Quality-of-Life and Economic Data Presented for TVA Medical's everlinQ endoAVF System
May 30, 2018—TVA Medical, Inc. announced that findings from a health care analysis show that the company's catheter-based endovascular system for creating hemodialysis access offers quality-of-life benefits and cost savings compared with the traditional surgical approach in patients with end-stage renal disease (ESRD). The study comparing TVA Medical's everlinQ endovascular arteriovenous fistula (endoAVF) system with surgical arteriovenous fistula (AVF) creation was presented at ISPOR 2018, the International Society for Pharmacoeconomics and Outcomes Research global conference held May 19–23 in Baltimore, Maryland.
The retrospective analysis compared endoAVF patients from NEAT, the Novel Endovascular Access Trial, with propensity score–matched surgical AVF patients from the United State Renal Data System for 1 year after AVF creation.
According to the company, endoAVF patients compared with surgical AVF patients had approximately double the number of days with a functioning AVF for dialysis. In addition, those patients spent less time using a central venous catheter (83 vs 261 days), which lead to improvements in quality-adjusted life-years (QALYs; 0.574 vs 0.548 QALYs), needed fewer interventions (0.55 vs 4.38), and resulted in an average of 90% lower related costs ($1,271 vs $13,031) in the first year after receiving an AVF.
The everlinQ endoAVF system received European CE Mark approval in 2014 and Health Canada Medical Device License in 2016 for patients with ESRD. It is not available for sale in the United States and is currently under review by the US Food and Drug Administration, advised TVA Medical.