SAVE-US Pivotal Trial Begins for Bluegrass Vascular's Surfacer Inside-Out Device
January 18, 2018—Bluegrass Vascular Technologies, Inc. announced the enrollment of the first patients in the SAVE-US (Surfacer System to Facilitate Access in Venous Occlusions—United States) pivotal trial.
The SAVE-US clinical trial is an investigational device exemption study evaluating the safety and efficacy of Bluegrass Vascular's 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. The trial will enroll 30 patients at up to 10 centers in the United States along with additional centers in Europe.
The procedures for the first patients enrolled were performed by interventional radiologists Chris Loh, MD, and Mahmood Razavi, MD, at St. Joseph Hospital in Orange, California and by Eric Peden, MD, a vascular surgeon at Houston Methodist Hospital in Houston, Texas.
In the company's announcement, Dr. Razavi commented, “Central venous obstruction is a serious disease that often causes a domino effect of vascular destruction, leaving hemodialysis patients and their physicians with limited options. 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.”
Dr. Peden added, “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. I am excited to participate in the SAVE-US pivotal trial and help bring this clinically beneficial technology to patients in my practice and across the United States.”
According to the company, the Surfacer system is designed to reliably, efficiently, and repeatedly gain central venous access through a femoral vein approach and navigation through the venous system to an exit point in the right internal jugular vein, the optimal location for placing a central venous catheter. The company's "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.
Bluegrass Vascular secured European CE Mark approval of the Surfacer system in 2016. The company is currently enrolling patients in its postmarket SAVE registry in Europe. The Surfacer system is distributed in Europe by Merit Medical Systems, Inc.