Proven. Safe. Effective.
The world's most studied & implanted LAAC implant
Evolved from 20 years of WATCHMAN innovation and the experience gained from 300,000+ successful implants and 10+ clinical trials1, the WATCHMAN FLX™ Implant is the LAAC technology with proven safety and trusted patient outcomes.
Clinically proven safe outcomes
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
* 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
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.
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)
- Kar, S., et al, Primary Outcome Evaluation of the Next Generation LAAC Device: Results from the PINNACLE FLX Trial, Circulation, 2021.
- Holmes, DR., et al, (2014). J AM Coll Cardiol 64(1): 1-12.
- Holmes, DR., et al, JACC 2019.4. Ellis et al. Presented at AF Symposium 2020.
- Ellis et al. Presented at AF Symposium 2020.
- 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.