6515--Notice of Intent to Sole Source - Affera Mapping Ablation Medtronic USA, INC.
Closed Special Notice Posted
- Solicitation number
- 36C25626Q0522
- Agency
-
Veterans Integrated Service Network 16
Veterans Health Administration, Department of Veterans Affairs
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 339112 Surgical and Medical Instrument Manufacturing
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Veterans Affairs Veterans Health Administration, Veterans Integrated Service Network 16, published this Special Notice on March 17, 2026, announcing its intent to award a sole-source contract to Medtronic USA, Inc. for cardiac ablation equipment and consumables. The Medical Center at the VA (MEDVAMC) seeks to procure the Medtronic Affera Mapping Ablation system for use by the Pulmonary Embolism Team in its Cardiology Catheterization Lab. This procurement falls under PSC code 6515 (Medical and Surgical Instruments, Equipment, and Supplies) and is categorized under NAICS 339112 (Surgical and Medical Instrument Manufacturing). The sole-source justification centers on the Sphere-9 Catheter's unique capabilities as the only currently available device integrating mapping, catheter placement, pulsed field ablation, and radiofrequency ablation functions. The contract will be awarded on a firm-fixed-price basis.
The procurement includes one Affera Integrated Mapping System, one HexaGen RF Generator, one HexaFlow Irrigation Pump, one HexaPulse PF Generator, one System Cart, 133 Medtronic Sphere 9 Catheters, consumable supplies including tubing sets and extension cables, and a Standard Service Agreement. Interested parties must submit capability statements, proposals, or quotations to Eugene Jackson at VA Network Contracting Office 16 (Eugene.Jackson2@va.gov) by 12:00 PM Central Time on March 24, 2026, with submissions used to determine whether a comparable source exists and would be more advantageous to the government. While all responsible sources may submit documentation, the VA will issue the contract to Medtronic without further notice if no affirmative written response is received within five business days of publication. This Special Notice is not a formal request for quotations or proposals, and no contract award will be made based solely on responses received. The solicitation number is 36C25626Q0522.
Notice text
Special Notice – Notice of Intent to Award a Sole Source Procurement
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
Files
| File | Type | Posted |
|---|---|---|
| 36C25626Q0522.pdf |
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