Vital Access Corp. Announces Publication Of VWING Pivotal Trial Results

SALT LAKE CITY, June 9, 2014 /PRNewswire/ -- Vital Access Corp. today announced that the Journal Of Vascular Surgery has published the results of a 54 subject, six-month follow-up of the VWING™ Vascular Needle Guide that demonstrated the device's safety and efficacy (http://www.jvascsurg.org/article/S0741-5214(14)00764-2/fulltext). 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.

William 'Tip' Jennings, MD, principal investigator in the pivotal SAVE (Salvage of AV Fistulae) study and primary author of the publication, commented, "I expect the VWING 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."

The published SAVE study results demonstrate that the VWING is safe and effective for facilitating vascular access of arteriovenous fistulas (AVF) in patients undergoing hemodialysis. The SAVE study was a multi-center, AVF salvage trial that included 54 dialysis patients with uncannulatable, deep AV fistulas, who were implanted with VWINGs (82 devices were implanted in total) and followed for six months post-implantation.  Eleven trial sites implanted VWING devices and 43 dialysis units participated in VWING patient cannulations throughout the study.

Some key findings of the SAVE study are¹:

• The primary endpoint, effective cannulation within three months, was achieved in 49 of 51 patients evaluated (96%)
• Cumulative AVF patency and survival at six months was 100%
• VWING sites had a maturation rate of 96% and a mean maturation time of 40 days, results that should lead to fewer catheter days
• Rates of device-related serious adverse events were low (0.31 per patient year)
• Rates of sepsis and of site infection were low (0.04 per patient-year and 0.08 per device-year respectively)

Kidney failure affects millions of people worldwide, and hemodialysis via an 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.  In an environment with these and other challenges, the VWING's demonstrated ability to enable use of otherwise uncannulatable fistulas has potential value for both patients and caregivers.

"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, Canada, and New Zealand. For more information please call 801-433-9390 or visit www.vital-access.com. 

References:
^1. Jennings, W., Galt, S., Shenoy, S., Wang, S., Ladenheim, E., Glickman, M., & ... Brown, B. (2014). The Venous Window Needle Guide, a hemodialysis cannulation device for salvage of uncannulatable arteriovenous fistulas. Journal Of Vascular Surgery.

Contact: Doug Smith, 801-433-9390 

SOURCE Vital Access Corporation

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