Vital Access, a provider of surgical and interventional technologies, has launched SAVE-2 post-market clinical follow-up study to investigate the benefits of VWING vascular needle guide for self-cannulation.
The SAVE-2 study follows the company’s successful SAVE study, which demonstrated the benefits of the VWING vascular needle guide in restoring vascular access to hemodialysis patients with uncannulatable and deep arteriovenous fistulae.
SAVE-2 study will enroll around 60 patients under two patient cohorts and followed for 12 months.
The first patient cohort will involve the use of VWING to salvage fistulae between 4-15mm deep that are difficult to cannulate, while the second cohort second will involve the use of VWING to enable self-cannulation leading to self-care and home hemodialysis.
Vital Access chief medical officer Dr Duane Blatter noted the company is encouraged by the results of its studies and other clinical use of the VWING, including supporting home hemodialysis patients.
"We believe VWING has the potential to make home dialysis achievable for many more patients," Dr Blatter added.
The company opened clinical sites for SAVE-2 study in the UK and anticipates adding other sites in Western Europe and Canada shortly.
Vital Access expects to complete the patient enrollment for the SAVE-2 study in 2014.