6515--Notice of Intent to Sole Source - Affera Mapping Ablation Medtronic USA, INC.

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. for the procurement of Medtronic Affera Catheters for the Pulmonary Embolism Team in the Cardiology Cath Lab. The catheters are an FDA-approved, all-in-one, high-density catheter technology designed to treat cardiac arrhythmias, particularly atrial fibrillation (AFib). The proposed sole source is to MEDTRONIC USA, INC. because Medtronic is the manufacturer of these catheters and the Sphere-9 Catheters are the only catheters currently available which do mapping, catheter, pulsed field ablation, and radio frequency ablation in one catheter. Key items to be procured include: • Affera Integrated Mapping System • HexaGen RF Generator • HexaFlow Irrigation Pump • HexaPulse PF Generator • System Cart • Medtronic Sphere 9 Catheters • Tubing Sets • Catheter Extension Cables • Impedance Localization Patch Kits • Standard Service Agreement The agency is seeking an IDIQ contract for the consumables.