ON-X HEART VALVE IDIQ WITH CONSIGNMENT

This is a notice of intent to sole source a contract under the authority of FAR 13.106-1(b)(2), only one source being available to meet the Government’s need.  The contract is estimated for final completion by 11/30/2030.

The North American Industrial Classification System (NAICS) code for this procurement is 339113, Surgical Appliance and Supplies Manufacturing, with a small business size standard of 800 employees.  The FSC/PSC is 6515 – Medical and Surgical Instruments, Equipment, and Supplies.

The Department of Veterans Affairs intends to solicit a firm fixed price Indefinite Delivery Indefinite Quantity contract for On-X Heart Valves and Prostheses to Artivion, Inc., 1655 ROBERTS BLVD NW, KENNESAW, GA 30144-3632. There are no other sources that will satisfy agency requirements for the necessary items.

Market research has confirmed there are no authorized distributors for On-X aortic and mitral hear valves as well as On-X aortic prostheses.  Sale of the necessary implants are made only through the Original Equipment Manufacturer (OEM), Artivion, Inc.

Any responsible source that feels it is capable in performing this requirement may submit a quote for the above listed items and describe and/or submit documentation to support your capabilities.  The response will be considered by the agency.  If you are not the Original Equipment Manufacturer (OEM), you must submit an authorized distributor letter, specific to the distribution to the Department of Veterans Affairs or U.S. Government, signed by the OEM.  Responses should be submitted to Leah Smith at leah.smith@va.gov no later than Friday, October 10, 2025, at 11:00 AM Pacific Time to be considered. The Government will not pay for information submitted. Any responses received will only be considered for the purposes of determining whether to conduct a competitive procurement in lieu of sole source contract described in this notice, and such determination shall be made at the sole discretion of the Government. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the requirement. If no responses are received, the government will proceed with the Sole Source acquisition.