6515--Intent to Sole Source Edwards Lifesciences Consignmentview on SAM.gov

Intent to Sole Source The Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Network Contracting Office (NCO) 12 in Milwaukee, WI, intends to award a firm fixed price contract on a sole source basis to: Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614-5688 This action is for the continued provision of specialized cardiovascular surgical implants including aortic valves, mitral valves, annuloplasty rings, and annuloplasty bands under a consignment agreement. Under this arrangement, Edwards Lifesciences will maintain an on site inventory at the medical center, and the Government will only be invoiced for items actually implanted during surgical procedures. The Edward Hines Jr. VA Medical Center requires uninterrupted access to these cardiovascular implants, which are patented, proprietary devices manufactured exclusively by Edwards Lifesciences. These products such as surgical aortic and mitral valves, mitral annuloplasty rings, annuloplasty bands, and transcatheter valves are not available from any other source and cannot be replicated or supplied by alternate manufacturers. Due to the nature of cardiac surgery, it is not possible to predetermine which implant type or size will be required prior to the procedure. Maintaining a consignment stock of multiple valve and annuloplasty system sizes ensures that surgeons have immediate access to the correct device during both scheduled and emergent cases. Edwards Lifesciences implants incorporate unique anatomical designs, proprietary RESILIA tissue technology, and specialized construction that align with Hines VAMC s established surgical techniques, validated procedures, and clinical protocols. These devices are not interchangeable with products from other manufacturers. Substituting alternative devices would require extensive surgeon retraining, revalidation of surgical workflows, and revisions to clinical practice guidelines resulting in substantial and unrecoverable duplication of cost, as well as unacceptable delays to patient care. This action is authorized under 38 U.S.C. 8123, as implemented by VHA Directive 1081.01(1), which permits the VHA to procure surgical implants including cardiovascular devices without regard to any other provision of law, such as the FAR or VAAR. This authority allows VA medical facilities to utilize expeditious and clinically driven acquisition procedures, including consignment arrangements, to ensure rapid access to patient specific implantable devices. If your company believes it can meet this requirement, you may submit a written capability response to Stacy.Massey@va.gov no later than 5:00 PM EST on July 17, 2026. Responses must include sufficient detail to demonstrate the ability to supply all required patented cardiovascular implants with equivalent clinical functionality and availability. Please note: Email responses only; phone calls will not be accepted. Responses must clearly demonstrate how competition would benefit the Governm…