Edwards Lifesciences LLC

Edwards Lifesciences LLC, a for-profit limited liability company and self-certified small disadvantaged business, manufactures and supplies transcatheter aortic valve replacement (TAVR) systems, surgical heart valves, annuloplasty systems, and related cardiovascular implants to the federal government as a prime contractor, operating overwhelmingly on a full-and-open, non-set-aside basis. The company is headquartered in Irvine, California, and is a wholly-owned subsidiary of Edwards Lifesciences Corporation; it competes across NAICS 339113 (Surgical Appliance and Supplies Manufacturing) and PSC Medical and Surgical Instruments, Equipment, and Supplies. Edwards Lifesciences LLC operates as the sole manufacturer of specified cardiac implant products for its customer base, with nearly all awards issued by the Department of Veterans Affairs across multiple Veterans Integrated Service Networks on a brand-name, sole-source procurement model.

Edwards Lifesciences LLC's federal footprint is nearly entirely concentrated within the VA healthcare system. Over the past five years, the vendor has received 18,277 prime contract awards with a combined potential value of $448.2 million, of which $312 million has been obligated. The top five VISNs account for 37 percent of award count: VISN 8 (2,040 awards, $51.3 million potential value), VISN 23 (1,388 awards, $36.3 million), VISN 21 (1,207 awards, $60.4 million), VISN 1 (1,135 awards, $23.5 million), and VISN 17 (1,026 awards, $29.3 million). By dollar magnitude, the top five funders represent 47 percent of combined potential value, led by VISN 21 ($60.4 million), VISN 8 ($51.3 million), VISN 23 ($36.3 million), VISN 22 ($32.7 million), and VISN 15 ($30.2 million). Recent award velocity has averaged 600 to 775 awards annually from 2022 through 2025, declining to 421 awards in calendar year 2026 as of mid-October. Individual purchase orders and delivery orders typically range from $16,000 to $68,000, with larger consignment restocks reaching $102,000 to $374,000 per order. Procurement authority spans 40 distinct federal agencies, but 37 percent of awards by count and 47 percent by dollar value flow through the named five VISNs.

Edwards Lifesciences LLC operates under multiple single-award indefinite-delivery consignment contracts with the VA. Two named IDCs anchor the recent contract footprint: a $917,000 five-year IDC with VISN 12 (William S. Middleton VA Hospital, Madison, Wisconsin, effective through September 20, 2031) and a separate $1 ceiling IDC with VISN 12 (effective through March 31, 2031) for structural heart valves and surgical implants on consignment. Additional consignment IDCs are referenced in the award narrative but not detailed separately — the source indicates five-year IDCs with VISN 21 valued at $6.5 million (through December 31, 2030) and VISN 15 valued at $950,000 (through October 19, 2030). Task orders and purchase orders are issued under these framework vehicles at individual sites including VA Palo Alto Health Care System, William S. Middleton VA Hospital, and subordinate medical centers across the network. The consignment model allows VISNs to maintain optimized inventory of Edwards Lifesciences' specialized cardiac devices and procure them on an as-needed basis. Representative recent procurements include a $374,000 delivery order for SAPIEN 3 RESILIA heart valves issued by VISN 17 in June 2026 (scheduled completion May 31, 2030), a $204,300 purchase order for HemoSphere Alta Smart Recovery Bundle hemodynamic monitoring equipment issued by VISN 8 in September 2026, and multiple $32,500 to $68,000 purchase orders for specific valve models (S3 Ultra Valve, Resilia Transcatheter Heart Valve, TAVR, PASCAL implant systems, and Evoque bundles) issued across all five top-volume VISNs on firm fixed-price terms.

The vendor's procurement posture is almost entirely full-and-open competitive without set-asides — all recent awards from the source carry "No Set-Aside Used" designation, despite Edwards Lifesciences LLC's self-certified small disadvantaged business status. Procurements are authorized under 41 U.S.C. 3304(a)(5) and 38 U.S.C. 8123 as sole-source awards, with Edwards Lifesciences determined to be the sole manufacturer capable of meeting brand-name and product-specific requirements for prosthetic surgical heart valves and related cardiovascular implants. The vendor's subcontractor footprint is negligible — the source reports 14 sub-awards (0.07 percent of total) across 18,277 prime awards, including a single identified sub-award to MEI Mail Services Inc. in January 2024. Edwards Lifesciences LLC does not appear on major government-wide acquisition vehicles (GWACs) or multi-agency IDIQs; its vehicle strategy relies on VA-specific single-award consignment contracts and direct purchase order authority under existing indefinite delivery agreements.

Category concentration is acute: 50.8 percent of awards carry NAICS 339113 (Surgical Appliance and Supplies Manufacturing), with an additional 17.8 percent under NAICS 339112 (Surgical and Medical Instrument Manufacturing). Over 96 percent of awards are coded to PSC Medical and Surgical Instruments, Equipment, and Supplies. The award portfolio exhibits stable annual delivery (600 to 775 awards per year from 2022–2025) but shows a slowdown in 2026. Within the next twenty-four months, 132 awards with combined potential value of $7.5 million face completion and recompete exposure, representing less than 2 percent of the total active portfolio. Edwards Lifesciences LLC's parent, Edwards Lifesciences Corporation, is a global cardiovascular medical device manufacturer; the source identifies one named subsidiary, Enablecv, Inc., a for-profit manufacturer of goods. The vendor's role in federal contracting is singular: it serves as the VA's primary, sole-source supplier of transcatheter and surgical heart valve systems and related cardiac implants across the healthcare network, with no significant involvement in defense, civilian agency IT, or non-healthcare federal programs.