• Subject is willing and able to provide consent before any study-specific tests or procedures are performed and agree to attend all required follow-up visits.

• Subject at least 18 years of age.

• Subject has a native AV fistula created ≥ 60 days prior to enrollment.

• The target AVF has undergone successful dialysis for at least 8 of 12 sessions during a four-week period prior to enrollment.

• Subjects on stable dialysis has all of the following criteria meet.

‣ No significant decrease in blood pressure during dialysis during a four-week period prior to enrollment

⁃ No significant edema

⁃ No signs of heart failure

• Target lesion is located between the arteriovenous anastomosis and axillosubclavian junction.

• Note: If the lesion is in the anastomosis, the treatment may be delivered up to 2 cm upstream on the arterial side. Note: If the lesion is in the cephalic arch, the treatment may be delivered up to 2 cm into the subclavian vein.

• Angiographic evidence that target lesion consists of a de novo and/or non-stented restenotic lesion with ≥ 50% stenosis by visual estimate.

• Most recent standard PTA (ie. non-drug coated) treatment must be \> 3 months prior to enrollment and most recent DCB treatment must be \> 6 months prior to enrollment.

• A target lesion with total lesion length up to 130 mm by visual estimate. Note: Tandem (or adjacent) lesions may be enrolled provided they meet all of the following criteria:

∙ Separated by a gap of ≤ 30mm (3 cm).

‣ Total combined lesion length, including 30 mm gap, is ≤ 130 mm.

‣ Able to be treated as a single lesion.

⁃ Reference vessel diameter ≥ 4.0 mm and ≤ 8.0 mm by visual estimate.

⁃ Subject underwent successful crossing of the target lesion with the guide wire and pre-dilatation with only high pressure PTA balloon(s) defined as:

• Residual stenosis of ≤ 30% AND.

∙ Absence of a flow limiting dissection (Grade ≥ C) or perforation.