Bluegrass Vascular Technologies, Inc.
International Save Registry Services
The international SAVE ( Surfacer® System to Facilitate Access in VEnous Occlusions) Registry demonstrated clinical performance and safety of the Surfacer Inside-Out® Access Catheter System used to facilitate the entry and placement of central venous access catheters in patients with limited or diminishing upper body venous access.
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- Prospective, multicenter, post market CE Mark, international clinical study
- N=30 patients referred for placement of a central venous catheter (CVC) and who met the inclusion and exclusion criteria
- All primary safety and performance endpoints were met
- CVCs were placed according to labeled indications in 29 of 30 patients with a 100% success in achieving patency and access
- Absence of adverse events in data reported for all treated patients with a single conversion in one patient (3%) with a significant vascular anomaly preventing access.
- Patients presented with a variety of occlusion types, including:
- 16 patients (30.2%) with bilateral internal jugular (BIJ) and subclavian (SC) occlusion
- 17 patients (32.1%) with brachiocephalic (BC) occlusion
- 12 patients with (22.6%) superior vena cava (SVC) occlusion above the azygos
- 8 patients (15.1%) with total occlusion of the SVC.