Clinical Studies

SAVE STUDY (Status: Enrolling)

The SAVE ( Surfacer® System to Facilitate Access in VEnous Occlusions) Clinical Study is designed to confirm 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.

to learn more, contact us

 

Design and methodology

  • Prospective, multicenter, post market clinical follow-up study
  • Patients referred for placement of a central venous catheter (CVC) and who meet the inclusion and exclusion criteria

Primary endpoints

  • PERFORMANCE
    Implementation success rate: ability to facilitate placement of CVCs using the Surfacer System to establish a transient passage across venous occlusions
  • SAFETY
    Safety evaluation at the end of the procedure and at discharge/1 week, which includes overall serious adverse event/complication rate

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.