Bluegrass Vascular Technologies has begun the US pivotal trial to assess the safety and efficacy of the Surfacer inside-out access catheter system.
The company has recruited first patients in the SAVE-US (Surfacer system to facilitate access in venous occlusions – United States) pivotal study.
The study will assess the safety and efficacy of the Surfacer system to facilitate dependable upper body central venous access suitable for patients with upper body venous occlusions or other conditions that prevent central venous access by conventional methods.
Surfacer system has been developed for effective 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 advanced inside-out approach enables the placement and maturation of permanent arteriovenous access options.
Bluegrass will recruit up to 30 patients in 10 centers in the US, as well as additional centers in Europe.
California-based St. Joseph Hospital interventional radiologists Dr Chris Loh and Dr Mahmood Razavi have recruited early patients in the trial. Houston Methodist Hospital vascular surgeon Dr Eric Peden has also involved in the recruitment of patients.
Razavi said: "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.”
In 2016, the company secured CE mark approval for the Surfacer system, and is currently recruiting patients in its post-market SAVE registry in Europe.
Merit Medical distributes the Surfacer system to the customers in Europe.
Bluegrass Vascular CEO and president Dr Gabriele Niederauer said: "It is exciting to be on the forefront of hemodialysis care and provide life-saving solutions that improve patient outcomes while reducing costs.”
Image: Bluegrass Vascular’s Surfacer inside-out access catheter system. Photo: courtesy of Bluegrass Vascular Technologies.