Salt Lake City - September 16, 2013 - Vital Access Corp. today announced that it has received U.S. Food and Drug Administration (FDA) market clearance for its patented VWING™ Vascular Needle Guide which has been shown to enable vascular access to arteriovenous fistulas (AVF) for patients undergoing hemodialysis.
Kidney failure affects millions of people worldwide, and hemodialysis via an autologous arteriovenous fistula (AVF) is the global gold standard for patients undergoing treatment. However, establishing and maintaining reliable vascular access continues to be a significant challenge, made worse in recent years by the growing prevalence of obesity, diabetes and hypertension amongst kidney failure patients.
The VWING is a surgically placed vascular needle guide that is completely subcutaneous and extravascular. The VWING provides an easily palpable target for needle insertion and guides a dialysis needle directly to the targeted vessel, enabling the use of blunt needles via a guided constant site or “buttonhole” cannulation. Buttonhole cannulation technique has been shown in multiple clinical studies to reduce AV fistulae complications and improve long-term fistula durability and patency. However, the technique has not gained broad adoption due to practical challenges with clinical implementation. The VWING has demonstrated its ability to enable the use of buttonhole cannulation technique.
The VWING is supported by robust clinical evidence collected in the recently completed SAVE study. The study was a multi-center, AV fistula salvage trial that included 54 dialysis patients with uncannulatable, deep AV fistulae, who were implanted with VWINGs (82 devices were implanted in total) and followed for 6 months post-implantation. Duane Blatter, M.D., Founder and Chief Medical Officer of Vital Access Corp. states, “The SAVE study demonstrated that the VWING Vascular Needle Guide is an effective and safe tool for uncannulatable AVFs, with an impressive salvage rate of 96%. The study also demonstrated high buttonhole cannulation success and low occurrence of device related adverse events, including infection and stenosis. I believe the VWING will enable clinicians to better address the access needs of hemodialysis patients by facilitating effective AVF cannulation in a wide range of dialysis patients.”
"The VWING Vascular Needle Guide is an exciting addition to the armamentarium of the vascular access surgeon," said Spencer Galt, MD, a principal investigator in the SAVE Study. "I believe it will render surgical superficialization obsolete. I have placed numerous VWING devices, and I am very happy that it is now available to all access surgeons. It will help support the Fistula First Initiative," he added.
Tip Jennings, vascular surgeon and principal investigator in the SAVE Study, commented, “I expect the device will be an important option for vascular access surgeons. Non-usable fistulas were easily converted to a reliable vascular access quickly, using the VWING implanted in a relatively minor procedure. Both patients and staff were very pleased with the outcomes.”
“We believe VWING will be the tool of choice for vascular surgeons to overcome anatomical limitations and provide consistent access for dialysis patients.” said Vital Access President and CEO, Doug Smith. "Moreover, it will give nephrologists and dialysis centers the ability to prescribe the most optimal cannulation method for each patient, regardless of clinic staffing or patients’ anatomical limitations.”
About Vital Access
Vital Access Corporation is a privately held company located in Salt Lake City, Utah that designs and manufactures surgical and interventional technologies to improve vascular access for patients and their caregivers. The VWING Vascular Needle Guide is also approved and available for use in Europe and Canada. For more information please call 801-433-9390 or visit www.vital-access.com.