Vital Access obtains FDA clearance for vascular needle guide

16 September 2013 (Last Updated September 16th, 2013 18:30)

US-based Vital Access has obtained the US Food and Drug Administration (FDA) market clearance for its patented VWING vascular needle guide to provide vascular access for haemodialysis treatment.

US-based Vital Access has obtained the US Food and Drug Administration (FDA) market clearance for its patented VWING vascular needle guide to provide vascular access for haemodialysis treatment.

The vascular needle guide is a subcutaneously implantable extravascular medical device that is surgically attached to the top of an arteriovenous (AV) fistula to provide a palpable target for needle insertion.

VWING's opening at the AV fistula surface allows the needle to directly access the vessel utilising the buttonhole technique which has been demonstrated to minimise vessel damage.

However, due to practical challenges with clinical implementation, the technique has not gained broad adoption.

"It will give nephrologists and dialysis centres the ability to prescribe the most optimal cannulation method for each patient, regardless of clinic staffing or patients' anatomical limitations."

The positive results collected from a recently completed SAVE study demonstrated the VWING vascular needle guide to be an effective and safe tool for uncannulatable AVFs, with a particularly high salvage rate of 96%.

The SAVE study is a multi-centre, AV fistula salvage trial that included 54 dialysis patients with uncannulatable, deep AV fistulae, who were implanted with VWINGs and followed for six months post-implantation.

The study also found high buttonhole cannulation success and low occurrence of device-related adverse effects, including infection and stenosis.

Vital Access president and CEO Doug Smith said: "It will give nephrologists and dialysis centres the ability to prescribe the most optimal cannulation method for each patient, regardless of clinic staffing or patients' anatomical limitations."

VWING is expected to be an alternative option available to vascular surgeons for addressing the access needs of haemodialysis patients by facilitating effective AVF cannulation in a wide range of dialysis patients and achieving better patient outcomes.

The VWING vascular needle guide is also approved and available for use in Europe and Canada.