On-X Heart Valve IDIQ with Consignment

This government file details various On-X brand prosthetic heart valves, including aortic and mitral types, with different sewing ring configurations (Standard, Conform-X®, Anatomic) and sizes ranging from 19mm to 33mm. It also lists On-X Ascending Aortic Prostheses with Vascutek Gelweave Valsalva Grafts. The document appears to be a pricing or procurement schedule, indicating product codes, unit prices, and consignment quantities for each item across five estimated ordering periods. All listed unit prices and quantities are uniformly zero, suggesting this document might be a template, a placeholder, or a record of items with no current estimated cost or quantity for the specified periods.

This government solicitation, 36C26126Q0012, is for an Indefinite Delivery, Indefinite Quantity (IDIQ) contract with Artivion, Inc. to provide On-X Heart Valves and Prostheses to the VA Palo Alto Health Care System (VAPAHCS). The agreement is a consignment model, ensuring immediate access to critical implants for cardiac procedures without upfront purchase, reducing waste, and supporting clinical readiness. The contract has a guaranteed minimum award of $25,000.00 and a maximum aggregate value of $350,000.00 over a five-year period (November 1, 2025, to October 31, 2030). Key terms include maintaining state-of-the-art technology, quarterly inventory checks, replacement of used items within 48 hours, and specific procedures for product expiration, removal, or recall. Payment will be made by Government Purchase Card, and invoices must include detailed information and be submitted within five days of the charge. The solicitation is a sole-source acquisition under FAR Part 13, with specific clauses incorporated by reference, addressing aspects like economic price adjustment, order limitations, and various federal regulations.

This government file is a Sole Source Justification for the procurement of On-X Aortic and Mitral Prosthetic Heart Valves, and On-X Ascending Aortic Prostheses with Vascutek Gelweave Valsalva Grafts. The Palo Alto Health Care System Surgical Service has selected these Artivion, Inc. manufactured implants as the preferred surgical implant due to their unique design, materials, and performance benefits, including reduced anticoagulation therapy for patients. The procurement is justified under FAR 13.5 Simplified Procedures for Certain Commercial Items, specifically citing "Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements." Market research confirmed that Artivion, Inc. is the exclusive manufacturer with no authorized distributors. The contract covers five ordering periods from November 2025 to October 2030. The agency commits to ongoing market research to identify future competitive opportunities.

This document is an amendment to a solicitation/modification of a contract issued by the Department of Veterans Affairs, Network Contracting Office 21, for the VA Southern Nevada Healthcare System. The main purpose of this amendment, numbered 0001 with an effective date of 10-02-2025, is to extend the deadline for quote responses. The hour and date for receipt of offers have been extended by seven days, from October 3, 2025, to October 10, 2025, at 11:00 AM Pacific Daylight Time. All other terms and conditions of the original solicitation/contract remain unchanged and in full force and effect. This modification, signed by David Alvarez, Contracting Officer, ensures that potential offerors have additional time to submit their proposals.