Private medical technology company, Bluegrass Vascular Technologies emphasizing on developing innovating lifesaving devices and methods for vascular access asserted the enrollment of its first patients in the SAVE-US pivotal trial. SAVE-US stands for (Surfacer System to Facilitate Access in VEnous Occlusions – United States). It is primarily a pre-market investigational device exempt study in order to examine the safety and efficacy of the Surfacer Inside-Out Access Catheter System enhancing trustworthy upper body central venous access suitable for patients afflicted with upper body venous occlusions or other conditions that prohibit conventional methods of accessing central venous.
Dr. Razavi, Interventional Radiologists responsible for Initial patient enrollments claimed “The Surfacer System has the potential to change the standard of care by offering a new strategy that allows reliable and repeated access to the right internal jugular vein, the optimal location for catheter placement.”
Bluegrass Vascular secured CE Mark approval of the Surfacer System in 2016 and is currently enrolling patients in its post-market SAVE Registry in Europe.
Gabriele Niederauer, Ph.D., CEO and President of Bluegrass Vascular, commented, “It is exciting to be on the forefront of hemodialysis care and provide life-saving solutions that improve patient outcomes while reducing costs. We look forward to treating patients in the SAVE-US pivotal trial and supporting our ongoing commercialization efforts in Europe.”