Clinical Studies

SAVE-US PIVOTAL TRIAL (STATUS: Study Completed)

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.

View peer-reviewed publication in the Journal of Vascular Access

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)

INTERNATIONAL SAVE REGISTRY (STATUS: Study Completed)

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.

View peer-reviewed publication in JVIR

Design and Methodology

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

Clinical Results

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.

FIRST-IN HUMAN STUDY (STATUS: Completed)

The first-in-human study was designed to assess the safety and feasibility of the Surfacer® Inside-Out® Access Catheter System.

to learn more, view the article published in endovascular today

Design and Methodology

Single-center feasibility study
N=12 patients with compromised upper venous occlusive disease

Results

All 12 patients received an access catheter, which remained in place and functional throughout long-term follow-up of 14 days. Results demonstrate this novel Inside-Out approach provides safe and effective percutaneous central venous access, despite chronic occlusion of the superior vena cava.

1126_BV_Website_ClinicalStudy_Chart

_{a. Mild hematoma at the clavicular exit due to tunneling and unrelated to the Surfacer device. Manual compression was not required.

b. At 48-hour and 14-day follow-up.}