Abstract
Vital Access Corporation has 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 most common treatment method for patients with advanced kidney failure.
Background
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.
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. Sadly this doesn’t yet extend to its website which appears to be unfinished at the time of writing.
Company comments
“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.”
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 Fistula E ). For more trial information on the Vital Access IDE trial, please refer to www.clinicaltrials.gov.
Source: Vital Access, PR Newswire
published: February 13, 2012 in: Approval/Clearance, Launches / Withdrawals, Regulatory, Vascular