1 Year Results
The SURPASS 1 Year Outcomes analysis of the NCDR-LAAO Registry™ now includes the largest number of commercial WATCHMAN FLX™ Device patients to date. These data continue to support the best-in-class safety of the WATCHMAN FLX Device 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
- The objective of this SURPASS analysis is to assess long term safety and efficacy outcomes at one 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.
- 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%
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)
SURPASS data reinforces the WATCHMAN FLX Device procedural success with 98% of patients implanted (N=66,894)1 across nearly all anatomies in a real-world setting, confirming the WATCHMAN FLX Device real world experience replicates clinical trial outcomes.
The 1-Year SURPASS Data confirms the excellent safety profile the WATCHMAN FLX Device demonstrated in the PINNACLE FLX trial, with the largest (N=66,894) WATCHMAN FLX Device patient population to date.
Comparison with PINNACLE FLX3
*45-Day Outcomes. Results from different studies are not directly comparable. For illustration purposes only.
The WATCHMAN FLX Device delivers proven stroke reduction in the largest and highest-risk patient population studied to date.
- Late Breaking Clinical Trial at CRT 2023, Presented by Samiar Kapdia.
- Kapadia, CRT 2022.
- Kar, Circulation 2021.
- Della Rocca et al. Heart Rhythm 2022.
- Ellis, Heart Rhythm, 2021.
- Korsholm, WM FLX First Experience, JACC, 2020.
- Bergmann, Alster Registry, Presented ePCR 2021.
- Betts, EHRA 2022.
- Galea, SWISS APERO Trial, Cirulation, 2021.
- Freeman, HRS 2022.