March 28, 2016
First Use of Bluegrass Surfacer Inside-Out Access Catheter System Performed in Europe
March 29, 2016—Bluegrass Vascular Technologies, Inc. announced today that its Surfacer Inside-Out access catheter system was successfully used on a patient facing life-threatening complications from end-stage renal disease. The procedure was performed under Germany's compassionate use program. Bluegrass Vascular Technologies has applied for European CE Mark approval and plans to commercialize the Surfacer system in Europe in the upcoming months.
The procedure was performed by Eckehard Mündlein, MD, Director of the Dialysis and Vascular Access Center at Ortenau Hospital in Offenburg, Germany.
In the company’s press release, Dr. Mündlein commented, “Earlier this month we successfully performed a hemodialysis catheter replacement procedure utilizing the Surfacer system, which allowed a patient with complete obstruction of all four central veins facing life-threatening complications from end-stage renal disease to continue to receive life-sustaining dialysis therapy. The Surfacer system enabled us to restore repeatable access to the patient's right internal jugular vein, which had been obstructed by numerous surgical interventions. The ability to insert a catheter in this preferential anatomical location will allow this patient to continue dialysis therapy while also preserving the remainder of the patient's vasculature.”
According to the company, the Surfacer system is designed to permit physicians the ability to reliably gain central venous access from the inside out by inserting the device through the femoral vein and navigating it up through 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 BlueGrass Inside-Out approach restores and preserves venous access while retaining the viability of existing central veins. This allows the placement and maturation of permanent arteriovenous access options that are associated with improved patient outcomes and reduced cost of care, stated the company.