36C10X26R0028.docx
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- 6515--Notice of Intent to Sole Source NX EQ Cryotherapy Systems: Tissue Ablation – Cardiac
- Solicitation number
- 36C10X26R0028
About this file
This is a Presolicitation Notice for a sole source procurement by the Department of Veterans Affairs (VA) Strategic Acquisition Center. The VA intends to award a firm fixed price requirements contract to Medtronic USA, Inc., located at 200 Medtronic Drive, Lafayette, CO 80026, for the procurement of the Medtronic Nitron CryoConsole Cardiac Cryoablation System, associated cryoballoon and focal catheters, installation services, clinical and technical training, and OEM preventive maintenance and repair services. The solicitation number is 36C10X26R0028, with a response date of May 8, 2026, at 10:00 AM Eastern Time. The contracting office is located in Frederick, Maryland (ZIP code 21703), with Anthony Zibolski serving as the Contracting Officer and Michael Andrews as the Contract Specialist.
The VA requires an FDA-cleared, electrophysiology lab integrated cardiac cryoablation platform capable of performing both pulmonary vein isolation using cryoballoon catheters and focal cryoablation using OEM validated catheters on a single console. The system must include a cart-based, closed-loop nitrous oxide cryogen delivery console with real-time pressure and temperature monitoring, automated safety interlocks, EP lab workflow integration, and enterprise-level OEM lifecycle service coverage. This procurement supports enterprise-wide electrophysiology laboratory cardiac cryoablation capabilities across participating VA medical centers nationwide. The applicable NAICS code is 339112 (Surgical and Medical Instrument Manufacturing) with a 1,000-employee size standard, and the Product Service Code is 6515 (Medical and Surgical Instruments, Equipment, and Supplies). The VA maintains that Medtronic's Nitron CryoConsole, Arctic Front cryoballoon catheters, and Freezor focal catheters constitute the only FDA-approved, OEM-validated EP lab cryoablation ecosystem capable of meeting the government's minimum requirements. Interested parties may submit capability statements demonstrating their ability to meet all minimum requirements.
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Presolicitation Notice
| SUBJECT* |
| Notice of Intent to Sole Source NX EQ Cryotherapy Systems: Tissue Ablation – Cardiac |
GENERAL INFORMATION
| CONTRACTING OFFICE’S ZIP CODE* |
| 21703 |
| SOLICITATION NUMBER* |
| 36C10X26R0028 |
| RESPONSE DATE/TIME/ZONE |
| 05-08-2026 10:00 EASTERN TIME, NEW YORK, USA |
| ARCHIVE |
| 0 DAYS AFTER THE RESPONSE DATE |
SET-ASIDE
| PRODUCT SERVICE CODE* |
| 6515 |
| NAICS CODE* |
| 339112 |
| PLACE OF PERFORMANCE |
| Nationwide |
POSTAL CODE
COUNTRY
CONTACT INFORMATION
| CONTRACTING OFFICE ADDRESS |
| Strategic Acquisition Center - Frederick |
Department of Veterans Affairs
5202 Presidents Court, Suite 103 Frederick MD 21703
POINT OF CONTACT*
Contracting Officer Anthony Zibolski Anthony.Zibolski@va.gov Contract Specialist Michael Andrews Michael.Andrews6@va.gov
ADDITIONAL INFORMATION
AGENCY’S URL
URL DESCRIPTION
AGENCY CONTACT’S EMAIL ADDRESS
EMAIL DESCRIPTION
DESCRIPTION
| *=Required Field |
| Presolicitation Notice |
Presolicitation Notice
The Department of Veterans Affairs (VA), Office of Procurement, Acquisition and Logistics, Strategic Acquisition Center (SAC), intends to award a sole‑source, firm‑fixed‑price requirements contract to Medtronic USA, Inc., 200 Medtronic Drive, Lafayette, CO 80026, for the procurement of the Medtronic Nitron CryoConsole Cardiac Cryoablation System, associated cryoballoon and focal catheters, installation, clinical and technical training, and OEM preventive maintenance and repair services. This action will support enterprise‑wide electrophysiology (EP) laboratory cardiac cryoablation capabilities across participating VA medical centers.
The VA requires an FDA‑cleared, electrophysiology lab integrated cardiac cryoablation platform capable of performing both pulmonary vein isolation using cryoballoon catheters and focal cryoablation using OEM validated catheters on a single console.
The system must include a cart‑based, closed‑loop nitrous‑oxide cryogen delivery console with real‑time pressure and temperature monitoring, automated safety interlocks, EP lab workflow integration, and compatibility with both cryoballoon and focal catheters from the same OEM. The platform must support facility installation, device qualification, staff training, and enterprise level OEM lifecycle service coverage to ensure safe, consistent operation across VA EP laboratories.
Medtronic’s Nitron CryoConsole, Arctic Front cryoballoon catheters, and Freezor focal catheters constitute the only FDA‑approved, OEM‑validated EP lab cryoablation ecosystem capable of meeting these requirements.
Based on market research, including review of FDA‑cleared EP cryoablation technologies, available commercial systems, technical specifications, and current manufacturer product status, no other vendor produces an electrophysiology lab cryoballoon platform with a compatible focal catheter suite validated for use on a single console. No third‑party consoles or catheters are FDA‑validated for use with Medtronic’s system, and use of non‑OEM components would fall outside FDA‑reviewed configurations.
Accordingly, only Medtronic USA, Inc. can meet the VA’s minimum clinical, enterprise‑standardization, and lifecycle sustainment requirements for an EP‑lab‑integrated cardiac cryoablation system.
The applicable North American Industry Classification System (NAICS) code 339112 – Surgical and Medical Instrument Manufacturing is most appropriate for this requirement. The size standard is 1,000 employees. The Product Service Code (PSC) is 6515 – Medical and Surgical Instruments, Equipment, and Supplies.
This notice of intent is not a request for competitive proposals. Interested parties may submit capability statements demonstrating that they can meet all of the Government’s minimum requirements. Capability statements must include sufficient technical detail for consideration. The Government will review all responses received; however, a determination by the Government not to compete the proposed procurement based on any responses is solely within the Government’s discretion. No solicitation is available at this time, and telephone inquiries will not be accepted.
Points of contact are:
Anthony Zibolski, Contracting Officer – anthony.zibolski@va.gov Michael Andrews, Contract Specialist – michael.andrews@va.gov
| *=Required Field |
| Presolicitation Notice |
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Presolicitation Notice
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