Austin, Texas-based TVA Medical Inc. released positive results from a clinical study evaluating the everlinQ System for hemodialysis without the use of traditional open surgery. The clinical results of TVA Medical’s everlinQ System were published online in the April 2015 issue of Journal of Vascular and Interventional Radiology.
The everlinQ System is an investigational device that creates an AVF using a minimally-invasive approach. In the procedure, two thin, flexible magnetic catheters are inserted into an artery and vein in the arm. A small burst of radiofrequency energy is used to connect the artery and vein to create the fistula, and the catheters are removed.
Of 33 study patients, technical procedural success was achieved in 97% of cases, and 96% of study patients had a usable and unobstructed AVF at six months, with minimal need for additional intervention. The average time to a usable AVF for hemodialysis was 58 days.
“The results demonstrate that the everlinQ System can create AVFs that are usable for dialysis and resist closure,” said Dheeraj Rajan, M.D., an investigator of the FLEX study and Head of Vascular and Interventional Radiology at University of Toronto, Canada. “I am optimistic as we continue to study the impact the product has on infections, patient discomfort, the need for additional interventions, and health care costs.”
The everlinQ System has been studied outside the United States and has received CE mark. The product is not currently available in the United States and has not been evaluated by the U.S. Food and Drug Administration.