WASHINGTON (dpa-AFX) - St. Jude Medical Inc. (STJ) announced European CE Mark approval of its AMPLATZER Amulet Left Atrial Appendage Occluder. The Amulet device is used to close the left atrial appendage or LAA in patients diagnosed with non-valvular atrial fibrillation or AF. Sealing off the LAA helps prevent the risk of blood clot formation and release, potentially reducing the risk of stroke, the company said.
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. Research demonstrates that in AF patients, nearly 90 percent of all cardiac blood clots form in the LAA. The company said this next-generation occlusion device is built with a longer lobe and waist than prior versions to allow for easier placement.
The AMPLATZER Amulet device is offered in eight sizes to accommodate varying anatomies. Further, the device is pre-loaded into the delivery catheter, simplifying device preparation and ultimately streamlines the entire procedure for the physician. The AMPLATZER Amulet Left Atrial Appendage Occluder is not yet approved for use in the U.S.
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