Device Dossier

AnchorMan Left Atrial Appendage Closure System - Cardiac occluder

Device Dossier for AnchorMan Left Atrial Appendage Closure System - Cardiac occluder (Cardiac occluder, Class III, sponsor Microport Crm). ARTG record,…

Intended purpose

The AnchorManTM Closure System is intended for percutaneous, transcatheter closure of the left atrial appendage to prevent thrombus embolization from the left atrial appendage. It is intended to prevent thrombus embolization from the left atrial appendage in patients with non-valvular atrial fibrillation (NVAF, AF in the absence of moderate/severe mitral stenosis or those with mechanical prosthetic heart valve(s)) who have a CHA2DS2-VASc score ≥2, and eligible or ineligible for anticoagulation therapy.

TGA Public Summary