Bluegrass Vascular Technologies has announced the enrolment of its first patients in the SAVE-US (Surfacer System to Facilitate Access in Venous Occlusions–United States) pivotal trial.
The SAVE-US trial is a pre-market investigational device exempt (IDE) study evaluating the safety and efficacy of the Surfacer Inside-Out Access Catheter System to facilitate reliable upper body central venous access suitable for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods. Thirty patients will be enrolled at up to 10 centres in the USA with additional centres in Europe.
Initial patient enrolments were performed by interventional radiologists Chris Loh and Mahmood Razavi at St Joseph Hospital in Orange, USA, and by Eric Peden, a vascular surgeon at Houston Methodist Hospital in Houston, USA.
“Central venous obstruction is a serious disease that often causes a domino effect of vascular destruction, leaving haemodialysis patients and their physicians with limited options,” says Razavi. “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.”
“Use of the Surfacer System helps preserve and restore venous territory for vascular access, supporting fistula and graft placement, and reduces catheter-related infections and costs,” states Peden. “I am excited to participate in the SAVE-US trial and help bring this clinically beneficial technology to patients in my practice and across the USA.”
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. The Surfacer System is distributed in Europe by Merit Medical.
Gabriele Niederauer, CEO and president of Bluegrass Vascular, comments, “It is exciting to be on the forefront of haemodialysis care and provide life-saving solutions that improve patient outcomes while reducing costs. We look forward to treating patients in the SAVE-US trial and supporting our ongoing commercialisation efforts in Europe.”