CE Mark granted to st Jude Medical for Amplatzer LAA Occluder

European CE Mark approval is granted to St. Jude Medical for its Amplatzer Amulet Left Atrial Appendage Occluder. The Amulet device is used to close the left atrial appendage (LAA) in patients diagnosed with non-valvular atrial fibrillation (AF). According to research, AF leads to an increased risk for stroke. Sealing off the LAA helps prevent the risk of blood clot formation and release, potentially reducing the risk of stroke. The next-generation percutaneous transcatheter device leverages the design and clinical success of the original Amplatzer Cardiac Plug with additional features allowing treatment of a wider range of appendage anatomies.

The Amplatzer Amulet Left Atrial Appendage Occluder is not yet approved for use in the United States.