Late-breaking data presented at European Society of Cardiology Congress and simultaneously published in Circulation support the recent approval for the Amplatzer Amulet granted by the FDA, Abbott said in a news release. The Amplatzer Amulet LAA occluder is comprised of a small pouch that connects to the upper left chamber of the heart in an effort to reduce ischemic stroke risk for people with atrial fibrillation (AFib).
Results presented show that the Amplatzer Amulet left atrial appendage (LAA) occluder was superior for the primary endpoint of LAA closure and non-inferior for the primary endpoints of safety and effectiveness when compared to Boston Scientific’s Watchman.
The Amplatzer Amulet LAA occluder is comprised of a small pouch that connects to the upper left chamber of the heart in an effort to reduce ischemic stroke risk for people with atrial fibrillation (AFib).
Data from the study included 98.4% successful implantations, compared to 96.4% success with the Watchman device. The primary endpoint of LAA closure was reached in 98.9% of patients for Amplatzer, compared to 96.8% in Watchman.
The Amplatzer Amulet platform proved non-inferior to Watchman for the co-primary safety endpoint (a composite of procedure-related complications, all-cause death or major bleeding through 12 months) and co-primary effectiveness endpoint (a composite of ischaemic stroke or systemic embolism through 18 months).
Additionally, Abbott noted that the Amplatzer Amulet did not require the use of blood thinners for participants following implant in the study, with 82% of Watchman patients discharged on anticoagulant therapy (warfarin plus aspirin). Only 20% of Amplatzer Amulet patients were discharged on anticoagulants, with most (75.7%) discharged on dual antiplatelet therapy (clopidogrel plus aspirin).
“Now backed by the strength of the Amulet IDE data and the ability to immediately close the LAA, our Amulet device has the potential to change the way physicians approach LAA occlusion therapy,” SVP of Abbott’s structural heart business Michael Dale said in the release. “Offering immediate, superior LAA closure allows Americans living with atrial fibrillation to experience greater peace of mind against the worry of having a stroke without the need for blood-thinning medication immediately following the procedure.”