LEIPZIG, Germany, Jan. 26, 2017 /PRNewswire/ -- TVA Medical, Inc. today announced several clinical updates involving its everlinQ™ endoAVF System, an innovative endovascular technique to create hemodialysis access without open surgery, with other potential clinical applications. The everlinQ endoAVF System has European CE Mark and Health Canada Medical Device License for end-stage renal disease (ESRD) patients who need hemodialysis, and commercialization has begun at select centers in Europe. It is not commercially available in the United States and is currently under review by the U.S. Food and Drug Administration.
Scientific data from the everlinQ endoAVF System were presented this week at the Leipzig Interventional Course (LINC) 2017 in Leipzig, Germany, including a main arena discussion today by Dr. 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 AVF procedures, demonstrated in clinical trials and real-world cases, is very exciting," stated Steinke. "Patients deserve more options, and an endovascular solution is extremely appealing."
One-year data presented from the single-arm, prospective, multi-center Novel Endovascular Access Trial (NEAT) study in patients with ESRD showed high fistula maturation (91 percent); high patency (84 percent); low thrombosis (10.5 percent); and low interventions (0.46 per patient year).
At two centers in Germany reporting real-world experience with the everlinQ endoAVF System, physicians achieved 100 percent procedural success; dialysis initiation in 86 percent 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 (PAD). 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 revascularization, 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 4 French (vs. 6 French) catheter system. The prospective, single arm, single center trial showed 97 percent procedural success and fistula maturation in 81 percent of patients within 30 days.
"This technology has the potential to revolutionize dialysis access. The clinical results using the 4Fr everlinQ endoAVF System, which may benefit additional dialysis patients, are consistent with positive clinical results seen with the innovative 6Fr system," commented Todd L. Berland, MD, vascular surgeon, NYU Langone Medical Center, New York, N.Y.
Each year approximately 3 million people worldwide with 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 rates, often as high as 60 percent,2 and they require frequent revisions, resulting in increased morbidity and unnecessary costs.3
"Our focus is the development of innovative endovascular technologies in areas of high unmet clinical need," said Adam L. Berman, president and CEO of TVA Medical. "We are fortunate to partner with top global clinical experts as we continue to demonstrate the strong potential for the everlinQ endoAVF System platform."
About the everlinQ endoAVF System The everlinQ endoAVF System is designed to create an AV fistula 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.
About TVA Medical TVA Medical, Inc., headquartered in Austin, Texas, is developing minimally invasive therapies for end-stage renal disease and other potential applications, such peripheral vascular disease. More information is available at 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.