.

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties.

Consideration was given to BAA/TAA/Exceptions to BAA (See FAR Part 25). On-X heart valves are manufactured in Austin, Texas, USA.

VHAPG Part 806.3 OFOC Page 4 of 5 Revision: 02 Effective Date: 11/15/23 Acquisition ID#: __________________

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

N/A

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

Artivion, Inc.

12. 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:

In order to foster competition for future acquisitions of these supplies, market research will be performed before exercising each option to find if these supplies could be provided at a better price or if a small business is available.