SURPASS Pro: reaffirming proven performance
Early outcomes with the WATCHMAN FLX Pro Device from the SURPASS Pro NCDR LAAO Registry reaffirm the proven performance of the WATCHMAN FLX platform by continuing to demonstrate a best-in-class safety profile and industry-leading seal along with high procedural success in routine clinical practice.1
Study design
- The objective of the analysis was to evaluate the safety and effectiveness of the WATCHMAN FLX Pro Device in routine clinical practice in a large, contemporary cohort in the United States using the National Cardiovascular Data Registry’s (NCDR) left atrial appendage occlusion (LAAO) Registry.
- Patients in the NCDR LAAO Registry who had an attempt for the WATCHMAN FLX Pro implant procedure between October 2023 and June 2024 (N=21,589) were included in this analysis
Key safety endpoint
The key safety end point was defined as the occurrence of all-cause death, ischemic stroke, systemic embolism, or device or procedure-related events requiring open cardiac surgery or major endovascular intervention between device implantation and 7 days or hospital discharge (whichever is later).
Key baseline patient demographics
- Age (y): 76.7 ± 7.7
- CHA2DS2-VASc: 4.6 ± 1.5
- HAS-BLED: 2.7 ± 1.1
- Female: 41.0%
- Prior stroke: 19.0%
- Clinically relevant bleeding: 43.6%
Indication for LAAO*
*Patient may have more than one indication for LAAO.
Proven safety outcomes
The WATCHMAN FLX Pro device continues to demonstrate the proven safety outcomes of the WATCHMAN FLX platform with a 0.20% key safety endpoint rate in a high-risk, all-comer patient population.
Clinical Outcomes at 45 Days
The safety and efficacy of the WATCHMAN FLX Pro device are sustained at 45 days with a 0.4% rate of pericardial effusion requiring intervention and 0.2% all stroke rate.
*Requiring intervention.
Consistent complete closure
WATCHMAN FLX Pro continues to deliver the industry-leading seal observed with the WATCHMAN FLX platform with 88% complete seal and 98% clinically relevant closure (=<3 mm) through 45 days.
Complete closure (0mm)
Clinically relevant closure (≤3mm)
Advancing outcomes and expanding the treatable population
Procedural performance
Procedural Success
SURPASS Pro reinforces previously observed success rates with 97% of patients successfully implanted (N=21,589) across nearly all anatomies in a real-world setting.
Broader range of anatomies†
More Patients Treated
3% of patients were implanted with the new 40 mm diameter WATCHMAN FLX Pro device.
Learn more about the WATCHMAN FLX™ Pro LAAC Device
References
1. Piccini J et al. Outcomes with WATCHMAN FLX Pro in Everyday Clinical Practice: Early Results from SURPASS Pro, HRS 2025.
† Measured maximum LAA ostium width and/or deployed closure device diameter must be ≥ 14.0 mm and ≤ 36.0 mm to accommodate available Closure Device sizes. LAA depth should be approximately half the labeled implant diameter or longer