Device Dossier

WATCHMAN FLX™ LAA Closure Device with Delivery System - Cardiac occluder

Device Dossier for WATCHMAN FLX™ LAA Closure Device with Delivery System - Cardiac occluder (Cardiac occluder, Class III, sponsor Boston Scientific).…

Intended purpose

WATCHMAN FLX is intended to prevent thrombus embolization from the left atrial appendage and reduce the risk of life-threatening bleeding events in patients with non-valvular atrial fibrillation who are eligible for anticoagulation therapy or who have a contraindication to anticoagulation therapy.

Functional description

WATCHMAN FLX Device is a self-expanding nitinol structure with porous membrane on the proximal face. The Closure Device is constrained within the Delivery System until deployment in the LAA.WATCHMAN FLX Device is designed to be permanently implanted at or slightly distal to the ostium (opening) of the LAA to trap potential emboli before they exit the LAA.

TGA Public Summary