August 29, 2016
Bluegrass Vascular's Surfacer Inside-Out Access Catheter System Approved in Europe
August 30, 2016—Bluegrass Vascular Technologies announced that it has received European CE Mark approval for its Surfacer Inside-Out access catheter system, which is indicated for obtaining central venous access to facilitate catheter insertion into the central venous system via an “inside-out” approach. The Surfacer system is available in limited markets, including the United Kingdom, Germany, Austria, Italy, and the Benelux countries.
Bluegrass Vascular will also commence enrollment in SAVE, the Surfacer System to Facilitate Access in Venous Occlusions study. SAVE is an observational postmarket registry for patients with limited or diminishing upper body venous access or pathology impeding standard access methods.
The Surfacer system is inserted through the femoral vein and navigated through the patient’s venous system with an exit point in the right internal jugular vein. This technique 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, stated Bluegrass Vascular.
In the company’s press release, Gürkan Sengölge, MD, commented, “The launch of the Surfacer system in Europe brings a much-needed solution to a growing population of patients requiring vascular access for vital treatments and who currently have limited options due to obstructed upper body access. I was very pleased with my first commercial use of the Surfacer system. No other device offers such an innovative inside-out method for restoring access and preserving options in patients with chronically occluded veins. Based on my initial experience, I am confident that the Surfacer system will change the standard of care going forward.” Dr. Sengölge is Associate Professor of Medicine, Nephrology, and Intensive Care Medicine at the Medical University of Vienna in Austria.
John Gurley, MD, who is Bluegrass Vascular’s Founder and Developer of the inside-out method, added, “Multiple central venous occlusions can cause significant long-term morbidity. The novel inside-out approach is an innovative and simple method that restores and preserves right-sided venous access despite chronic occlusion and retains the viability of other existing central veins.” Dr. Gurley is an Interventional Cardiologist at University of Kentucky Medical Center in Lexington, Kentucky.