Device Category Dossier

Catheter, angioplasty, atherectomy

Device Category Dossier for Catheter, angioplasty, atherectomy. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Percutaneous rotational coronary atherectomy systems remove plaque from partially occluded vessels using a rotating catheter, often with real-time optical coherence tomography assistance to guide intervention. These devices are used to treat calcific coronary artery disease in patients with single or multiple vessel atherosclerotic disease, restenosis after prior coronary intervention, or lesions less than 25 mm in length.