WATCHMAN FLX device on white background

UPDATE:
FDA Approves Use of DAPT or OAC Immediately Following Implant with WATCHMAN FLXTM Device

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Trusted Safety. Proven Efficacy. No Compromises.

Built on the most studied and implanted LAAC device in the world — the WATCHMAN FLX™ device is the leader in LAAC therapy. The WATCHMAN FLX device offers proven safety, unmatched procedural simplicity and excellent seal to help ensure optimal device performance.

Safety

The WATCHMAN FLX device sets the industry standard for low adverse event rates.

PINNACLE FLX1, 2

7-Day Major Adverse Events

SURPASS3

Major Procedural Adverse Events

Meta-Analysis4

7-Day Major Adverse Events

Simplicity

WATCHMAN FLX delivers unmatched procedural simplicity with near universal procedural success across a wide range of LAA anatomies.

Seal

The WATCHMAN FLX device demonstrated 90% complete closure* while Amulet™ demonstrated 63% complete closure in their respective IDE trials.

Proven Outcomes: PINNACLE FLX Pivotal Trial Results

See Clinical Evidence

  

The Leader In LAAC Therapy

  

WATCHMAN FXD Curve™ Access System

The WATCHMAN FXD Curve™ Access System is designed for the WATCHMAN FLX™ LAAC device, bringing smoother deployment and successful placement to the delivery of the most studied and implanted LAAC device in the world.

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Access Resources

Access WATCHMAN FLX device resources by visiting our WATCHMAN Download Center

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*Complete LAA occlusion defined as no visible peri-device leak (PDL) and absence of contrast patency in the distal LAA (LAA/left atrium Hounsfield ratio <0.25).

Sources:

  1. Kar S, et al. Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device: Results From the PINNACLE FLX Trial. Circulation. 2021;143:1754-1762.
  2. Procedural safety events in the PINNACLE FLX trial is defined as the occurrence of one of the following events between the time of implant and within 7 days after the procedure or by hospital discharge, whichever was later: death, ischemic stroke, systemic embolism, or device or procedure-related events requiring open cardiac surgery or major endovascular intervention.
  3. Kapadia, SURPASS Registry, CRT 2022
  4. Della Rocca et al, Procedural and Short-Term Follow-Up Outcomes of Amplatzer Amulet Occluder versus WATCHMAN FLX Device: A Meta-Analysis, Heart Rhythm 2022.
  5. Reddy VY, et al. JACC 2017; 70(24): 2964-2975.
  6. Lakkireddy, Primary Outcomes of the Amplatzer™ Amulet™ IDE Randomized Controlled Trial, Presented as an abstract at the European Society of Cardiology Congress, August 30, 2021.