SAM #36C10X26R0028

VA Sole Source Procurement: Medtronic Cardiac Cryoablation Systems and Services

The Department of Veterans Affairs (VA), Strategic Acquisition Center (SAC) Frederick, is planning a sole source procurement for advanced cardiac cryoablation systems and related services for VA electrophysiology (EP) laboratories nationwide. - Government Buyer: - Department of Veterans Affairs (VA), Office of Procurement, Acquisition and Logistics, Strategic Acquisition Center (SAC) Frederick - Original Equipment Manufacturer (OEM): - Medtronic USA, Inc. (highlighted as the only OEM capable of meeting requirements) - Products Requested: - Medtronic Nitron CryoConsole Cardiac Cryoablation System - Cart-based, closed loop nitrous oxide cryogen delivery console - Real-time pressure and temperature monitoring - Automated safety interlocks - EP lab workflow integration - Compatible with both cryoballoon and focal catheters from Medtronic - Medtronic Arctic Front Cryoballoon Catheter (for pulmonary vein isolation) - Medtronic Freezor Focal Catheter (for focal cryoablation) - Services Requested: - Installation and device qualification - Clinical and technical training for staff - OEM preventive maintenance and repair services (enterprise-level lifecycle coverage) - Unique/Notable Requirements: - System must be FDA-cleared and fully integrated for both pulmonary vein isolation and focal cryoablation on a single console - Only Medtronic offers a platform with validated catheters for use on a single console; no third-party consoles or catheters are FDA validated for this system - Requirement supports enterprise-wide cardiac cryoablation capabilities across participating VA medical centers - Place of Performance: - Nationwide VA medical centers (delivery and installation) - Contracting office: VA Strategic Acquisition Center, 5202 Presidents Court, Suite 103, Frederick, MD 21703

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

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