Device Dossier

Catheter, angioplasty, atherectomy

Device Dossier for Catheter, angioplasty, atherectomy (Catheter, angioplasty, atherectomy, Class IIb, sponsor Diverse Devices). ARTG record, intended…

Intended purpose

he Pantheris system (Pantheris) is comprised of the 1) Pantheris catheter (catheter), and the Lightbox HS Console (Lightbox). A sterile drape (sterile drape) is used to separate the sterile and non-sterile system interfaces. The Pantheris system is intended for the removal of plaque (atherectomy) from partially occluded vessels in the peripheral vasculature using real- time optical coherence tomography (OCT) assisted orientation during catheter intervention. OCT is used as an adjunct to fluoroscopy and is provided through the Lightbox.

TGA Public Summary