6515--Notice of Intent to Sole Source NX EQ Cryotherapy Systems: Tissue Ablation – Cardiac
Key Dates
Due Date
-
Posted Date
-
Agency & Value
Agency
SAC FREDERICK (36C10X)
Contract Value
Not provided
Codes & Classification
Solicitation Number
36C10X26R0028
NAICS
339112 - Surgical and Medical Instrument Manufacturing
Classification Code
6515
Additional Details
Documents1
The Department of Veterans Affairs (VA), through its Office of Procurement, Acquisition and Logistics, Strategic Acquisition Center (SAC), has issued a presolicitation notice indicating its intent to award a sole source, firm fixed price requirements contract to Medtronic USA, Inc. This procurement is focused on acquiring the Medtronic Nitron CryoConsole Cardiac Cryoablation System, along with associated cryoballoon and focal catheters, installation services, clinical and technical training, and original equipment manufacturer (OEM) preventive maintenance and repair services. The overarching goal of this acquisition is to support and standardize enterprise-wide electrophysiology (EP) laboratory cardiac cryoablation capabilities across participating VA medical centers.
The scope of this procurement encompasses the delivery and integration of an FDA-cleared, EP lab-integrated cardiac cryoablation platform. The required system must be capable of performing both pulmonary vein isolation using cryoballoon catheters and focal cryoablation procedures with OEM-validated catheters, all operable from a single console. Key system features include a cart-based, closed-loop nitrous oxide cryogen delivery console equipped with real-time pressure and temperature monitoring, automated safety interlocks, seamless EP lab workflow integration, and compatibility with both cryoballoon and focal catheters from the same OEM. The contract also mandates comprehensive facility installation, device qualification, staff training, and enterprise-level OEM lifecycle service coverage to ensure safe and consistent operation across all VA EP laboratories.
The intended outcome of this procurement is to ensure that VA medical centers are equipped with a standardized, reliable, and clinically validated cardiac cryoablation ecosystem. Medtronic’s Nitron CryoConsole, Arctic Front cryoballoon catheters, and Freezor focal catheters are identified as the only FDA-approved, OEM-validated EP lab cryoablation solution capable of meeting the VA’s stringent requirements for clinical performance, enterprise standardization, and lifecycle sustainment. Market research conducted by the VA, including a review of FDA-cleared technologies and available commercial systems, has determined that no other vendor offers an electrophysiology lab cryoballoon platform with a compatible focal catheter suite validated for use on a single console. Furthermore, the use of non-OEM components would not comply with FDA-reviewed configurations, reinforcing the necessity for a sole source award to Medtronic USA, Inc.
This procurement is classified under NAICS code 339112 (Surgical and Medical Instrument Manufacturing), with a size standard of 1,000 employees, and Product Service Code (PSC) 6515 (Medical and Surgical Instruments, Equipment, and Supplies). The contracting entity is the SAC Frederick office (36C10X), a federal office within the Department of Veterans Affairs.
While this notice is not a request for competitive proposals, interested parties are invited to submit capability statements that demonstrate their ability to meet all of the Government’s minimum requirements. Such statements must provide sufficient technical detail for consideration. The Government will review all responses received, but reserves the right to proceed with the sole source procurement at its discretion. No formal solicitation is available at this time, and telephone inquiries will not be accepted.
For further information or to submit capability statements, interested parties may contact Anthony Zibolski, Contracting Officer ([email protected]), or Michael Andrews, Contract Specialist ([email protected]).
This opportunity remains active, with a response deadline of May 8, 2026. Additional details and updates can be found at the official SAM.gov listing: https://sam.gov/opp/a29e810deec3495dbad1d9c24ef6381e/view.