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.
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.
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