Abbott’s Amplatzer Amulet LAA Occluder Late-Breaking Data Presented at ESC Congress

August 30, 2021—Abbott announced late-breaking data from the Amulet investigational device exemption (IDE) trial of the company’s Amplatzer Amulet left atrial appendage (LAA) occluder device for the treatment of patients with atrial fibrillation (AFib) at an increased risk of stroke. The trial results supported FDA approval of Amulet in the United States, which the company announced on August 16.

According to the company, the large-scale, multicenter, head-to-head study compared the Amulet LAA occluder with the Watchman device (Boston Scientific Corporation) trial and found that how the Amulet device was superior for the primary endpoint of LAA closure and noninferior for the primary endpoints of safety and effectiveness versus the comparator device.

The findings were presented in a late-breaking Hot Line session at the European Society of Cardiology’s ESC Congress 2021 held virtually August 27-30.

The findings included the following:

• Amulet was successfully implanted in 98.4% of patients compared to 96.4% of patients receiving the Watchman device
• Amulet demonstrated superiority for the primary endpoint of LAA closure compared to Watchman (98.9% vs 96.8%; P-superiority = .0025)
• Amulet demonstrated noninferiority to the comparator Watchman device for the coprimary safety endpoint (a composite of procedure-related complications, all-cause death, or major bleeding through 12 months) and the coprimary effectiveness endpoint (a composite of ischemic stroke or systemic embolism through 18 months)
• Amulet did not require the use of blood thinners for patients after implantation in the study; whereas 82% of Watchman patients were discharged on anticoagulant therapy (warfarin plus aspirin), only 20% of Amulet patients were discharged on anticoagulants—75.7% were discharged on dual antiplatelet therapy (clopidogrel plus aspirin).

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.

“Atrial fibrillation cases have increased in recent years as the world continues to age, making stroke risk more prevalent and resulting in higher usage of blood-thinning medication that can lead to bleeding and other complications,” commented Dr. Lakkireddy in Abbott’s press release. “Amulet demonstrated a clear benefit for people suffering from atrial fibrillation who are at risk of stroke and in need of LAA occlusion. The Amulet IDE trial data show that we can effectively treat these patients with Amulet and get them off blood thinners immediately following implantation.”

Abbott’s Amulet device features the company’s Dual-Seal technology with a lobe to fill the body of the LAA and a disc to close off the opening into the LAA. It provides immediate closure of the LAA, reducing the risk of stroke and immediately eliminates the need for blood-thinning medication following implant. The Amulet occluder is available in a wide range of sizes to treat a broad range of patients and allows recapturing and repositioning to ensure optimal placement, stated the company.