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Abbott Announces CE Mark for its Amplatzer Steerable Delivery Sheath, Enabling New Capabilities in Treating AFib

"Abbott's Amplatzer Amulet has long been the LAA occlusion device of choice in Europe and Canada to reduce the risk of stroke and eliminate the need for blood thinning medication in patients with atrial fibrillation," said Réda Ibrahim, M.D., Montréal Heart Institute, who completed one of the first global procedures with the new system. Jacqueline Saw, M.D., Vancouver General Hospital, who completed additional first procedures, added, "Physicians performing occlusion procedures on the LAA can now easily and precisely place the device in a broad range of anatomies with an enhanced delivery system that shortens procedure time and enhances efficiency."


To improve physician ease-of-use, the Amplatzer Steerable Delivery Sheath features bi-directional steering and an "auto-lock" setting for more accurate alignment with the LAA. The sheath also includes a hemostasis valve designed to stabilize blood flow and minimize blood loss during the procedure. The new design additionally reduces the need for catheter manipulation or exchanges, which can slow down procedure time or cause further blood loss.


"This innovation advances the performance of our Amplatzer Amulet device and offers patients a much-needed treatment option to help manage stroke risk from atrial fibrillation," said Michael Dale, senior vice president of Abbott's structural heart business. "At Abbott, we are continually looking for new and better ways to address structural heart diseases, and this approval is another step forward in helping people achieve better health."


For more information on the Amplatzer Amulet LAA Occluder, please visit:


The Amplatzer Steerable Delivery Sheath and Amplatzer Amulet LAA Occluder are not approved for use in the U.S.  


About Abbott:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our

portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses

and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

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Last Updated: 08-Jun-2021