The Leader in LAAC Therapy: The only LAAC device built on 20 years of design innovation


Proven. Safe. Effective.

The world's most studied & implanted LAAC implant

Evolved from 20 years of WATCHMAN innovation and the experience gained from 400,000+ successful implants and 10+ clinical trials1, the WATCHMAN FLX™ Implant is the LAAC technology with proven safety and trusted patient outcomes.


Advanced safety

Clinically proven safe outcomes

Clinically proven safe outcome statistics

The low 0.5% event rate demonstrates the enhanced safety profile of the WATCHMAN FLX LAAC device, showing a statistically significant difference to the performance goal set for similar safety endpoints in the PREVAIL Trial and CAP2 Registry.1

Major adverse event rate statistics

* 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

Advanced procedural performance

Proven efficacy outcomes

The WATCHMAN FLX Device is designed for enhanced LAA closure which was demonstrated with 100% rate of effective LAA closure at 12 months.1

LAA closure at 12 months*1

LAA closure graph

NOAC discontinuation

of patients discontinued OAC after 45 days‡1

* LAA closure at 12 months is defined as any peri-device flow with jet size ≤5mm per core laboratory-assessed TEE
† Performance goal based on the rates observed in PREVAIL(2) and CAP2(3), minus a clinically relevant delta
‡ Procedure success defined as successful delivery and release of a WATCHMAN FLX device into the LAA


Broad range of anatomies

Designed to treat the widest ranges of patient anatomies with greater device sizing overlap and less appendage depth needed for deployment.

99% Patients Successfully Implanted (395/400)

6.6% of enrolled patients in PINNACLE FLX were previous WATCHMAN screen fails or case aborts, and 97% of those patients were successfully implanted with WATCHMAN FLX4

* Procedure success defined as successful delivery and release of a WATCHMAN FLX device into the LAA
† Measured maximum LAA ostium width and/or deployed closure device diameter must be ≥ 14.0 mm and ≤ 31.5 mm to accommodate available Closure Device 
sizes. LAA depth should be approximately half the labeled implant diameter or longer
‡ This figure includes both the main cohort, and roll-in patients (totaling 452 implants)


2 year outcomes demonstrate long term safety & efficacy

Clinical outcomes between 12 and 24 months5

  • Low rates of major bleeding (all BARC-3)​​
  • No additional DRT, systemic embolisms or pericardial effusions beyond those reported at 1 year
  • ​​No device embolization with WATCHMAN FLX through 2 years
safety and efficacy graph

PINNACLE FLX pivotal trial results

The PINNACLE FLX US IDE clinical study was designed to establish the procedural safety and closure efficacy of next generation LAAC device, WATCHMAN FLX

See full study design
teal background with close up of WATCHMAN FLX device

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  1. Kar, S., et al, Primary Outcome Evaluation of the Next Generation LAAC Device: Results from the PINNACLE FLX Trial, Circulation, 2021.
  2. Holmes, DR., et al, (2014). J AM Coll Cardiol 64(1): 1-12.
  3. Holmes, DR., et al, JACC 2019.4. Ellis et al. Presented at AF Symposium 2020.
  4. Ellis et al. Presented at AF Symposium 2020.
  5. Kar S., 24-Month Outcomes of PINNACLE FLX Study with the WATCHMAN FLX™ Left Atrial Appendage Closure Device Presented as Late-Breaking Clinical Science, Presented at TVT July 21, 2021.