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June 8, 2021

Abbott obtains CE mark for steerable delivery system for LAA occlusion

Approved for use with Abbott’s Amplatzer Amulet LAA Occluder, the system is only available in Europe and Canada.

Abbott has obtained CE mark approval for its Amplatzer Steerable Delivery Sheath for left atrial appendage (LAA) occlusion (closure) procedures to treat atrial fibrillation (AF) patients who are at increased risk of ischemic stroke.

The minimally invasive device, which has also received approval from Health Canada, is indicated to be used along with Abbott’s Amplatzer Amulet LAA Occluder.

The Amplatzer Steerable Delivery Sheath has bi-directional steering and an ‘auto-lock’ feature to offer physicians better flexibility and accurate positioning when placing the Amplatzer Amulet.

Furthermore, the sheath has a haemostasis valve to stabilise the blood flow and reduce blood loss during procedures.

The sheath’s design further lowers the requirement for catheter adjustments or exchanges, which could delay procedures or cause additional blood loss.

The Amplatzer Steerable Delivery Sheath is currently available only in Europe and Canada and not approved in the US.

Abbott structural heart business senior vice-president Michael Dale said: “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.

“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.”

The most common sustained cardiac arrhythmia, AF develops when the upper chambers of the heart, the atria, contract erratically and quickly, which causes loss of coordination with the lower ventricle chambers.

The LAA is a small pocket joined to the left atrium. In AF patients, it can allow blood to accumulate and lead to the formation of clots, which can travel to the brain and cause a stroke.

For AF patients who cannot take blood-thinning therapies long term, doctors can carry out closure procedures, in which an occlusion device is implanted in the heart to seal off the LAA.

Last month, Abbott received CE mark for its new transcatheter aortic valve implantation (TAVI) system, Navitor, to treat severe aortic stenosis patients with high or extreme surgical risk in Europe.

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