Serranator Characteristics.docx

This document specifies the minimum required features and specifications for Serranator peripheral vascular intervention catheters that the Department of Veterans Affairs, VISN 8, intends to procure through sole source award to Cagent Vascular Inc. The catheters must feature balloon-mounted serration technology to provide controlled mechanical lesion modification during peripheral angioplasty, with indicated uses for dilation of peripheral arterial lesions and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae. All units must be sterile, disposable, single-use devices with over-the-wire catheter design and 150 cm working length, equipped with radiopaque markers for fluoroscopic positioning and manufacturer documentation detailing balloon compliance, nominal inflation pressure, and rated burst pressure.

The procurement requires seven specific product configurations with balloon diameters ranging from 2.0 mm to 4.0 mm, lengths of either 40 mm or 120 mm, and compatibility with either 0.014-inch or 0.018-inch guidewires and 5 Fr or 6 Fr sheaths as specified. Interested parties must submit responses demonstrating interest and supporting literature to the Contracting Officer, Shirley Courtney (shirley.courtney@va.gov), no later than November 11, 2026 at 12:00 PM EST. The North American Industry Classification System (NAICS) code is 339113, and the Government reserves the right to determine whether to conduct competitive procurement based on responses received.