The results of the study exclusively comparing the next-generation Watchman FLX left atrial appendage closure (LAAC) and Amplatzer Amulet devices were presented at the Cardiovascular Research Foundation’s 2021 TCT meeting, according to the study’s abstract.
Findings from the SEAL FLX single-center, retrospective study of 300 Danish patients found that Watchman FLX demonstrated superiority in the area of LAA closure and peri-device leak.
Watchman FLX showed significantly better complete LAA occlusion at eight weeks compared to the Amplatzer Amulet (72.6% vs. 30.5% as evaluated by cardiac CT), according to the study. Peri-deice leak areas were significantly smaller with the Watchman FLX device as well (32 mm2 at the lobe of the WATCHMAN FLX device vs. 90 mm2 at the lobe and 93 mm2 at the disc of the Amulet device).
According to Abbott, when closure at the level of the disc and lobe are combined, the study found that Amulet achieved 90% closure compared to 84% for Watchman FLX.
“Complete occlusion was achieved in a significantly higher proportion of patients treated with the Watchman FLX compared to the Amulet device” lead investigator Dr. Kasper Korsholm (Dept. of Cardiology, Aarhus University Hospital, Denmark) concluded in the study’s abstract. “In addition, PDL appeared significantly smaller with the FLX than the Amulet. Conceptual device design differences make interpretation of results complex, and randomized head-to-head studies with clinical outcomes are needed”
Earlier this year, Abbott claimed victory in a head-to-head trial of the Amplatzer Amulet and the legacy Watchman 2.5 device, no longer for sale in the U.S. That trial data served to support the FDA’s approval of the Amplatzer Amulet.
