Abbott’s Amplatzer Steerable Delivery Sheath Introduced in the United States

April 28, 2022—Abbott announced the availability of its Amplatzer steerable delivery sheath in the United States. The device is used with the company’s Amplatzer Amulet left atrial appendage (LAA) occluder to treat patients with atrial fibrillation who are at risk of ischemic stroke. In August 2021, the company announced FDA approval of the Amplatzer Amulet device.

Abbott’s Amplatzer steerable delivery sheath is approved in Europe and Canada and has FDA clearance in the United States. The Amplatzer Amulet LAA occluder received CE Mark approval in 2013 and has been approved for use in more than 80 countries.

The first procedure with the Amplatzer delivery system in the United States was performed by Vivek Y. Reddy, MD, Director of Electrophysiology, Mount Sinai Hospital in New York, New York.

“Since its FDA clearance last year, doctors have been utilizing Abbott’s Amulet device to help patients reduce their risk of stroke from atrial fibrillation without the need for blood-thinning medication,” commented Dr. Reddy in Abbott’s press release. “With the Amplatzer steerable delivery sheath, United States physicians now have more flexibility and precise placement when implanting the Amulet device, in simple and complex anatomies. It allows doctors to close left atrial appendages in challenging cases, when otherwise it might not be possible.”