Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM as a Single-Site Vascular Access Device for Hemodialysis Procedures

Inclusion criteria

• 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 with ≥ 3 months stable in center hemodialysis with >90 days use of an AV fistula cannulated with 2 needles with no evidence of stenosis or thrombosis.
• Subject has an AVF that meets all of the following Rule of 5s:

• Flow ≥ 500 mL/min
• Diameter ≥ 5 mm
• Depth ≤ 5 mm from the skin surface
• Length ≥ 5 cm usable for cannulation
• Subject does not have any established lesions or stents in the access circuit as confirmed by ultrasound.
• Subject dialyzes at a center that can confirm 30-day data collection on cannulations and is willing to cooperate in performing real-time assessments and record keeping per Sponsor requirements, to assure subject safety requirements.

Exclusion criteria

• 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.
• Subject has a change in blood thinner regimen in the last 60 days.
• Subject has any unstable medical or psychiatric conditions likely to impair their ability to participate in the study.
• Subject has a known history of clinically significant IV drug use.
• Subject is a pregnant or nursing woman, or anticipates pregnancy in the next 3 months.
• Subject is enrolled in another study that could confound the results of this study, without documented pre-approval.
• Subject has a known allergy to plastics.
• Subject is unwilling to sign the study's consent form.
• Subject has a life expectancy of less than 12 months.