Bluegrass Vascular Technologies has received CE mark approval for its Surfacer Inside-Out access catheter system.
Via novel Inside-Out approach, the Surfacer system will facilitate catheter insertion into the central venous system.
Designed for central venous access, the system will be inserted through the femoral vein and navigated it up by the patient’s venous system with an exit point in the right internal jugular vein, the optimal location for placing a central venous catheter.
The Inside-Out approach enables to place and mature permanent arteriovenous access options, helping to improve patient outcomes and reduce costs for both hospitals and hemodialysis providers.
The Surfacer system has been introduced in limited markets such as the UK, Germany, Austria, Italy, and the Benelux.
In addition, the firm will begin the recruitment of patients in the Surfacer system’s access in venous occlusions (SAVE) study.
The study is an observational and post-market registry for patients with limited or diminishing upper body venous access or pathology impeding standard access methods.
Bluegrass Vascular CEO and president Gabriele Niederauer said: “This is a major milestone both for our company and for patients with occlusive disease.
“After successful use of our device in initial commercial cases and previously under Germany’s Compassionate Use Program, we are eager to commercialize the system in Europe and meet the clinical demand from physicians treating patients with occluded central veins.”