Figulla Flex II ASD Occluder Procedure Pack - Cardiac occluder

Intended purpose

A system including an occluder (Figulla Flex II ASD) and a pusher (Flex Pusher-II). The occluder is an implant for closure of an ASD II (Atrial Septum Defect of the Secundum Type) and is deployed using the pusher via a minimally invasive catheter delivery system. The system is intended for patients with substantiated Left-Right-Shunt and a clear indication for closure of the defect.

Functional description

The occluder is a percutaneous transcatheter closure device consisting of two Nitinol wire mesh discs connected by a flexible waist. The design allows the device to be 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 atrial septal defect (ASD). It is deployed using the included pusher via a minimally invasive catheter delivery system.