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WATCHMAN Proven to Reduce Stroke Risk

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 >8000 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 

LONG-TERM RESULTS DEMONSTRATED WATCHMAN REDUCED RISK OF STROKE, BLEEDING AND MORTALITY


  • Long-term results from a patient-level meta-analysis of the PROTECT AF (2,717 pt yrs) and PREVAIL (1,626 pt yrs) trials demonstrated that WATCHMAN offered1:
    • Comparable primary efficacy and all-cause stroke reduction
    • Statistically significant reductions in disabling and fatal stroke (largely driven by reduction in hemorrhagic stroke), as well as mortality
    • Notably, WATCHMAN has now demonstrated ischemic stroke reduction similar to that observed with warfarin in both the PROTECT AF and PREVAIL trials, as well as four additional registries, when accounting for differences in CHA2DS2-VASc score   

PROTECT AF and PREVAIL Long-Term Results Data Chart

WATCHMAN EXHIBITED A FAVORABLE EFFECT ON LONG-TERM BLEEDING


  • A landmark bleeding analysis of the PROTECT AF and PREVAIL trials demonstrated that the longer a patient has a WATCHMAN Implant, the greater the reduction in bleeding events2
  • At 6 months post-procedure, WATCHMAN reduced major bleeding events vs warfarin by 72% (1.0 vs 3.5; P<0.001)2

*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.

References:
1. Reddy VY, Doshi SK, Kar S, et al. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J. Am Coll Cardiol. 2017; In Press.
2. Price MJ, Reddy VY, Valderrábano M, et al. Bleeding outcomes after left atrial appendage closure compared with long-term warfarin: a pooled, patient-level analysis of the WATCHMAN randomized trial experience. JACC Cardiovasc Interv. 2015;8(15):1925-1932.

 

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