The FLEX-1 feasibility study was a prospective study of 33 patients to assess the safety and efficacy of creating percutaneous AV fistulas in hemodialysis patients. Study was conducted outside United States.
D.K. Rajan, A.A. Ebner, J.M. Rios, S. Desai,W.E. Cohn. Safety and efficacy of percutaneous autogenous arteriovenous fistula creation with the TVA FLEX system: expanded results beyond the pilot study. JVIR Vol.26, No 4, April 2015. Pgs 484 – 490.
Completed Clinical Studies
The FLEX-1 Study demonstrated that our technology can create AV fistulas for hemodialysis patients with 97% success and 96% usability for dialysis.
The Novel Endovascular Access Trial (NEAT) clinical study has completed enrollment of patients with chronic kidney disease to evaluate the safety and efficacy of the everlinQ System. NEAT has sites in Canada, Australia, and New Zealand.