6515--Serranator PTA Serration Balloon Catheters
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The Department of Veterans Affairs, VISN8, Network Contracting Office 8 in Tampa, Florida, has issued a Notice of Intent to award a sole source contract to Cagent Vascular Inc for Serranator PTA Serration Balloon Catheters. These specialized peripheral angioplasty devices are designed to treat peripheral artery disease and arteriovenous fistula lesions using Serration Remodeling Therapy technology. This technology utilizes serrated scoring elements to create controlled micro-incisions in the vessel wall, which improves lumen expansion and reduces recoil compared to standard balloons. The procurement falls under NAICS code 339113. The required catheters must be sterile, disposable, single-use devices featuring an over-the-wire design with a 150 cm working length and radiopaque markers for fluoroscopy positioning. Each unit must be accompanied by manufacturer instructions, balloon compliance information, nominal inflation pressure, and rated burst pressure. While this is a notice of intent and not a request for competitive quotes, interested parties may submit supporting literature to Contracting Officer Shirley Courtney by November 11, 2026, at 12:00 PM EST for the government to determine if the procurement should be competed.
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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 contact@example.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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