WATCHMAN FLX device close up with decorative teal overlay

1 Year Results

Download the Clinical Summary

The SURPASS 1 Year Outcomes analysis of the NCDR-LAAO Registry™ now includes the largest number of commercial WATCHMAN FLX™ Implant patients to date. These data continue to support the best-in-class safety of the WATCHMAN FLX Implant with a 0.49% major procedural adverse event rate within 7 days or hospital discharge (whichever is later) and 98% implant success in >66,000 real-world NVAF patients.1

Study Design

  • The objective of this SURPASS analysis is to assess long term safety and efficacy outcomes at 1 year with WATCHMAN FLX in a routine, real-world setting.​
  • This analysis includes the largest commercial WATCHMAN FLX patient population to date, with 66,894 patients implanted between August 5, 2020 and March 31, 2022. ​

Patient Characteristics:

  • Age: 76.2 ±7.9 Years​
  • CHA2DS2-VASc Score: 4.8±1.5
  • ​HAS-BLED Score: 2.4±1.0​
  • Women: 41%​
  • Clinically Relevant Bleeding: 57.7%
Safety Endpoint

The 0.49% major procedural adverse event rate within 7 days or hospital discharge demonstrated in the SURPASS 1 Year Outcomes analysis further supports the unmatched safety profile observed in separate controlled and real-world analyses.​

Key Safety Endpoints​

(within 7 days or discharge)

37% icon and graph

SURPASS data reinforces the WATCHMAN FLX Implant procedural success with 98% of patients implanted (N=66,894)1 across nearly all anatomies in a real-world setting, confirming the WATCHMAN FLX Implant real-world experience replicates clinical trial outcomes. ​

Procedural success

Procedural Success graph

The 1-Year SURPASS Data confirms the excellent safety profile the WATCHMAN FLX Implant demonstrated in the PINNACLE FLX trial, with the largest (N=66,894) WATCHMAN FLX Implant patient population to date.​.

WATCHMAN FLX device with decorative teal overlay

Comparison with PINNACLE FLX3

45-day outcomes

Comparison with PINNACLE FLX Chart

*45-Day Outcomes. Results from different studies are not directly comparable. For illustration purposes only.

The WATCHMAN FLX Implant delivers proven stroke reduction in the largest and highest-risk patient population studied to date.​

stroke statistics and orange brain icon
WATCHMAN FLX device with decorative teal overlay
  1. Late Breaking Clinical Trial at CRT 2023, Presented by Samiar Kapdia.​
  2. Kapadia, CRT 2022. 
  3. ​Kar, Circulation 2021. ​
  4. Della Rocca et al. Heart Rhythm 2022.
  5. ​Ellis, Heart Rhythm, 2021. ​
  6. Korsholm, WM FLX First Experience, JACC, 2020.​
  7. Bergmann, Alster Registry, Presented ePCR 2021. ​
  8. Betts, EHRA 2022. ​
  9. Galea, SWISS APERO Trial, Cirulation, 2021. ​
  10. Freeman, HRS 2022​​.