FDA approves EverlinQ EndoAVF System for chronic kidney disease.- TVA Medical.

TVA Medical announced it has received FDA De Novo marketing authorization of the everlinQ endoAVF System. This minimally invasive technology uses magnetic catheters and radiofrequency energy to create an arteriovenous fistula (AVF) for hemodialysis access without open surgery in the management of chronic kidney disease. The FDA marketing authorization enables use of the everlinQ endoAVF System as a Class II medical device in the ulnar artery and ulnar vein, to create an endoAVF for hemodialysis use in properly indicated patients.

Data from four clinical studies using the everlinQ endoAVF System demonstrated 97 percent procedural success; 88 percent fistula maturation (suitable for dialysis) at three months; and 75 percent successful cannulation at six months with minimal need for re-intervention. The everlinQ endoAVF System was reviewed by the FDA through the De Novo premarket review pathway, a regulatory process for some new medical devices that are low to moderate risk and have no legally marketed predicate device to base a determination of substantial equivalence. The everlinQ endoAVF System first received European CE Mark in 2014 and Health Canada Medical Device License in 2016 for ESRD patients.