Subject provides written informed consent

Subject is male or female, with an age ≥ 18 years at date of enrollment.

Subject is willing to undergo all follow-up assessments.

Subject has a life expectancy ≥ 12 months.

Subject is undergoing chronic hemodialysis.

Subject has either a mature AVF or AVG in the arm.

Target lesion(s) involves a de novo stenotic or non-stented restenotic lesion.

Target lesion has ≥50% stenosis.

Target lesion(s) reference vessel diameter is between 5.0 mm and 14.0 mm

The Merit WRAPSODY AV Access Efficacy Study (WAVE)