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Close up view of the WATCHMAN implant on a blue background

SURPASS early results

Real-world experience with the WATCHMAN FLX Implant: SURPASS early results
 

The SURPASS early results analysis

The SURPASS early results analysis of the NCDR-LAAO Registry™ reinforces the outstanding safety of WATCHMAN FLX with a 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

Composite of all-cause death, ischemic stroke, systemic embolism, or device/procedure-related events requiring open cardiac surgery or major endovascular intervention between device implantation and seven days or hospital discharge, (whichever is later).

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.

0.37%

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%

The early results SURPASS Data reinforces the excellent safety profile WATCHMAN FLX demonstrated in the PINNACLE FLX trial, with over 16,000 real-world WATCHMAN FLX patients analyzed.

Comparison with PINNACLE FLX2

45-day outcomes

Comparison with PINNACLE FLX Chart.
*Results from different clinical investigations are not directly comparable.

The SURPASS 1 Year Outcomes analysis of the NCDR-LAAO Registry™ now includes the largest number of commercial WATCHMAN FLX™ Implant patients to date.

Next: SURPASS 1-year results

References 

1. Late Breaking Clinical Trial at CRT 2022, Presented by Dr. Samir Kapadia.​ 

2. Kar, Circulation 2021. ​