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WATCHMAN FLX™

Left Atrial Appendage Closure Device

WATCHMAN FLX™ Left Atrial Appendage Closure Device

WATCHMAN FLX is FDA APPROVED for use in nonvalvular atrial fibrillation patients who are eligible for anticoagulation therapy.
Built on the most studied and implanted LAAC device in the world, WATCHMAN FLX is designed to advance procedural performance and safety while expanding the treatable patient population.

Key Resources

Treating Physician Website Non-Implanting Physician Website Patient Website Download Center Indications, Safety, and Warnings
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PINNACLE FLX Clinical Study

The PINNACLE FLX US IDE Trial was designed to establish the Procedural Safety and LAA Closure Efficacy with the WATCHMAN FLX LAAC Device.

Study Design

  • 400 patient, 29 US site, single arm, non-randomized trial evaluating WATCHMAN FLX for non-inferiority to safety and efficacy performance goals based on the WATCHMAN™ device.
  • Follow-up: 45 days (+TEE), 6 months, 12 months (+TEE), 18 months, and 24 months
  • Patient Characteristics: Average CHA2DS2-VASc of 4.2±1.5, Average HAS-BLED of 2.0±1.0
  • Post Implant Drug Regimen: NOAC/ASA for 45 days, Clopidogrel/ASA to 6 months, ASA post 6 months
  • Primary Safety Endpoint: All-cause death, ischemic stroke, systemic embolism, or device- or procedure-related adverse events requiring surgery or major endovascular intervention within 7 days following the procedure or by hospital discharge, whichever is later.
  • Primary Efficacy Endpoint: The rate of effective LAA closure defined as any peri-device flow ≤5mm demonstrated by TEE at 12 months
  • Secondary Efficacy Endpoint: The occurrence of ischemic stroke or systemic embolism at 24 months from the time of enrollment
  • Inclusion/exclusion criteria is consistent with WATCHMAN clinical study inclusion/exclusion criteria. Patients must be eligible for short-term NOAC vs warfarin in previous clinical studies.


Primary Safety Endpoints1

All-cause death, ischemic stroke, systemic embolism, or device- or procedure-related adverse events requiring surgery or major endovascular intervention within 7 days following the procedure or by hospital discharge, whichever is later.
 
primary safety statistics
   
primary safety endpoint graph
* Based on the combined rate observed in PREVAIL(1) and CAP2(2), plus a clinically acceptable delta.
primary safety endpoint graph
1 Holmes, DR., et al, (2014). J AM Coll Cardiol 64(1): 1-12.
2 Holmes, DR., et al, JACC 2019.


Primary Efficacy Endpoints1

The rate of effective LAA closure defined as any peri-device flow ≤5mm demonstrated by TEE at 12 months.

 

primary efficacy endpoint graph
*LAA closure at 12 months is defined as any peri-device flow with jet size ≤5mm per core laboratory-assessed TEE
** Performance goal pased on the rates observed in PREVAIL(1) and CAP2(2), minus a clinically relevant delta

View Full 12-Month Data


Procedure Performance1

Procedure Performance and Sustained Success in Complex Anatomies Stats
* Implant success defined as successful delivery and release of a WATCHMAN FLX device into the LAA.


NOAC Discontinuation1

96.2% of patients discontinued NOAC at 45-day follow-up
Post-Implant Drug Regimen Options for WATCHMAN FLX
1 Holmes, DR., et al, (2014). J AM Coll Cardiol 64(1): 1-12.
2 Holmes, DR., et al, JACC 2019.


Designed to Treat Widest Range of Patient Anatomies

WATCHMAN FLX sizes range from (20mm - 35mm)

WATCHMAN FLX Device Sizes

 

 

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