Device Dossier

Aveir Delivery Catheter Model LSCD111 - Catheter, intravascular, guiding

Device Dossier for Aveir Delivery Catheter Model LSCD111 - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Abbott…

Intended purpose

The Aveir Delivery Catheter is intended to be used in the peripheral vasculature and the cardiovascular system to deliver and manipulate an leadless pacemaker (LP). Delivery and manipulation include implanting an LP within the target chamber of the heart.

Functional description

The Aveir Delivery Catheter includes a steerable delivery catheter, an integrated guiding catheter with a distal protective sleeve designed to protect an attached Leadless Pacemaker's fixation helix and electrode, and a valve bypass tool to dilate the haemostasis valve of the introducer sheath for advancing the system into the femoral vein.

TGA Public Summary