6515--Notice of Intent to Sole Source - Affera Mapping Ablation Medtronic USA, INC.
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Department of Veterans Affairs (VA), specifically the Network Contracting Office 16 (NCO 16), has issued a Special Notice of intent to award a sole source firm-fixed priced purchase order to MEDTRONIC USA INC. for Medtronic Affera Catheters and associated equipment. These items are for the Pulmonary Embolism Team in the Cardiology Cath Lab at MEDVAMC, used for treating cardiac arrhythmias, particularly atrial fibrillation (AFib).
Scope of Work
The procurement includes the Medtronic Affera Catheters (Sphere-9), which are FDA-approved, all-in-one, high-density catheter technology capable of both Pulsed Field Ablation (PFA) and Radiofrequency (RF) energy delivery. The Sphere-9 catheters are noted for faster, safer, and more precise mapping and ablation. The requirement is for an Indefinite Delivery, Indefinite Quantity (IDIQ) contract for consumables.
Specific items to be procured include:
- Affera™ Integrated Mapping System (1)
- HexaGen RF Generator (1)
- HexaFlow Irrigation Pump (1)
- HexaPulse PF Generator (1)
- System Cart (1)
- Medtronic Sphere 9 Catheters (133)
- Tubing Sets (33)
- Catheter Extension Cables (133)
- Impedance Localization Patch Kits (33)
- Standard Service Agreement (1)
Contract & Timeline
- Type: Firm-Fixed Priced Purchase Order (intended sole source)
- Anticipated Authority: 41 U.S.C. 3304(a)(1) and FAR 6.103-1 (only one responsible source)
- Set-Aside: None (Sole Source)
- Published: March 17, 2026
- Response Due: March 24, 2026, 12:00 PM Central Time
Evaluation
This notice is not a request for quotations or proposals, and no contract will be awarded based solely on responses. However, all responsible sources may submit a capability statement, proposal, or quotation. These submissions will be used to determine if a comparable and more advantageous source is available to the government. Authorization letters must be provided if applicable. If no affirmative written response is received within 5 business days from the publication date (March 17, 2026), a contract will be issued to MEDTRONIC USA, INC. without further notice.
Additional Notes
Medtronic USA, Inc. is identified as the sole manufacturer of the Sphere-9 Catheters, which are currently the only catheters available that integrate mapping, catheter, pulsed field ablation, and radio frequency ablation into a single unit.