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# Bluegrass Vascular ‘De Novo’ for Catheter System
- URL: https://www.fdaweb.com/bluegrass-vascular-de-novo-for-catheter-system/
- Published: 2020-02-14T12:00:00.000Z
- Updated: 2026-09-14T16:03:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146098

FDA has granted Bluegrass Vascular Technologies a de novo marketing order for its Surfacer Inside-Out Access Catheter System. The device is intended to obtain central venous access to allow catheter insertion into the central venous system for patients with upper body venous occlusions or other conditions that preclude access by conventional methods, the company says. FDA based its decision on data from the SAVE-US trial, the company says. It enrolled 30 patients and 90% met both the primary and secondary efficacy endpoints despite a complex patient population having Type 3 and 4 obstructions (3 or more obstructed vessels). No device-related adverse events were reported, it says.