Device Dossier

WATCHMAN TruSteer Access System - Cardiac occluder delivery kit

Device Dossier for WATCHMAN TruSteer Access System - Cardiac occluder delivery kit (Cardiac occluder delivery kit, Class III, sponsor Boston Scientific).…

Intended purpose

The WATCHMAN TruSteer™ Access System is intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

Functional description

The WATCHMAN TruSteer Access System (Access Sheath and Dilator) provides access to the left atrium and serves as a conduit for placement of a WATCHMAN FLX family Closure Device with Delivery System, as well as applicable ancillary devices, into the left atrium. The Dilator is inserted into the femoral vein and provides a means to track the Access Sheath over a guidewire and cross the inter-atrial septum.

TGA Public Summary