Twelve-Month NEAT Results Published for TVA Medical's everlinQ endoAVF System
June 15, 2017—TVA Medical, Inc. announced that 12-month results from the Novel Endovascular Access Trial (NEAT) were published online by Charmaine E. Lok, MD, et al in American Journal of Kidney Diseases.
NEAT evaluated the company's everlinQ endoAVF system, which is designed to create an arteriovenous fistula (AVF) for hemodialysis access in an endovascular procedure using catheter-delivered radiofrequency energy. The everlinQ endoAVF system has received European CE Mark approval and a Health Canada Medical Device License. It is not approved for use in the United States.
According to TVA Medical, the NEAT data demonstrated the potential benefit of the everlinQ endoAVF system to create hemodialysis access as an alternative to traditional open surgery.
The NEAT study is a single-arm, prospective, multicenter study conducted at nine sites in Canada, Australia, and New Zealand. The study measured safety, efficacy (defined as the endoAVF being physiologically suitable for dialysis within 3 months), functional usability of the endoAVF to provide dialysis with two-needle cannulation, and primary and secondary patencies.
Dr. Lok, who is the Principal Investigator of the study, commented in the company's press release, “The NEAT results show that the everlinQ endovascular approach can produce fistulas for hemodialysis, with an acceptable safety profile. This unique approach offers clinicians and chronic kidney disease patients another option for fistula creation that is minimally invasive.” Dr. Lok is Medical Director of the Hemodialysis Program at University Health Network-Toronto General Hospital and Senior Scientist at the Toronto General Hospital Research Institute in Toronto, Ontario.
TVA Medical also advised that Dr. Lok, along with Shuo Yang, PhD, et al, recently published findings from a comparison of postcreation procedures and costs between surgical and an endovascular approach to AVF creation in The Journal of Vascular Access (2017;18[suppl. 2]:8–14). The study 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 with patients who received a surgical AVF. The propensity score–matched comparison to surgical AVF was calculated using a 5% random sample from Medicare Standard Analytical Files.