New Generation Devices for Left Atrial Appendage Closure
Key Summary
- Multiple next-generation left atrial appendage (LAA) closure devices are advancing through IDE, EFS, and first-in-human trials, targeting improved seal and reduced peridevice leak.
- The WATCHMAN Elite and Amulet 360 represent evolving plug devices, while novel systems explore plication, combined LAA closure with electrical isolation, and disruptive flow-based strategies.
- Early translational data, including pulsed field ablation-enabled devices and magnetogel technologies, suggest potential future shifts in AF stroke prevention strategies.
Introduction
At an afternoon session held on March 8 at Cardiovascular Research Technologies (CRT), Devi G. Nair, MD, FACC, FHRS, reviewed the rapidly evolving landscape of next-generation left atrial appendage (LAA) closure devices for stroke prevention in atrial fibrillation (AF). The session emphasized iterative improvements in plug and plication technologies, as well as emerging disruptive concepts designed to enhance seal, safety, and electrical isolation.
Session Highlights
Dr Nair divided device evolution into 4 categories: plug devices, plication devices, dual-function closure plus electrical isolation systems, and disruptive platforms.
Plug devices for LAAC
First among the plug devices, the WATCHMAN Elite (Boston Scientific)—next iteration after WATCHMAN FLX Pro—features optimized stent architecture, independent proximal and distal compression, enhanced sealing layers, a redesigned distal ball for safer implantation, and overall improved conformability, contract, and stability. A single-arm pivotal IDE trial is expected to begin in 2026, of which Dr Nair will be a national principal investigator.
The second plug device mentioned was the Amulet 360 (Abbott), the latest version in the Amulet and Amulet 2 line. Modifications of this design over its predecessors focus on improved conformability, anchoring, and sealing performance, and high implant success was demonstrated by the VERITAS study.1 Other plug devices included the Conformal, a foam-based device is that currently in a randomized controlled trial with more than 50% enrollment complete, and the Origin (Zenith) system (AuriGen Medical, Inc.), which introduces independent anchoring without exposed nitinol in the left atrium; the first-in-human (FIH) study of the Zenith is underway.
Alternative strategies for LAAC
Plication technologies include the Laminar (currently paused for redesign), and the endoluminal Append Transcatheter System and SEPIOLA (Endomatic, Inc.). The FIH study for the SEPIOLA has begun in Europe.
Hybrid devices capable of LAA closure and electrical isolation were highlighted as particularly relevant for electrophysiology as the field moves toward concomitant procedures. Dr Nair described a disc-and-lobe closure device, through which pulsed field energy can be delivered once deployed into the LAA. The FIH use was reported in 2023.2
Surgical innovation continues with the AtriClip FLEX Mini, designed to reduce atrial fabric exposure and featuring the smallest profile currently available for an LAA management device.3
Disruptive concepts include a pulmonary vein-to-left atrium shunt (ReLAAx Medical) to restore flow and reduce stasis (currently in bench testing), and magnetofluid-based magnetogel systems. In porcine models, magnetogels demonstrated smooth LAA filling without leak or adhesions.
Conclusions and Implications
Dr Nair emphasized that the primary goal across platforms remains prevention of peridevice leak. Improved conformability and sealing mechanisms are central to current IDE trials.
For clinicians managing AF, the expanding LAA device pipeline signals continued refinement in stroke prevention strategies. Ongoing trials will determine which platforms ultimately reshape clinical practice.
Devi G. Nair, MD, FACC, FHRS, is the Director of the Cardiac Electrophysiology & Research at St. Bernard’s Medical Center & Arrhythmia Research Group, Jonesboro, Arkansas.
References
- Nair D, Freixa X, Ellis CR, et al; VERITAS Investigators. Early outcomes with a next-generation dual-seal left atrial appendage occluder: results from the VERITAS study. JACC Clin Electrophysiol. 2026:S2405-500X(26)00028-9. doi:10.1016/j.jacep.2026.01.021
- Tang M, Wang X, Reddy VY. Simultaneous pulsed field ablation and mechanical closure of left atrial appendage using a novel device. JACC Case Rep. 2023;22:101963. doi:10.1016/j.jaccas.2023.101963
- AtriClip FLEX-Mini Device. AtriCure. 2026. Accessed March 11, 2026. https://www.atricure.com/healthcare-professionals/therapies/LAAM/atriclip-exclusion-system/atriclip-flex-mini-device
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