SEAL FLX Study Results
SEAL FLX is the first study that compares complete occlusion results of the WATCHMAN FLXTM device and the AmplatzerTM AmuletTM device exclusively, using cardiac computed tomography (CT)1.
- Single-center, retrospective study of LAAO implantation at Aarhus
University Hospital (Denmark) between 2018-2020.
1st cohort: Amplatzer Amulet (n=150) 2018 – 2019
2nd cohort: WATCHMAN FLX (n=150) 2019 – 2020
- Cardiac CT was performed 8 weeks after LAAO
WATCHMAN FLX Demonstrated Statistically Superior Complete Occlusion* vs Amulet (p=0.001)
Complete Occlusion* at 8 Weeks (per CT)
Complete Occlusion* on CT Imaging1
More Leak Pathways with a Two-Component Device at 8 Weeks (per CT)
Leak Measurements were Statistically Significantly Larger with Amulet than WATCHMAN FLX (p=0.008) at 8 Weeks (per CT)
Leak Size (mm2)
WATCHMAN FLX’s One-Component Design Translates to Clear Sealing Advantages
Single Landing Zone and Overlapping Treatment Ranges
Complicated, Mis-Matched Measurements
Precision Placement Control
Trade-off Between Disc and Lobe Placement
1. Korsholm-K et al.; TCT 2021.
2. Lakkireddy, Amulet Tips and Tricks in Simple and Complex Anatomy, TVT 2018.
3. Saw, Cardiac CT angiography for device surveillance after endovascular left atrial appendage closure, European Heart Journal - Cardiovascular Imaging, Volume 16, Issue 11, November 2015, Pages 1198–1206, https://doi.org/10.1093/ehjci/jev067
* Complete LAA occlusion defined as no visible peri-device leak (PDL) and absence of contrast patency in the distal LAA (LAA/left atrium Hounsfield ratio <0.25)