Bluegrass Vascular Technologies, Inc. (BVT), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, 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, which grants access to physicians for use of medical devices not yet CE Mark approved in Europe, particularly in Germany, for patients who are diagnosed with advanced diseases and fail to respond to existing treatment options.
The procedure was performed by Dr. Eckehard Mündlein, Director of the Dialysis and Vascular Access Center at Ortenau Hospital in Offenburg, Germany.
“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,” stated Dr. Mündlein. “The Surfacer System enabled us to restore repeatable access to the patient’s right internal jugular (RIJ) 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.”
“We are glad we were able to provide Dr. Mündlein and his team access to the Surfacer System for his patient,” stated Gabriele Niederauer, PhD, CEO and President of Bluegrass Vascular Technologies. “Central venous obstruction is a very serious problem for patients undergoing hemodialysis therapy and often results in the use of alternative veins, other than the RIJ vein. This often impedes the subsequent placement and maturation of permanent arteriovenous access options, which decrease patient morbidity and the cost of care. The Surfacer System ensures that valuable venous real estate will not be depleted, thus avoiding damage to other veins, and in patients with totally occluded veins, providing an alternative to extremely invasive and costly surgery for catheter placement.”
The Surfacer System is designed to permit physicians the ability to reliably gain central venous access from the inside out by inserting the Surfacer System through the femoral vein and navigating it up through the patient’s venous system with an exit point in the RIJ vein, the optimal location for placing a central venous catheter. The proprietary 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.
Bluegrass Vascular Technologies has applied for CE Mark certification and plans to commercialize the Surfacer System in Europe in the upcoming months. In addition, BVT recently received International Organization for Standardization (ISO) 13485:2003 certification, an internationally recognized quality standard for medical devices, demonstrating the company’s commitment to the highest level of quality management and design controls to ensure delivery of safe and effective products.