Atherectomy peripheral angioplasty system

Intended purpose

An assembly of devices designed for the intraluminal excision of plaque from the peripheral vasculature; it is intended to perform an endarterectomy (removal of plaque deposits from atherosclerotic arteries). It typically consists of a long, thin, flexible catheter that is percutaneously introduced into the peripheral vasculature, and a power-driver cutting or abrasive head used to mechanically disrupt the plaque. This device is not intended of use in the coronary, carotid, iliac or renal vasculature.