36C25525D0045_2.pdf

This is a Justification and Approval (J&A) Notice for a sole source procurement of Edwards heart valves by the Department of Veterans Affairs (VA) at the Harry S. Truman Memorial Veterans' Hospital. The contract (36C25525D0045) is an Indefinite Delivery/Indefinite Quantity (IDIQ) agreement with Edwards Lifesciences LLC for various transcatheter heart valve products, including SAPIEN 3 and RESILIA models in multiple sizes, with a Commander or Certitude system. The total estimated contract value is $4,261,359.80, spanning a base period and four option years from 04/01/2025 to 03/31/2030.

The procurement is justified as a sole source due to Edwards Lifesciences' proprietary heart valve technology, which offers unique features such as precise sizing, safety features for stent folding, novel tissue preservation techniques, and expandable rings for future valve replacement. Market research confirmed Edwards Lifesciences has no authorized distributors, and no other vendors were found capable of providing equivalent heart valves. The VA will conduct annual market research to verify no alternative sources emerge, with normal delivery within 48 hours and urgent delivery available with advance notice.