Brigham Research Institute (BRI) - Brigham and Women's Hospital

Eligibility

Eligible Ages

Over 18 Years

Eligible Genders

All

Accepts Healthy Volunteers

No

Criteria

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.