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THE WATCHMAN IMPLANT IS THE ONLY FDA-APPROVED DEVICE PROVEN TO SAFELY AND EFFECTIVELY REDUCE STROKE RISK IN PATIENTS WITH NVAF


  • The FDA approval of the WATCHMAN Implant is based on long-term data from numerous clinical trials involving more than 2400 patients and nearly 6000 patient-years of follow-up 
  • The WATCHMAN clinical program resulting in FDA approval consisted of multiple studies:
    • An initial pilot study; two randomized clinical trials: PROTECT AF and PREVAIL; and CAP and CAP 2 registries 

PROTECT AF 5-YEAR PRIMARY EFFICACY RESULTS


  • At 4 years of follow-up in the PROTECT AF trial, the WATCHMAN Implant significantly reduced all-cause mortality risk vs warfarin1
  • WATCHMAN demonstrated comparable stroke risk reduction, and statistically superior reductions in hemorrhagic stroke and cardiovascular death compared to warfarin over long-term follow-up in the PROTECT AF study1

WATCHMAN DEMONSTRATED COMPARABLE EFFICACY VS WARFARIN: META-ANALYSIS


  • A meta-analysis of the PROTECT AF (n=732) and PREVAIL (n=382) trials documented2:
    • Comparable primary efficacy results in patients who received a WATCHMAN Implant vs patients in the warfarin arm
    • A significant reduction in hemorrhagic stroke risk that was superior to long-term warfarin
    • Significant improvement in CV mortality and major bleeding >7 days post-procedure compared with warfarin   

Adapted from Holmes 2015. Copyright © 2015, JACC Online by American College of Cardiology Foundation.

WATCHMAN EXIBITED A FAVORABLE EFFECT ON LONG-TERM BLEEDING


  • The patient-level meta-analysis of the PROTECT AF and PREVAIL trials demonstrated that the longer a patient has a WATCHMAN Implant, the greater the reduction in bleeding events3
  • At 6 months post-procedure, WATCHMAN reduced major bleeding events vs warfarin by 72% (1.0 vs 3.5; P<0.001)3

*Major bleeding defined as adverse event that was assigned one of several bleeding codes and was adjudicated by an independent Clinical Events Committee as significant (life-threatening or resulting in hospitalization, prolongation of hospitalization, substantial disability, or death).

The study followed patients for 5 years.

 

 

Download the WATCHMAN Referring Physician Brochure to learn about the WATCHMAN solution

This informative guide provides an overview of the benefits of the WATCHMAN Implant and helps referring physicians select appropriate patients for the procedure. 

PROVEN SAFETY


Review implant success rates and other safety data from the clinical studies and initial US commercial experience with WATCHMAN.

 

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