SURPASS 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

Study design

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.

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%

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.

Procedural success

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.