New Data on TVA Medical’s everlinQ endoAVF System for Endovascular Hemodialysis Access Presented at LINC 2017
January 26, 2017—TVA Medical, Inc. announced that data from several studies on the company’s everlinQ endoAVF System, an endovascular technique to create hemodialysis access, were presented at LINC 2017, the Leipzig Interventional Course in Leipzig, Germany.
Tobias Steinke, MD, Chief of Vascular and Endovascular Surgery, Schoen Hospital, Dusseldorf, Germany provided the 1-year results of the Novel Endovascular Access Trial (NEAT). The study found that patients with end-stage renal disease treated with the everlinQ endoAVF System had high rates of fistula maturation (91%) and patency (84%), low thrombosis (10.5%), and minimal need for intervention (< 0.5 per patient).
“The promise of the everlinQ endoAVF System as a viable alternative to surgical AVF procedures, demonstrated in clinical trials and real-world cases, is very exciting,” commented Dr. Steinke in the company's announcement. “Patients deserve more options, and an endovascular solution is extremely appealing.”
TVA Medical describes the procedure as consisting of two thin, flexible magnetic catheters which are inserted into an artery and vein in the arm. Then, a small amount of radiofrequency energy connects the artery and vein to create the fistula. Once the catheters are removed, a brachial vein is coil-embolized to enable future dialysis.
Data from real-world experience with the system at two centers in Germany were also presented. The centers reported 100% procedural success and dialysis initiation within 56 days in 86% of patients.
Todd L. Berland, MD, Vascular Surgeon, NYU Langone Medical Center, New York, New York presented research on TVA Medical’s everlinQ 4 endoAVF system. This system is designed to allow access from other sites, such as the wrist, using a 4-F catheter system (rather than the standard 6-F). The data for this version showed a 97% procedural success with fistula maturation in 81% of patients within 30 days.
“This technology has the potential to revolutionize dialysis access. The clinical results using the 4-F everlinQ endoAVF System, which may benefit additional dialysis patients, are consistent with positive clinical results seen with the innovative 6-F system,” commented Dr. Berland in the company’s press release.
The final data presented were from a preclinical feasibility study using the everlinQ endoAVF System for treatment of peripheral artery disease. This research showed that the device can create an endovascular in situ vein bypass for below-the-knee revascularization without stents, couplers, or other foreign material.
The everlinQ endoAVF System has European CE Mark for end-stage renal disease patients who need hemodialysis. The system is not commercially available in the United States and is currently under review by the US Food and Drug Administration.