Figulla Flex II PFO Occluder Procedure Pack - Cardiac occluder

Intended purpose

A system including an occluder (Figulla Flex II PFO) and a pusher (Flex Pusher-II). The occluder is a cardiac implant to close defects of type Patent Foramen Ovale (PFO) and is deployed using the pusher via a minimally invasive catheter delivery system.

Functional description

The occluder is a percutaneous, transcatheter, atrial septal defect closure device, consisting of a Nitinol wire mesh with two retention discs, connected through a thin flexible ridge. The device is pulled into a delivery sheath and reshaped once it is released. When correctly positioned and firmly attached on both sides of the septum, it conforms to the septal wall and closes a present defect. It is deployed using the included pusher via a minimally invasive catheter delivery system.