Clinical Studies

INTERNATIONAL SAVE REGISTRY (STATUS: Enrollment 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.

 

to learn more, view poster presented at LINC 2019

 

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.

SAVE-US PIVOTAL TRIAL (STATUS: Enrollment 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 Press Release

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)

FIRST-IN HUMAN STUDY (STATUS: Complete)

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.