SAM #36C24827Q0117

VA intended sole-source procurement of Cagent Vascular Serranator PTA serration balloon catheters

The Department of Veterans Affairs (VA), VISN 8, Network Contracting Office 8, Prosthetics Department in Tampa, intends to award a sole-source procurement to Cagent Vascular Inc. for Serranator® PTA Serration Balloon Catheters. - Procurement approach: The notice describes an intended sole-source award to Cagent Vascular Inc.; it is not a request for competitive quotes. - Product: Serranator peripheral angioplasty catheters use serrated elements on a semi-compliant balloon to modify lesions during inflation. The stated uses include peripheral artery disease and certain obstructive dialysis fistula lesions. - Listed configurations: An attachment identifies seven configurations, with balloon diameters from 2.0 to 4.0 mm and lengths of 40 or 120 mm. Part numbers and guidewire and sheath compatibility are listed below; quantities are not provided. - Key requirements: Catheters must be sterile, disposable, single-use, over-the-wire, 150 cm working length, and include radiopaque markers. Manufacturer instructions and balloon compliance, nominal inflation pressure, and rated burst pressure information are required. - Response context: Interested parties may provide information for the government to consider in assessing whether competition is appropriate.

Description

DESCRIPTION: Department Of Veterans Affairs, VISN8, Network Contracting Office 8, Prosthetics Department, Tampa, FL, hereby Gives Notice of Intent to Award a Sole Source to Cagent Vascular Inc, 50 Strafford Avenue Suite 315, Wayne, Pa 19087.

DELIVERABLES: The Serranator® PTA Serration Balloon Catheter is a peripheral angioplasty device from Cagent Vascular designed for the treatment of peripheral artery disease (PAD) and certain arteriovenous (AV) fistula lesions. Unlike a standard PTA balloon, it incorporates serrated scoring elements on the balloon surface that create controlled micro-incisions (micro-fissures) in the vessel wall during inflation. This approach is intended to improve lumen expansion while reducing recoil and uncontrolled dissections. [cagentvascular.com], [cagentvascular.com] KEY FEATURES Serration Remodeling Therapy (SRT) technology. Semi-compliant balloon with embedded serrated metal elements. Designed to generate focused point force rather than uniform circumferential stretching. Available in multiple balloon diameters and lengths for peripheral interventions. [cagentvascular.com], [fda.innolitics.com] THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTES. The North American Industry Classification System (NAICS) number is 339113. A decision by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct competitive procurement. Parties may identify their interest, accompanied by supporting literature to the Contracting Officer no later than 11/11/2026 at 12:00 PM EST. Responses should be sent to shirley.courtney@va.gov. Responses received will be evaluated; however, a determination by the Government not to compete the proposed procurement will be solely up to the government.

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