Clinical evidence
500,000+
Lives changed and counting
Recent studies
OPTION
The OPTION clinical trial is the first randomized, head-to-head study comparing LAAC to OAC (95% DOACs) after cardiac ablation to determine if LAAC with the WATCHMAN FLX™ Device is a reasonable alternative in patients after AFib ablation.† 1
WATCHMAN FLX Pro pre-clinical data
The fluoropolymer-coated WATCHMAN FLX™ Pro device showed significantly less thrombus and reduced inflammation in a challenging canine model. Mechanistic studies demonstrated that the WATCHMAN FLX Pro device binds more albumin, leading to reduced platelet activation, less inflammation, and greater endothelial coverage (EC).2
SURPASS
The SURPASS 1 Year Outcomes analysis of the NCDR-LAAO Registry™ now includes the largest number of commercial WATCHMAN FLX™ Device patients to date. These data continue to support the best-in-class safety and long-term efficacy of the WATCHMAN FLX Device.3
Meta-Analysis
The Meta-Analysis is the largest comparison of peri-procedural success and short-term outcomes of WATCHMAN FLX vs Amplatzer Amulet reveals superior procedural safety, higher procedural success, and better LAA closure with WATCHMAN FLX.4
SEAL FLX
SEAL FLX is the first study to compare Amulet exclusively to WATCHMAN FLX and the results demonstrated that statistically superior complete occlusion* was achieved when using WATCHMAN FLX.5
PINNACLE FLX
The U.S. IDE Trial was designed to establish the procedural safety and left atrial appendage closure efficacy of WATCHMAN FLX™ LAAC device.6
Clinical trials
Active trials
CHAMPION‑AF
With over 500,000 patients implanted with the WATCHMAN platform, CHAMPION-AF extends Boston Scientific’s LAAC leadership by evaluating WATCHMAN FLX™ as a safe and effective first-line option versus NOAC to reduce stroke risk.
SIMPLAAFY clinical trial
SIMPLAAFY is a randomized controlled trial that will evaluate two monotherapy regimens vs. DAPT after implant with the WATCHMAN FLX™ Pro Device in patients with AF. SIMPLAAFY will assess whether a less intensive drug regimen may help mitigate post-implant bleeding risk and provide other viable options for post-implant treatment.
* 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)
†Thermal AFib ablation only
1. Wazni O, et al. Randomized Comparison of Left Atrial Appendage Closure with Oral Anticoagulation After Catheter Ablation for Atrial Fibrillation. Late Breaking Clinical Trial, American Heart Association 2024.
2. Saliba et al. Enhanced Thromboresistance and Endothelialization of a Novel Fluoropolymer-Coated Left Atrial Appendage Closure Device, JACC: Clinical Electrophysiology, 2023.
3. Kapadia SR et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry, Circulation: Cardiovascular Interventions, 2024.
4. Della Rocca et al, Procedural and Short-Term Follow-Up Outcomes of Amplatzer Amulet Occluder versus WATCHMAN FLX Device: A Meta-Analysis, Heart Rhythm 2022.
5. Korsholm-K et al. Left atrial appendage sealing performance of the Amplatzer Amulet and Watchman FLX device. J Interv Card Electrophysiol. 2022 Aug 11. doi: 10.1007/s10840-022-01336-4.
6. Kar S, et al. Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device: Results From the PINNACLE FLX Trial. Circulation. 2021;143:1754-1762.