CE Mark Clearance for Vital Access’s Implantable Hemodialysis Access Device
SALT LAKE CITY, Feb. 8, 2012 /PRNewswire/ — Vital Access Corporation today announced that its Venous Window(TM) Needle Guide has been granted CE Mark clearance for use in Europe to provide vascular access for hemodialysis treatment, the most common treatment method for patients with advanced kidney failure.
As a result of CE Mark clearance, Vital Access(TM) 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.”
The Venous Window Needle Guide is a subcutaneously implantable medical device that is surgically attached to the top of an Arteriovenous (AV) 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 which has been demonstrated to minimize vessel damage.
Vital Access was granted CE Mark clearance for its Venous Window Needle Guide following successful implantation and repeated cannulation during its First in Human clinical trial conducted at sites in New Zealand. Leading the clinical trial as Principal Investigator was Dr. Andrew Hill, MBChB, FRACS.
United States Clinical Trial
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). For more trial information on the Vital Access IDE trial, please refer to www.clinicaltrials.gov.
About Vital Access
Vital Access Corporation, founded by Dr. Duane Blatter MD, is a privately held medical device company located in Salt Lake City, Utah that specializes in technologies to improve vascular access. For more information, please call 801-433-9390.
© 2012 Vital Access Corporation. All Rights Reserved. Vital Access and Venous Window are trademarks of Vital Access Corporation.
Vital Access Contact
Doug Smith, 801-433-9390
SOURCE Vital Access Corporation