Vital Access launches SAVE-2 post-market clinical follow-up study

Vital Access Corporation today announced the launch of the SAVE-2 post-market clinical follow-up study. The SAVE-2  study follows the U.S. SAVE study, an IDE pivotal trial that clearly demonstrated the benefits of the VWING™ Vascular Needle Guide in restoring vascular access to hemodialysis patients with uncannulatable and deep arteriovenous fistulae. This robust clinical evidence supported the recent U.S. market clearance of the VWING.

SAVE-2 will enroll up to 60 patients covering a broad landscape of hemodialysis access needs. Two patient cohorts will be enrolled and followed for 12 months: the first involving use of the VWING to salvage fistulae between 4-15mm deep that are difficult to cannulate, and the second involving use of the VWING to enable self-cannulation leading to self-care and home hemodialysis.

Lead investigator Dr. Sandip Mitra is a Consultant Nephrologist at Manchester Royal Infirmary in Manchester, England with strong focus on home hemodialysis. "We are excited to broaden our investigation of the VWING device to improve the use of arteriovenous fistulae, to include patients receiving dialysis at home," said Dr. Mitra. "VWING is an exciting innovation in vascular access to support assisted and self-cannulation.  It could play an important role in improving outcomes and empowering kidney patients on dialysis."

Receiving daily hemodialysis at home offers significant patient, clinical and cost benefits compared to dialysis at traditional dialysis centers.  Self-cannulation remains a significant barrier though, as many patients are uncomfortable cannulating themselves with dialysis needles.  "Vital Access is encouraged by the results of its studies and other clinical use of the VWING, including supporting home hemodialysis patients," said Duane Blatter, MD, Chief Medical Officer of Vital Access. "We believe VWING has the potential to make home dialysis achievable for many more patients."

Vital Access has already opened SAVE-2 clinical sites in the United Kingdom, and expects to add other sites in Western Europe and Canada in the near future. The company anticipates completing patient enrollment in 2014.