Atherectomy and Drug Coated Balloon for the Treatment of Arterio-Venous Graft Stenosis

Inclusion Criteria: * Male or non-pregnant, non-breastfeeding female ≥18 years of age; * Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits; * Target lesion must be a mature arteriovenous graft presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines; * Subject has a target lesion at the venous anastomosis of the AVG; * Successful crossing of the stenosis; * Each lesion length is ≤20mm, which may include tandem lesions that are ≤20mm apart Exclusion Criteria: * Subject is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this study; * Subject has a non-controllable allergy to contrast; * Subject has more than 3 lesions in the access circuit requiring intervention; * Target lesion diameter \>10mm; * A thrombosed access or an access with a thrombosis treated ≤30 days prior to the index procedure; * Prior surgical interventions of the access site ≤30 days before the index procedure; * Target lesion is located within a bare metal or covered stent.