Device Dossier

Occlutech PDA Occluder / Occlutech Occlusions-Pusher - Cardiac occluder

Device Dossier for Occlutech PDA Occluder / Occlutech Occlusions-Pusher - Cardiac occluder (Cardiac occluder, Class III, sponsor Life Systems Medical).…

Intended purpose

The Occlutech PDA Occluder is an occlusion system, which is percutaneously implanted through a catheter intervention technique and intended for the non-surgical occlusion of Patent Ductus Arteriosus (PDA).

Functional description

The occluder and supplied pusher are connected by a threaded coupling and loaded via an appropriate loader into an introducing sheath, which has previously been positioned over a guidewire into the descending aorta. The PDA occluder and connected pusher are advanced through to the tip of the introducing sheath and slowly released. Once the position of the implant is confirmed by multiple angiograms, the introducing sheath is retracted so the shank of the implant unfolds inside the PDA.

TGA Public Summary