Surfacer® Inside-Out® Access Catheter System

To restore and preserve access in chronically occluded veins, John Gurley, M.D.² developed the Inside-Out^® approach – allowing clinicians to change the standard of care.

RESTORE ACCESS AND SUSTAIN CENTRAL VENOUS ACCESS

• Achieves reliable and repeatable central venous access to the right internal jugular (RIJ) vein
• Preserves the viability of secondary central veins
• Optimizes placement and maturation of permanent AV access

RELIABLE PROCEDURE

• 100% (12 of 12) of patients underwent successful central venous access placement³
• 100% (12 of 12) of patients maintained patency of central venous access through long-term follow-up visit³
• No device-related adverse events were reported within 48 hours and at 14-day follow-up visit¹

REDUCE COSTS

• Supports the achievement of permanent AV access which reduces hemodialysis provider cost and downtime by decreasing catheter-associated morbidity and complications¹
• Easier, minimally invasive procedure compared to surgical bypass for patients with totally occluded central veins

Inside-Out® Approach

To restore and preserve access in chronically occluded veins, John Gurley, M.D. developed the Inside-Out^® approach – allowing clinicians to change the standard of care.

The Surfacer^® System is inserted through the femoral vein and navigated to an exit point in the right internal jugular (RIJ) vein. This proprietary Inside-Out^® approach achieves access to an occluded RIJ vein while preserving the viability of secondary central veins.

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.

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
• SAFETY

TO LEARN MORE, CONTACT BLUEGRASS VASCULAR TECHNOLOGIES, INC.

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.

E.U. Post-market Clinical Experience with Surfacer System White Paper

REFERENCES

1. Data on file
2. Department of Cardiology, University of Kentucky, Lexington, KY, USA.
3. Ebner A, Gallo S, Cetraro C, Gurley J, Minarsch L. Inside-Out Upper Body Venous Access: The first-in-human experiences with a novel approach using the Surfacer Inside-out Access Catheter System. Endovascular Today. June 2013.

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 unrelated to the Surfacer device. Manual compression was not required.
b. At 48-hour and 14-day follow-up.