October 4, 2017 — TVA Medical Inc. announced that its everlinQ 4 endoAVF System has received CE Mark in the European Union. The technology uses a 4 French catheter system with enhanced visual indicators to create hemodialysis access using an endovascular technique without open surgery.
In a prospective, single arm, single-center study evaluating the everlinQ 4 endoAVF System, 97 percent of endovascular arteriovenous fistula (endoAVF) procedures were successful, and fistula maturation was achieved in 83 percent of patients.
Tobias Steinke, M.D., chief of vascular and endovascular surgery, Schön Klinik, Düsseldorf, Germany,performed the first case in Europe using the everlinQ 4 System. “The new system with smaller profile catheters and radiopaque visual indicators was extremely easy to use,” he said. “This new approach streamlines the procedure for providing patients a functional AV fistula without open surgery.”
Each year approximately 3 million people worldwide with end-stage renal disease (ESRD) are treated with hemodialysis.1 However, the first step, creating a viable access in the arm, is often a significant clinical challenge. The current standard approach, surgical arteriovenous fistulas (AVFs), are associated with high failure rates2, and may require frequent revisions, impacting patient quality of life and resulting in unnecessary costs.3
The everlinQ endoAVF System, using the 4 French or 6 French catheter system, is designed to create an AVF for hemodialysis access using an endovascular approach. In the procedure, two thin, flexible magnetic catheters are inserted into an artery and vein in the arm. A small amount of radiofrequency energy is used to connect the artery and vein to create the fistula. The catheters are then removed and a brachial vein is coil-embolized, enabling future dialysis.
The 6 French everlinQ endoAVF System previously received CE marking for ESRD patients who need hemodialysis. The 6 French system also has Health Canada Medical Device License. TVA Medical is pursuing U.S. Food and Drug Administration (FDA) clearance of the everlinQ endoAVF System and the technology is not currently available for use in the United States.
For more information: www.tvamedical.com
1 Liyanage, et al. Lancet, 2015. 10.1016/S0140-6736
2 Al-jaishi, et al. Am J Kidney Dis 2014;63:464-78.
3 Lok. Clin J Am Soc Nephrol 2: 1043-1053, 2007.