Clinical Studies Services
The SAVE-US (Surfacer® System to Facilitate Access in VEnous Occlusions – United States) pivotal trial demonstrated positive clinical results, confirming clinical performance and safety of the Surfacer Inside-Out® Access Catheter System 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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Design and Methodology
- Prospective, multicenter, pre-market pivotal trial
- N=30 patients referred for placement of a central venous catheter (CVC) and who meet the inclusion and exclusion criteria
Clinical Results
- 90% met both the primary and secondary efficacy endpoints of facilitated central venous access by the Surfacer System
- No device related or unanticipated adverse events with complication rates lower than historical data supporting safety endpoints for standard of care approaches to central venous access
- On average, central venous access was achieved in approximately 19 minutes despite a more complex patient population comprised largely of Type 3 and 4 occlusions (3 or more occluded vessels)
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