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.

* Based on the combined rate observed in PREVAIL(1) and CAP2(2), plus a clinically acceptable delta.

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.

*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