Abbott’s Amplatzer Steerable Delivery Sheath Approved in Europe and Canada for LAA Closure

June 7, 2021—Abbott announced it has received CE Mark approval and Health Canada approval for its Amplatzer steerable delivery sheath, which is used with the company’s Amplatzer Amulet left atrial appendage (LAA) occluder. The device is now available in Europe and Canada.

Réda Ibrahim, MD, of Montréal Heart Institute in Montréal, Canada, and Jacqueline Saw, MD, of Vancouver General Hospital in Vancouver, Canada, also completed some of the first procedures with the system.

In the company’s announcement, Dr. Ibrahim commented, “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.”

Dr. Saw 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.”

According to the company, the Amplatzer Amulet was developed specifically for minimally invasive LAA occlusion procedures to treat patients diagnosed with atrial fibrillation who are at risk of ischemic stroke.

Amplatzer steerable delivery sheath is designed to improve physician ease-of-use with bidirectional steering and an “auto-lock” setting for more accurate alignment with the LAA. The sheath also includes a hemostasis valve to stabilize blood flow and minimize blood loss during the procedure. The new design reduces the need for catheter manipulation or exchanges.

The Amplatzer steerable delivery sheath and Amplatzer Amulet LAA occluder are not approved for use in the United States, advised Abbott.