AVENU MEDICAL, INC. AMI6050 Ellipsys Vascular Access System

The Ellipsys Vascular Access System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.The main components of the Ellipsys Vascular Access System are the Ellipsys Catheter, the Ellipsys Crossing Needle, and the Ellipsys Power Controller. The Crossing Needle and Catheter are single-use, sterile disposables that are packaged together, and referred to as the Ellipsys Vascular Access Kit. The Ellipsys Power Controller is a reusable, non-sterile portable electronic console that is packaged and provided separately.