WATCHMAN FLX device close up with decorative teal overlay

Clinical Evidence in LAAC

Proven Safety: From Clinical IDE Trial to Real-World Outcomes

The WATCHMAN FLX™ Left Atrial Appendage Closure Device advances safety with a high procedural success rate and low major complication rate. This evidence was first identified in the PINNACLE FLX IDE Trial and validated in recent real-world studies like the SURPASS Analysis of 16,048 WATCHMAN FLX Implant patients.1,2

SURPASS Real-world Outcomes Reinforce PINNACLE FLX Trial Outcomes

45-Day Outcomes

*Results from different clinical investigations are not directly comparable.

Enhanced Safety

Major Adverse Event Rates

WATCHMAN FLX Implant delivers safety like no other with low major adverse event rates across multiple studies.

Major adverse event rates chart closeup.
Implant success rates chart closeup.

Procedural Success

Implant Success Rates

From the original PINNACLE FLX IDE clinical trial to the recent real-world SURPASS analysis, procedural success for the WATCHMAN FLX Implant remains excellent.

Trusted Outcomes

Ischemic Stroke Rates

Multiple studies confirm the trusted patient outcomes of the WATCHMAN FLX Implant in both clinical trial and real-world practice settings.

Ischemic stroke rates chart closeup.

Clinical Resources

PINNACLE FLX IDE Clinical Summary

Key clinical findings from PINNACLE FLX: The US IDE Trial Designed to Evaluate the Procedural Safety and Closure Efficacy with the WATCHMAN FLX Device.

SURPASS Analysis Clinical Summary

Key clinical findings from the SURPASS analysis of the NCDR-LAAO Registry™ which includes the largest number of commercial WATCHMAN FLX patients to date (n=16,048).

WATCHMAN FLX: Trusted Safety. Proven Efficacy. No Compromises.

1.Late Breaking Clinical Trial at CRT 2022, Presented by Dr. Samir Kapadia
2.Kar. S, Circulation, 2021