On-X Heart Valve IDIQ with Consignment

Amendment / Modification

• The due date for quote responses has been extended by seven (7) days.

• The new due date is October 10, 2025, at 11:00 AM Pacific Time.

• Item 11 of the solicitation (regarding the hour and date specified for receipt of offers) has been modified.

• The deadline for submitting quotes has been extended to October 10, 2025, at 11:00 AM Pacific Time.

Form / Attachment / Pricing Sheet

This document is a price list for various On-X prosthetic heart valves and ascending aortic prostheses. It details product codes, unit prices, consignment quantities, estimated annual quantities, and estimated quantities for five ordering periods.

• Products: Includes On-X Aortic Prosthetic Heart Valves (with different sewing rings), On-X Mitral Prosthetic Heart Valves, and On-X Ascending Aortic Prostheses.
• Product Codes: Specific codes are provided for each product variation (e.g., ONXAE-19, ONXM-25).
• Quantities: Consignment, Estimated Annual, and Estimated Ordering Period quantities are listed.
• Unit Price: This column is present but generally blank in the provided data, indicating potential for pricing to be determined or negotiated.
• Ordering Periods: Data is segmented across five distinct ordering periods.

This pricing sheet is crucial for bidders to understand the potential costs associated with the listed medical devices. While unit prices are largely unspecified, the estimated quantities across multiple ordering periods provide a basis for cost estimation and proposal development. Bidders should review this document to determine their pricing strategy and ensure they can meet the potential demand for these products.

Other / Unclassified

This document is a Sole Source Justification for a procurement under Simplified Acquisition Procedures for Certain Commercial Items, in accordance with FAR 13.5. It details the rationale for restricting competition for the acquisition of On-X Aortic and Mitral Prosthetic Heart Valves and Ascending Aortic Prosthesis with Vascutek Gelweave Valsalva Graft.

This justification is relevant to potential bidders as it explains why the procurement is being conducted as a sole source. It identifies the specific products required, the contracting activity, and the statutory authority for restricted competition. The document states that the On-X valves are unique, manufactured exclusively by Artivion, Inc., and selected by clinicians as medically necessary. Market research did not identify other sources or authorized distributors for these specific branded items. The agency intends to continue market research for future acquisitions to identify opportunities for competitive procurement.

• Procurement Type: Five-year Indefinite Delivery / Indefinite Quantity (IDIQ), fixed price contract with economic price adjustment.
• Products: Various On-X Aortic and Mitral Prosthetic Heart Valves and Ascending Aortic Prosthesis with Vascutek Gelweave Valsalva Graft.
• Contracting Activity: Department of Veterans Affairs, Network Contracting Office (21), Palo Alto VA Medical Center.
• Authority: FAR 13.5 Simplified Procedures for Certain Commercial Items, citing 41 U.S.C. § 1901 and FAR 13.106-1(b)(2) for restricting competition.
• Reason for Restriction: Only one responsible source and no other supplies or services will satisfy agency requirements.
• Period of Performance: Five ordering periods from 11/01/2025 to 10/31/2030.
• Manufacturer: Artivion, Inc. (large business).

Solicitation / RFP / RFQ

This solicitation is for an Indefinite Delivery, Indefinite Quantity (IDIQ) contract for On-X Heart Valves and Prostheses. The purpose is to ensure the VA Palo Alto Health Care System (VAPAHCS) has immediate access to these critical implants for emergent and scheduled cardiac procedures through a consignment model. This model allows the facility to stock items without upfront purchase, reducing waste and supporting timely patient care.

• Provide and maintain a consigned inventory of On-X Valves at VAPAHCS.

• Items must be state-of-the-art technology, with no planned obsolescence within the first year.

• Replacements for used items must be provided within 48 hours of order placement.

• Expiring inventory (less than 90 days sterility/expiration) must be removed and replaced at no cost to the Government.

• Defective or worn-out instruments must be replaced at no charge.

• Products must be stored in accordance with manufacturer's Instructions for Use (IFU) and clearly identified as consignment.

• Contract Type: Indefinite Delivery, Indefinite Quantity (IDIQ)

• Period of Performance: Five (5) years, from 11/1/2025 to 10/31/2030, with five ordering periods.

• Guaranteed Minimum Award: $25,000.00

• Maximum Aggregate Value: $350,000.00

• Offerors must submit quotes via email to leah.smith@va.gov by 10/03/2025, 11:00 AM PDT.

• Questions must be received via email two business days prior to the closing period.

• The solicitation is a FAR Part 13 sole source solicitation to Artivion, Inc.

• Evaluation will be based on price only.

• This is a sole source solicitation to Artivion, Inc.

• The Government reserves the right to cancel consignment at any time.

• The Government assumes no liability for consignment items until an order is placed.

• Economic price adjustments are allowable under the IDIQ and require written requests 60 days prior to the start of the next ordering period.