TVA Medical has provided clinical updates involving its everlinQ endoAVF system at the 2017 Leipzig Interventional Course (LINC; 24–17 January, Leipzig, Germany).
Scientific data were presented this week at LINC including a main arena discussion by Tobias Steinke, chief of Vascular and Endovascular Surgery, Schoen Hospital, Dusseldorf, Germany.
“The promise of the everlinQ endoAVF system as a viable alternative to surgical arteriovenous fistulae procedures, demonstrated in clinical trials and real-world cases, is very exciting,” states Steinke. “Patients deserve more options, and an endovascular solution is extremely appealing.”
One-year data presented from the single-arm, prospective, multicentre Novel Endovascular Access Trial (NEAT) study in patients with end-stage renal disease showed high fistula maturation (91%); high patency (84%); low thrombosis (10.5%); and low interventions (0.46 per patient year).
At two centres in Germany reporting real-world experience with the everlinQ endoAVF system, physicians achieved 100% procedural success; dialysis initiation in 86% of patients within 56 days; and a low rate of interventions.
In addition, data were reported from a preclinical feasibility study using the everlinQ endoAVF system for peripheral artery disease. The cadaver study demonstrated the feasibility of creating an endovascular in situ vein bypass—in place of a surgical distal autologous vein bypass—for below-the-knee revascularisation, without stents, couplers or other foreign material.
Results were also presented from a study evaluating the everlinQ 4 endoAVF system, which is designed to enable other access sites like the wrist, using a 4F (vs. 6F) catheter system. The prospective, single arm, single-centre trial showed 97% procedural success and fistula maturation in 81% of patients within 30 days.
“This technology has the potential to revolutionise dialysis access. The clinical results using the 4F everlinQ endoAVF System, which may benefit additional dialysis patients, are consistent with positive clinical results seen with the innovative 6F system,” comments Todd L Berland, vascular surgeon, NYU Langone Medical Center, New York City, USA.
The everlinQ endoAVF System has European CE mark and Health Canada Medical Device License for end-stage renal disease patients who need haemodialysis, and commercialisation has begun at select centres in Europe. It is not commercially available in the USA and is currently under review by the US Food and Drug Administration.
Each year approximately three million people worldwide with end stage renal disease are treated with haemodialysis. However, the first step, creating a viable access in the arm, is often a significant clinical challenge. The current standard approach, surgical arteriovenous fistulas, are associated with high failure rates, often as high as 60% and they require frequent revisions, resulting in increased morbidity and unnecessary costs.