Fist Assist receives FDA Breakthrough Device designation for wearable vein dilation device
According to the company, the FA-1 is the world’s first wearable device for presurgical vein dilation that promotes arteriovenous fistula (AVF) creation in adult patients diagnosed with chronic renal failure whose preoperative assessment of the venous anatomy suggests that superficial arm vein or perforator vein size is inadequate for the creation of an AVF for haemodialysis access.