Vital Access Corporation today announced that its Venous Window Needle Guide has been granted CE Mark clearance for use in Europe to provide vascular access for hemodialysis treatment. The Venous Window Needle Guide is a subcutaneously implantable medical device that is surgically attached to the top of an Arteriovenous Fistula to provide a palpable target beneath the skin.  When used, the Venous Window Needle Guide acts as a funnel directing a dialysis needle to the patient's AV Fistula.  The Venous Window Needle Guide's opening at the AV Fistula surface allows the needle to directly access the vessel utilizing the Buttonhole Technique.

As a result of CE Mark clearance, Vital Access has begun initial efforts to ramp-up sales and marketing in Europe for its Venous Window Needle Guide. "This is a major milestone that our team has been focused on since the inception of the company.  This approval allows us to begin selling in over 30 countries in Europe and to expand access around the world," stated Doug Smith, President and CEO of Vital Access.  He added, "Most important, we are excited to provide solutions to kidney failure patients to help in their struggle to maintain and improve their dialysis access sites."

Vital Access is currently conducting a pivotal IDE trial in the United States called the SAVE Trial (Vital Access Venous Window Needle Guide for Salvage of AV FistulaE).