TVA Medical’s everlinQ endoAVF System exhibits positive Clinical results
It is noteworthy that TVA Medical‘s everlinQ endoAVF System exhibited positive Clinical results using the everlinQ endoAVF System. An international meta-analysis of clinical experience in patients who received an endovascular arteriovenous fistula (endoAVF) for hemodialysis access was presented today at Leipzig Interventional Course (LINC) 2018. Data was analysed from 236 patients with end- stage renal disease at 28 centers across seven countries.
The everlinQ endoAVF System sought European CE Mark in 2014 and Health Canada Medical Device License in 2016 for ESRD patients. It is currently underway for approval from FDA.
According to Dr. Steinke said “Our meta-analysis from four clinical studies and real-world experience across three continents supports the use of the everlinQ endoAVF System as a valuable hemodialysis access option without open surgery.”
The meta-analysis included four clinical studies with pooled efficacy and safety data from 157 and 125 patients, respectively, using both the 4 Fr or 6 Fr versions of the everlinQ catheter system, as well as data from 79 commercial cases, using the 6 Fr catheter system.
Dr. Robert Jones, Consultant Interventional Radiologist at Queen Elizabeth Hospital in Birmingham, England, presented on a recorded patient case he performed using the everlinQ 4 endoAVF System. The everlinQ 4 endoAVF System, which received CE Mark in 2017, uses a 4 Fr catheter system to create an endovascular fistula.