Notice of Intent to Sole Source - Affera Mapping Ablation Medtronic USA, INC.

MEDVAMC is seeking to procure Medtronic Affera Catheters for the Pulmonary Embolism Team in the Cardiology Cath Lab. This generator and catheters are an FDA-approved, all-in-one, high-density catheter technology designed to treat cardiac arrhythmias, particularly atrial fibrillation (AFib). It uses the Sphere-9 catheter to deliver both Pulsed Field Ablation (PFA) and Radiofrequency (RF) energy, offering faster procedures and a 9mm flexible tip for safer, more precise, and efficient mapping and ablation.  Cardiology is requesting an IDIQ contract for the consumables. The Department of Veterans Affairs, Veterans Health Administration, Network Contracting Office 16, intends to award a firm-fixed priced purchase order to MEDTRONIC USA INC. at 710 Medtronic PKWY, Minneapolis, MN 55432, for the procurement of the following items: REF # Description QTY AFR-00016 Affera Integrated Mapping System 1 AFR-00004 HexaGen RF Generator 1 AFR-00005 HexaFlow Irrigation Pump 1 AFR-00008 HexaPulse PF Generator 1 AFR-00013 System Cart 1   Medtronic Sphere 9 Catheters 133   Tubing Sets 33   Catheter Extension Cables 133   Impedance Localization Patch Kits 33   Standard Service Agreement 1 The proposed sole source is to MEDTRONIC USA, INC. Medtronic is the manufacturer of these catheters. The Sphere-9 Catheters are the only catheters currently available which do mapping, catheter, pulsed field ablation, and radio frequency ablation in one catheter. This notice is not to be considered a request for quotations or proposals. No contract will be awarded based on offers received in response to this notice; however, all responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. Proposals or offers received will be used to determine if a comparable source is available and more advantageous to the government. Please provide authorization letters in response if applicable. If no affirmative written response is received within 5 business days from the publication of this notice, a contract or order will be issued to MEDTRONIC USA, INC. without any further notice. All submissions shall but submitted electronically via email to the contracting POC Eugene Jackson at Eugene.Jackson2@va.gov no later than 12:00pm 24 MAR 2026. No other submission methods will be considered. The anticipated statutory authority permitting other than full and open competition for the requirement is 41 U.S.C. 3304(a)(1), as implemented by FAR 6.103-1, only one responsible source and no other supplies or services will satisfy agency requirements.