AUSTIN, Texas, June 15, 2017 /PRNewswire/ -- TVA Medical, Inc. today announced the online publication of positive results from the Novel Endovascular Access Trial (NEAT) evaluating its everlinQTM endoAVF System. The 12-month data published online in the American Journal of Kidney Diseases (AJKD), the official journal of the National Kidney Foundation, demonstrate the potential benefit of the novel approach to create hemodialysis access as an alternative to traditional open surgery.
The everlinQ endoAVF System is designed to create an arteriovenous fistula (AVF) for hemodialysis access in an endovascular procedure using catheter-delivered radiofrequency energy.
"The NEAT results show that the everlinQ endovascular approach can produce fistulas for hemodialysis, with an acceptable safety profile," said NEAT Principal Investigator Charmaine E. Lok, MD, FRCPC, medical director of the Hemodialysis Program, University Health Network-Toronto General Hospital and senior scientist at the Toronto General Hospital Research Institute in Toronto. "This unique approach offers clinicians and chronic kidney disease patients another option for fistula creation that is minimally invasive."
The NEAT study is a single-arm, prospective, multi-center study conducted at nine sites in Canada, Australia and New Zealand. The study measured safety, efficacy (defined as endoAVF physiologically suitable for dialysis within three months), functional usability of the endoAVF to provide dialysis with 2-needle cannulation, and primary and secondary patencies.
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 clinical challenge.
"There is a significant clinical need to reliably deliver a working AV fistula for patients who need hemodialysis," said Adam L. Berman, president & chief executive officer of TVA Medical. "We are honored to have this important study published in the esteemed AJKD and thank the physician investigators and patients for their dedication to studying this advancement for dialysis patients."
In addition, an article published this spring in The Journal of Vascular Access showed that patients who received an endoAVF in the NEAT study required fewer post-endoAVF interventions, with a potential first-year medical cost savings per patient of $11,240, compared to patients who received a surgical AVF. The propensity score-matched comparison to surgical AVF was calculated using a 5 percent random sample from Medicare Standard Analytical Files.
About the everlinQ endoAVF System
The everlinQ endoAVF 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 everlinQ endoAVF system has European CE Mark and Health Canada Medical Device License. It is not approved for use in the United States.
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
SOURCE TVA Medical, Inc.