NEW ORLEANS -- Patients with failing kidneys may soon be able to get an arteriovenous fistula for hemodialysis without surgery a researcher reported here The Ellipsys Vascular Access System -- a single-catheter image-guided vascular access system for hemodialysis -- met its primary efficacy endpoint of brachial artery flow volume 500 ml min and vein diameter 4 mm in 86 92 out of 107 of patients exceeding the performance goal of 49 P 00001 The prospective single-arm study also found zero device-related adverse events at 90 days reported principal investigator Jeffrey E Hull MD director of the Richmond Vascular Center in Virginia at ASN Kidney Week 2017 The investigational device made by Avenu Medical enters the body through a vein and is directed into an artery at the location of an anastomosis Hull told MedPage Today The catheter then uses pressure and heat to fuse the artery and vein together and to cut an elliptical anastomosis The anastomosis produces an arteriovenous fistula in the same way as a sutured anastomosis he said The total process takes about 23 minutes and can be performed in the office without going to the hospital The ease and convenience of the procedure should improve the patient experience and improve the quality of care for patients with end-stage renal disease Hull said during his presentation Kelly Hyndman PhD of the University of Alabama at Birmingham who was not involved with the study told MedPage Today that maturations and these surgeries are such a prevalent problem If a little device goes in and then is out in 23 minutes and the patient has this really nice no-suture osmosis if its true its amazing Hull and colleagues enrolled 107 patients at five outpatient office-based labs throughout the country Patients underwent ultrasound-guided anastomosis creation between the proximal radial artery and perforating vein with the Ellipsys Vascular Access System followed by separate maturation procedures The researchers created arteriovenous fistulas with fused anastomoses in 95 N 102 of patients Maturation procedures included anastomotic balloon dilation in 72 77 107 brachial vein embolization in 32 34 107 cubital vein ligation in 27 29 107 and surgical transposition in 26 28 107 Hull reported that cumulative patency was 961 937 and 91 at 90 180 and 360 days respectively Functional patency was 984 984 and 923 at 90 180 and 360 days The target dialysis vein was the cephalic basilic and brachial veins in 74 73 99 24 24 99 and 2 2 99 respectively and two-needle dialysis was achieved in 88 71 81 of patients on hemodialysis at an average of 1131 days Hull noted that the process is similar to common procedures such as obtaining venous and arterial access with ultrasound and requires similar skills Percutaneous creation of arteriovenous fistulas can also be completed by endovascular surgeons which will greatly increase the number of patients who receive this procedure he added The device received a European CE Mark in 2016 and is currently under FDA review It is difficult to predict when FDA will grant market clearance Hull told MedPage Today The device is made by Avenu Medical Inc Hull reported no financial disclosures of interest