The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions

A Prospective, Single Arm, Multi-Center Study to Assess Performance of the Pathway PV Atherectomy System During Percutaneous Peripheral Vascular (PV) Interventions

The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in peripheral vasculature.

This is a prospective, single arm, multi-center study to obtain safety and performance data for the Pathway PV Atherectomy System when used as a primary or adjunctive therapy for percutaneous intervention to remove atherosclerotic disease, debris, and thrombus from the lower limb peripheral vasculature.

Inclusion Criteria:

• Documented symptomatic atherosclerotic peripheral vascular disease
• Target lesion(s) is/are located in a superficial femoral, popliteal and/or infrapopliteal arteries
• The patient has been informed of the nature of the study and has provided informed consent
• The patient agrees and has capability to meet study requirements and be present at the follow-up clinic visits

Exclusion Criteria:

• Target lesion is located in the iliac artery.
• Target lesion stenosis is < 70%.
• Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
• Patient is unable to participate for the duration of the study.
• Patient is currently participating or has participated in a study with another investigational medical device or medication.