This is an early feasibility, pre-market, prospective, interventional, single-arm, non-randomized / open-label study intended to support a future pivotal IDE study for eventual FDA clearance of the study device based on the safety and efficacy of the device in cannulating arteriovenous fistulas (AVFs) for hemodialysis procedures.
Subject is an adult patient ≥ 18 years of age.
Subject with the ability to attend "in-center" hemodialysis.
Subject has a requirement of hemodialysis 3 times/week.
Subject has an AVF that was determined to be mature by standard clinical definition
Subject has an existing arteriovenous graft.
Subject has any active infection within the past 90 days.
Subject is currently receiving or planning home hemodialysis.
Subject has a distorted anatomy and/or local vascular injury.