EU clears St. Jude's updated Amplatzer occluder

St. Jude Medical has received European CE Mark approval of its Amplatzer Amulet left atrial appendage (LAA) occluder device, which is used to close the LAA in patients diagnosed with nonvalvular atrial fibrillation (AF).

The company said that 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 LAA is a tube-shaped appendage connected to the left atrium of the heart that can potentially hold static blood during an episode of AF, increasing the likelihood of clot formation. Self-expanding and made of braided nitinol mesh, consistent with the entire family of Amplatzer devices, the Amulet occluder works by blocking the LAA at its opening.

This next-generation occlusion device is built with a longer lobe and waist than previous versions, according to the St. Paul, Minn.-based St. Jude. The Amplatzer Amulet device is offered in eight sizes to accommodate varying anatomies. Additionally, the device is preloaded into the delivery catheter.

The Amplatzer Amulet left atrial appendage occluder is not yet approved for use in the U.S.