WATCHMAN FLXTM
Left Atrial Appendage Closure Device
Trusted Safety. Proven Efficacy. No Compromises.
Built on the most studied and implanted LAAC device in the world — WATCHMAN FLX™ is the leader in LAAC therapy. WATCHMAN FLX offers proven safety, unmatched procedural simplicity and excellent seal to help ensure optimal device performance.
Safety
WATCHMAN FLX sets the industry standard for low adverse event rates.
PINNACLE FLX1, 2
7-Day Major Adverse Events
Amulet IDE3,4
Procedure-Related Complications
SWISS-APERO5,6
Major Procedure-Related Complications
Simplicity
WATCHMAN FLX delivers unmatched procedural simplicity with near universal procedural success across a wide range of LAA anatomies.
Seal
WATCHMAN FLX demonstrated 90% complete closure* while Amulet demonstrated 63% complete closure in their respective IDE trials.
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.
Learn More About WATCHMAN FLX
Access Resources
Access WATCHMAN FLX resources by visiting our WATCHMAN Download Center
*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:
- 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.
- 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.
- 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.
- Procedural complications in the Amulet IDE is defined as adverse events which are adjudicated as procedure-related and require either an invasive surgical or percutaneous intervention.
- Galea. SWISS-APERO: A Randomized Trial of the Amulet Versus Watchman FLX Devices for Left Atrial Appendage Closure, TCT 2021.
- Major procedure-related complications for this trial were defined as as composite of death, cerebrovascular event, systemic embolism, major bleeding (BARC 3-5), clinically relevant pericardial effusion, device embolization, or acute kidney injury occurring within 7 days or thereafter if deemed procedure-related.
- Reddy VY, et al. JACC 2017; 70(24): 2964-2975.