Overview

This is a pivotal, interventional, prospective, single-arm, open-label, multi-site clinical investigation intended to support FDA clearance of the study device based on the safety and efficacy of the device in cannulating arteriovenous fistulas (AVFs) for hemodialysis procedures.

Eligibility

Inclusion

1. The subject's AVF is deemed uncannulatable because:
   1. The subject's anticipated cannulation zone(s) is/are >6mm in depth from the surface of the skin to the anterior wall of the access vein as confirmed by ultrasound within 8 weeks prior to device implantation (each zone, Arterial/Pull and Venous/Push, shall be assessed independently of one another for device placement):
      • Arterial/Pull Zone: _____ mm deep
      • Venous/Push Zone: _____ mm deep

OR

       2. The subject's dialysis unit (which includes an experienced cannulator) attests
          that repeated cannulation is not achievable in their clinic due to one of the
          following:
            -  Failed access attempt in a fistula that was previously approved for
               cannulation, or
            -  Unable to palpate the fistula such that cannulation is not possible
               without patient risk.

2. The access surgeon caring for the subject attests that the device is likely to be at

     least equivalent to other methods (such as venous transposition or suction-assisted
     lipectomy) that could make the AVF easier to access and reduce risk of cannulation
     infiltrations.

3. The subject has either a radio-cephalic, brachio-cephalic or transposed

brachio-basilic fistula.

Exclusion

1. The subject's access vein is >15mm in depth at either cannulation zones as measured by ultrasound within 8 weeks prior to device implantation.
   • Arterial/Pull Zone: _____ mm in depth
   • Venous/Push Zone: _____ mm in depth Note: these values should match inclusion criteria #1
2. Both bidimensional measurements in the subject's access vein have a diameter of

   <4mm, taken with a tourniquet in place or through manual compression to the outflow, as measured by ultrasound within 8 weeks prior to device implantation (cannulation zone specific - one zone does not affect the other's eligibility).

   • Arterial/Pull Zone: _____ x _____ mm in diameter
   • Venous/Push Zone: _____ x _____ mm in diameter
3. The subject has a flow rate of <550mL/min in the inflow artery proximal to the

   arterial anastomosis as measured by ultrasound within 8 weeks prior to device implantation.

   • Flow: _____ mL/min

4. The subject does NOT have a prescription to receive maintenance hemodialysis at least 2 times per week.
5. The subject's life expectancy is <1 year per the Investigator.
6. The subject does NOT have a signed and dated consent form.
7. The AVF is a non-transposed basilic or brachial vein outflow AVF.
8. The subject has high flow rates placing them at risk for heart failure and death at the discretion of the Investigator.
9. The subject has a known skin infection, hypersensitive skin, skin breakdown/erosion or skin allergies at the potential implant sites.
10. The subject has a known active systemic infection or positive blood cultures present.
11. The subject's AVF has undergone a major revision and at the discretion of the Investigator can impact fistula viability and device placement (such as DRIL or PTFE segment insertion, banding, aneurysm repair, etc.), or the subject has had an occurrence of and/or intervention for AV access stenosis or thrombosis within the past month (excluded to avoid unnecessary placement into an AVF with a high likelihood of failure).
12. The subject is <18 years of age.
13. The subject plans to become pregnant prior to their potential treatment date.
14. The subject has a body mass index >50kg/m2.
15. The subject has a known clinically significant bleeding or coagulation disorder, including but not limited to low platelet count (<50,000), hypercoagulable state (e.g., antithrombin IE deficiency, antiphospholipid or anticardiolipin antibodies, Factor V Leiden, circulating Lupus anticoagulant, current, heparin-induced thrombocytopenia, protein C or S deficiency, history of recurrent deep vein thrombosis not related to AV access).
16. The subject has an active malignancy.
17. The subject has a known or suspected allergy to titanium, aluminum, or vanadium.
18. The subject has had a significant cardiovascular event/intervention that makes them a poor surgical candidate such as myocardial infarction, angioplasty, or stent placement within 3 months of implantation.
19. The subject has had a significant peripheral vascular disease requiring a major intervention within the previous 12 months (in the target limb).
20. The subject has had a significant neurovascular event such as stroke or major intervention within the previous 12 months.
21. The subject has an uncontrolled major symptomatic medical problem per the Investigator.
22. The subject has a likelihood of poor protocol compliance due to mental incapacity, an inability to understand treatment instructions, or for any other reason in the opinion of the Investigator.
23. The subject is currently participating in another investigational drug or device investigation that could clinically interfere with the endpoints of this investigation.
24. The subject's conversion to home hemodialysis is anticipated at any point during their foreseeable participation in this investigation.