*Caution: The Amulet™ 360 Left Atrial Appendage Occluder* is an INVESTIGATIONAL DEVICE. LIMITED BY LAW TO INVESTIGATIONAL USE ONLY. This product is not available for sale in any geography.
Impact of procedural experience of a next generation LAAO device - insights from the VERITAS Study1
Outcomes and procedure metrics measured in three case experience groups
458 procedures
53 physicians
High implant success for all case experience levels
p=0.019
90% single device use in procedures by experienced implanters
100%
Peri-device leak ≤3 mm regardless of experience
96.1%
Complete closure (0mm leak) in experienced group
0% in ranges 3–5mm and >5 mm
Procedure time, sheath use time, and fluoro time decreased with increasing experience
Key Takeaways
- 100% implant success after implanter's 5th case
- Complete closure (0mm leak) observed in majority of cases, from roll-ins (84.3%) to experienced (96.1%)
- Procedural time significantly decreased with implanter experience
Previously presented data at AF Symposium 2026
First results from the VERITAS Study were presented at AF Symposium 2026, providing the earliest clinical evidence evaluating the Amulet™ 360 LAAO* in patients with nonvalvular AF. The findings show that both primary endpoints were met with statistically significant performance, supported by independent core lab review.
Study Outcomes
Early findings from the VERITAS Study were presented at the 2026 AF Symposium in Boston, providing the first data on the safety, effectiveness, and early closure performance for the Amulet™ 360 LAAO*.
0%
p < 0.0001
Primary Safety Endpoint**
(performance goal: 3.75%)
100%
p < 0.0001
Primary Effectiveness***
Endpoint (performance goal: 96.6%)
Independent core lab observed
100%
clinically relevant closure (no PDL >3mm identified)
93.3%
complete closure (0mm leak) on 45-day follow up TEE
Initial procedural metrics
99.8%
implant success
88%
of subjects implanted with a single device attempt
0.5%
pericardial effusion requiring drainage
0%
device embolization
*Previously reported data.
** Primary safety endpoint was key adverse events (death, ischemic stroke, systemic embolism, or device/procedure related complications requiring open cardiac surgery or major endovascular Intervention) through 7 days post-procedure or hospital discharge, whichever was later.
***Primary effectiveness endpoint: LAA occlusion defined as no peri-device flow or peri-device flow ≤ 5 mm based on Doppler color flow TEE at the 45-day follow-up visit as assessed by an independent core laboratory.
1. Nair D, Lakkireddy, D, Alkhouli, M, et al. Impact of Procedural Experience of a Next Generation Left Atrial Appendage Occlusion Device – Insights from the VERITAS Study. Presented by Dr. Devi Nair at NY Valves; June 26, 2026; New York, NY USA.
*Caution: The Amulet™ 360 Left Atrial Appendage Occluder* is an INVESTIGATIONAL DEVICE. LIMITED BY LAW TO INVESTIGATIONAL USE ONLY. This product is not available for sale in any geography.
MAT-2623073 v2.0