WATCHMAN FLX device close up with decorative teal overlay

SURPASS Results

The SURPASS analysis of the NCDR-LAAO Registry™ includes the largest number of commercial WATCHMAN FLX patients to date. This data reinforces the outstanding safety of WATCHMAN FLX with 0.37% major procedural adverse event rate within 7 days or hospital discharge and 98% procedural success rate in > 16,000 real-world NVAF patients.1

Study Design

  • SURPASS assesses the safety and efficacy outcomes in patients in the NCDR-LAAO Registry that received a commercial WATCHMAN FLX device
  • This SURPASS analysis includes 16,048 patients receiving a WATCHMAN FLX device between August 5, 2020 and March 31, 2021
  • SURPASS will continue to assess WATCHMAN FLX patients included in the NCDR-LAAO Registry from August 2020 through August 2022 and will follow these patients through 2 years post-implant.

Mean baseline patient characteristics (N=16,048)

  • Average age/years: 76.1 ± 7.9
  • CHA2DS2-VASc: 4.8 ± 1.5
  • HAS-BLED: 2.4 ± 1.0
  • 40% women
  • 62% with prior clinically relevant bleeding event
Safety Endpoint

SURPASS demonstrated 0.37% major procedural adverse event rate within 7 days or hospital discharge in 16,048 commercial patients and confirmed the trusted safety profile of WATCHMAN FLX in real-world clinical practice setting.

37% icon and graph

SURPASS data reinforces WATCHMAN FLX procedural success with 98% of patients implanted (N=16,048/16,446)1 across nearly all anatomies in a real-world setting, confirming that WATCHMAN FLX real world experience replicates clinical trial outcomes. 

98% people icons

The SURPASS Data reinforces the excellent safety profile WATCHMAN FLX demonstrated in the PINNACLE FLX Trial, with the largest (n=16,048) real-world WATCHMAN FLX patients studied to date.

Comparison with PINNACLE FLX2

45-Day Outcomes
Comparison with PINNACLE FLX Chart

*Results from different clinical investigations are not directly comparable.

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