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Clinical evidence

Explore clinical evidence to learn why the WATCHMAN™  Implant has helped more than half a million patients leave oral anticoagulants behind.

The most studied LAAC device in the world

With over 20 years of LAAC innovation and experience, WATCHMAN has changed the lives of over 600,000 patients with proven, safe, and effective outcomes. The WATCHMAN Implant is the only device custom engineered for the LAAC procedure.

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Proven

99%

Patients successfully implanted (395/400)*1

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Safe

0.5%

Major adverse event rate†1

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Effective

100%

Effective LAA closure‡1

Proven patient outcomes

The WATCHMAN Implant is the most studied and implanted LAAC Device in the world.§ Hear from cardiologists as they discuss the efficacy and clinical outcomes of the WATCHMAN Implant and see why it’s the leader in LAAC therapy. 


 


 

Explore recent studies


CHAMPION-AF clinical trial: all endpoints met

CHAMPION-AF is the first and largest randomized controlled trial evaluating WATCHMAN as a first-line option vs. NOACs. Learn how these findings support WATCHMAN as an option for stroke risk reduction without the bleeding risk of long-term oral anticoagulants.2**

OPTION clinical trial: primary endpoints met

OPTION is the first randomized, head-to-head study comparing WATCHMAN FLX to OACs (95% DOACs) after cardiac ablation. Explore how WATCHMAN demonstrated non-inferior efficacy and superior safety.3

SURPASS Pro early outcomes: reaffirming proven performance

Early outcomes with the WATCHMAN FLX Pro Device from the SURPASS Pro NCDR LAAO Registry reaffirm the proven performance of WATCHMAN FLX.4


 

Learn about the first and largest trial evaluating WATCHMAN as a first-line option vs. NOACs


*Procedure success defined as successful delivery and release of a WATCHMAN FLX device into the LAA.

†Occurrence of one of the following events between the time of implant and within 7 days following the procedure or by hospital discharge, whichever  is later: all-cause death, ischemic stroke, systemic embolism, or device or procedure related events requiring open cardiac surgery or major endovascular intervention.

‡LAA closure at 12 months is defined as any peri-device flow with jet size ≤5mm per core laboratory-assessed TEE

§Represents all WATCHMAN models.

**WATCHMAN FLX is an FDA approved device being studied for an expanded indication as a first line therapy vs NOAC for NVAF patients. The use of WATCHMAN or WATCHMAN FLX as a first-line therapy for stroke risk reduction in NVAF patients is considered investigational.

Caution: Investigational Device. Limited by US law to investigational use only.

References

1. Kar, S., et al, Primary Outcome Evaluation of the Next Generation LAAC Device: Results from the PINNACLE FLX Trial, Circulation, 2021.

2. SK Doshi et al. Left Atrial Appendage Closure or Anticoagulation for Atrial Fibrillation. New England Journal of Medicine, March 202

3. 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.

4. Piccini J et al. Outcomes with WATCHMAN FLX Pro in Everyday Clinical Practice: Early Results from SURPASS Pro, HRS 2025.