Vital Access, a manufacturer of surgical and interventional technologies, has secured the US Food and Drug Administration (FDA) market approval for its VWING device, a vascular needle guide developed to enable vascular access to arteriovenous fistulas (AVF) for patients undergoing hemodialysis.
The VWING vascular needle guide is desgined to assist in cannulation of difficult or impossible to access fistulae using the buttonhole cannulation technique. It is completely subcutaneous and extravascular.
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.
Vital Access president and CEO Doug Smith noted the company believes VWING will be the tool of choice for vascular surgeons to overcome anatomical limitations and provide consistent access for dialysis patients.
"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," Smith added.