Late-breaking data presented at the European Society of Cardiology Congress and simultaneously published in Circulation support the FDA’s recent approval for the Amplatzer Amulet, Abbott said in a news release.
The Amplatzer Amulet Left Atrial Appendage (LAA) Occluder is a small pouch that connects to the upper left chamber of the heart to reduce ischemic stroke risk for people with atrial fibrillation (AFib).
The Abbott Park, Illinois-based medical device manufacturer said the results show its Amplatzer Amulet 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.
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.
Abbott also said the Amplatzer Amulet did not require blood thinners for participants following implant in the study, with 82% of Watchman patients discharged on anticoagulant therapy of warfarin plus aspirin. Only 20% of Amplatzer Amulet patients were discharged on anticoagulants, with 75.7% discharged on dual antiplatelet therapy of clopidogrel plus aspirin.
The trial pitted the Amplatzer Amulet head-to-head with the legacy Watchman 2.5 deice, which is no longer for sale in the U.S., according to Boston Scientific. The company said the next-generation Watchman FLX device however has registered strong clinical results, including 100% effective LAA closure and 99% procedural success, along with a 0.5% rate of major procedural complications.
“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,” said Michael Dale, the SVP of Abbott’s structural heart business, in the news 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.”