Clinical Studies Services

FromBluegrass Vascular Technologies, Inc.

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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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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

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)