This Pre-Solicitation opportunity from Department Of Veterans Affairs was posted on April 23, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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6515--Notice of Intent to Sole Source NX EQ Cryotherapy Systems: Tissue Ablation â€“ Cardiac

Closed

36C10X26R0028Federal

Submission Closed05/08/2026, 02:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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MEDICAL SUPPLY CHAIN MD SURG FSF

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1 day ago

DEADLINE

in 4 days

AI Contract Overview

The Department of Veterans Affairs, through its Strategic Acquisition Center in Frederick, Maryland, intends to award a sole-source, firm-fixed-price requirements contract to Medtronic USA, Inc. for the procurement of its Nitron CryoConsole Cardiac Cryoablation System and associated components. This acquisition is designed to establish enterprise-wide cardiac cryoablation capabilities across participating VA medical centers, enabling both pulmonary vein isolation using cryoballoon catheters and focal cryoablation using validated focal catheters on a single, integrated platform. The system must be an FDA-cleared, cart-based, closed-loop nitrous oxide cryogen delivery console with real-time pressure and temperature monitoring, automated safety interlocks, and seamless integration into electrophysiology lab workflows. Only Medtronic’s complete ecosystem—including the Arctic Front cryoballoon and Freezor focal catheters—is currently FDA-validated for this combined use, and no other vendor offers a technically equivalent system that meets the required clinical, operational, and lifecycle sustainment standards. Non-OEM components are excluded because they fall outside of FDA-reviewed configurations, making Medtronic the only viable provider. The contract will encompass delivery of the console and catheters, on-site installation and device qualification, comprehensive clinical and technical training for VA staff, and enterprise-level preventive maintenance and repair services throughout the life of the system. All performance will occur across VA medical centers nationwide, with no single delivery location specified. The procurement is justified under NAICS code 339112 for Surgical and Medical Instrument Manufacturing, with a size standard of 1,000 employees, and classified under Product Service Code 6515. No competitive solicitation is being issued; instead, interested parties may submit capability statements demonstrating their ability to meet the full set of technical and regulatory requirements by May 8, 2026. The government retains full discretion to determine whether any responses justify opening competition, but based on current market research, no alternative vendor exists that can satisfy the mandatory clinical and regulatory criteria. Contract administration responsibilities are assigned to Contracting Officer Anthony Zibolski and Contract Specialist Michael Andrews, with no COR or COTR named. The procurement does not include pricing data, delivery schedules, FOB terms, packaging specifications, or formal evaluation factors, as this document is strictly a presolicitation notice to gather market feedback prior to finalizing the sole-source award.

General Info

VA awards sole source fixed-price contract to Medtronic for cardiac cryoablation system and services.

Agency

Department Of Veterans Affairs → Sac Frederick (36C10X)View Agency

NAICS

339112 - Surgical and Medical Instrument ManufacturingView NAICS

Place of Performance

Nationwide, MD

Set-Aside

NONE

Documents

(1)

36C10X26R0028.docx

DOCX

AI Contract Breakdown

Uniform Contract Format

Timeline

PhaseClosed

PostedApr 23

Presolicitation

Response DeadlineMay 8

Deadline has passed

Submission Closed

05/08/2026, 02:00:00 PM UTC

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Organization & Contact Information

AgencyDepartment Of Veterans Affairs → Sac Frederick (36C10X)

Contacts1 person available

OfficeFREDERICK, MD, 21703, USA

Organization / Agency

Department Of Veterans Affairs → Sac Frederick (36C10X)

View Agency Profile

Office AddressFREDERICK, MD, 21703, USA

Contacts

Anthony ZibolskiContracting Officer

contact@example.gov

Full Description

Presolicitation Notice
Presolicitation Notice
Page 6 of 6 Presolicitation Notice *=Required Field Presolicitation Notice
Page 1 of 6 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