Introducing the Surfacer® Inside-Out® Access Catheter System, the proprietary Inside-Out® approach to restore access and preserve options™.
In patients with chronically occluded central veins, the current approach is to move to another vein if a subsequent central venous catheter (CVC) is needed. Failed venous access attempts may prevent permanent arteriovenous (AV) access, increasing patient morbidity and the overall cost of care.1
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
- 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
- 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
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.
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
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.
Design and methodology
- Single-center feasibility study
- N=12 patients with compromised upper venous occlusive disease
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.
- Data on file
- Department of Cardiology, University of Kentucky, Lexington, KY, USA.
- 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.
Inside-Out Upper Body Venous Access: The first-in-human experiences with a novel approach using the Surfacer Inside-out Access Catheter System
Ebner A, Gallo S, Cetraro C, Gurley J, Minarsch L
Endovascular Today, June 2013.
Inside-Out® Upper Body Venous Access: First-in-Human Experience with a Novel Approach using the Surfacer® Inside-Out® Access Catheter System
Dr. Adrian Ebner, Dr. Santiago Gallo, Carlos Cetraro, RT, Dr. John Gurley, Laura Minarsch, RT (R), CVT, RCIS
A 30-year-old woman with renal failure required central venous access for hemodialysis. Angiography demonstrated chronic total occlusion of the internal jugular and subclavian veins, as well as total occlusion of the superior vena cava at the level of the right atrium. Attempts to obtain access by conventional methods failed, and the patient was referred for inside-out access using the Surfacer® Inside-Out® Access Catheter System.
TO REQUEST THE CASE STUDY, CONTACT BLUEGRASS VASCULAR TECHNOLOGIES, INC.
Novel “Inside Out” Approach to Central Venous Access in Patients with Occlusive Disease Requiring Hemodialysis
Gurley J, Minarsch L, Gallo S, Alvarez E, Silva E, Cetraro C, Ebner A
Presented at ISET 2013.
Insideout Central Venous Access – Presentation (University of Kentucky May 9, 2012)
Heart Rhythm Society 2012, May 912, Boston MA.
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