Device Category Dossier

Atherectomy peripheral angioplasty system

Device Category Dossier for Atherectomy peripheral angioplasty system. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Peripheral atherectomy devices consist 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 plaque. These devices are intended to restore blood flow by removing atherosclerotic calcified and non-calcified plaque from peripheral arteries in patients with occlusive atherosclerotic disease.