Abbott’s Amplatzer Amulet LAA Occluder Device Approved by FDA

August 16, 2021—Abbott announced FDA approval of the company’s Amplatzer Amulet left atrial appendage (LAA) occluder for the treatment of patients with atrial fibrillation who are at risk of ischemic stroke. The device offers immediate closure of the LAA, reducing the risk of stroke and immediately eliminating the need for blood-thinning medication.

According to Abbott, the Amulet device features dual-seal technology to completely and immediately seal the LAA. The device can treat a broad range of anatomies with a wide range of occluder sizes. Additionally, it is recapturable and repositionable to ensure optimal placement.

The company advised that FDA approval was supported by findings from the Amplatzer Amulet investigational device exemption (IDE) trial. The large-scale randomized head-to-head study compared Amulet with an alternative minimally invasive LAA occlusion device. Data from the trial will be presented virtually at ESC 2021, the European Society of Cardiology’s annual congress on August 30, 2021.

Dhanunjaya Lakkireddy, MD, of the Kansas City Heart Rhythm Institute at HCA Midwest Health in Overland Park, Kansas, served as Principal Investigator for the Amulet IDE trial.

“As the world’s population continues to age, we’re seeing a surge in atrial fibrillation cases, and with that comes increased risk of stroke,” commented Dr. Lakkireddy in the company’s announcement. “The approval of Abbott’s Amulet device provides physicians with a treatment option that reduces the risk of stroke and eliminates the need for blood-thinning medication immediately after the procedure, which is incredibly valuable given the bleeding risks associated with these medicines.”

The Amplatzer Amulet LAA occluder received its initial European CE Mark approval in 2013. It has been approved for use in more than 80 countries, including those in Europe, as well as Canada and Australia, stated Abbott.