Bluegrass Vascular Announces Publication of Surfacer System SAVE Registry Results

October 9, 2020

 

San Antonio, TX – Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today the publication of the results from the company’s prospective, multicenter SAVE (Surfacer® System to Facilitate Access in VEnous Occlusions) Registry in the Journal of Vascular and Interventional Radiology (JVIR). The objective of the SAVE Registry was to report Surfacer Inside-Out® Access Catheter System device performance and safety information for patients with thoracic central venous obstruction (TCVO) requiring central venous access. Central venous catheters were successfully placed in 29 of 30 patients (96.7%) with no device-related adverse events or intra- or postprocedural complications reported.

“The SAVE Registry achieved its desired objective of confirming the safety and effectiveness of the Surfacer System to gain central venous access in patients with central venous occlusions,” commented Vladimir Matoussevitch, MD, Executive Senior Physician of the Department of Vascular and Endovascular Surgery, Head of Vascular Access Unit University of Cologne and co-lead author for the paper.

“The publication of the results of the SAVE Registry expands and strengthens the clinical evidence confirming the role the Surfacer System has in helping to establish central venous access in patients with venous obstructions,” stated Maurizio Gallieni, MD, Director of Nephrology and Dialysis at the University of Milan who was the other co-lead author.

 

“We are pleased to have the positive findings from the SAVE Registry published in a prestigious journal like JVIR,” stated Gabriele Niederauer, Ph.D., CEO and President of Bluegrass Vascular. “We are also grateful to the physicians who played a key role in the successful completion of this registry study and the patients who agreed to participate.”

About the Surfacer® Inside-Out® Access Catheter System

The Surfacer System is designed to reliably, efficiently and repeatedly gain central venous access by inserting the Surfacer System through the right femoral vein and navigating it up through the patient’s venous system with an exit point in the right internal jugular vein, the optimal location for placing a central venous catheter. This proprietary Inside-Out approach allows for the placement and maturation of permanent arteriovenous access options that are associated with improved patient outcomes and reduced cost of care for both hospitals and hemodialysis providers. The Surfacer System has received FDA De Novo device clearance in the US and is CE marked in Europe.  The device is currently distributed in North America and Europe by  Merit Medical, a global manufacturer and distributor of medical devices.

About Bluegrass Vascular Technologies

Bluegrass Vascular Technologies is a medical technology company dedicated to developing and commercializing lifesaving devices and methods that address shortcomings in vascular access procedures. For more information, please visit www.bluegrassvascular.com.