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WATCHMAN

Our focus

Providing a lifetime of stroke risk reduction and freedom from blood thinners for people with atrial fibrillation (AFib) not caused by a heart valve problem.

Patients share their journey with WATCHMAN

Delivering meaningful innovation

Leading the way in left atrial appendage closure (LAAC)

For more than 20 years, the WATCHMAN therapy has led the advancement of LAAC with clinical evidence and device innovation. During this time, we’ve partnered with physicians from around the globe to help more than 500,000 people living with AFib reduce their stroke risk and leave blood thinners behind.

Proven in performance, optimized for healing

Built on the proven safety profile of the WATCHMAN FLX™ Left Atrial Appendage Closure Implant, the WATCHMAN FLX™ Pro LAAC Implant is designed to enhance the healing process and optimize therapy success for more patients. 

The device is placed in the left atrial appendage (LAA) of the heart during a safe, minimally invasive, one-time procedure. It permanently seals off the LAA, where stroke-causing clots commonly form in people with AFib, which reduces their risk of stroke and need for lifelong blood thinners.

Precision for every anatomy

The WATCHMAN TruSteer Access System increases procedural success and accuracy, improving outcomes for all patients and anatomy types. Used to deliver the WATCHMAN FLX Pro Implant into the LAA, the WATCHMAN TruSteer access system guides intuitive adjustments during deployment, helping achieve optimal device placement in the most complex anatomies. 

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With 20 years of clinical trial and real-world experience - including 15+ clinical trials – The WATCHMAN Implant has a proven safety record.

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The WATCHMAN Implant has a high implant success rate of 99% and a low major complication rate** of 0.5%.2

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In a clinical trial, 96% of people were able to stop taking blood thinners 45 days after getting a WATCHMAN FLX Implant.¹


Conditions we treat

  • Stroke risk reduction for people with atrial fibrillation not caused by a heart valve problem

59M

patients with atrial fibrillation globally.2

10.5M

patients with atrial fibrillation in the U.S.3

5x

higher stroke risk in people with AFib vs. those with a regular heartbeat.4

+90%

of stroke-causing clots that come from the heart are formed in the LAA.5


Solutions we offer

  • Left Atrial Appendage Closure with the WATCHMAN FLX™ Pro Left Atrial Appendage Closure Implant

Product spotlights

Sources

  1. Kar, S., et al, Primary Outcome Evaluation of the Next Generation LAAC Device: Results from the PINNACLE FLX Trial, Circulation, 2021.
  2. Linz, Dominik, et al. Atrial fibrillation: epidemiology, screening and digital health. Lancet Reg Health Eur. 2024 Feb 1:37:100786
  3. Noubiap JJ, Tang JJ, Teraoka JT, Dewland TA, Marcus GM. Minimum National Prevalence of Diagnosed Atrial Fibrillation Inferred From California Acute Care Facilities. J Am Coll Cardiol. 2024 Oct 15;84(16):1501-1508. doi: 10.1016/j.jacc.2024.07.014. Epub 2024 Sep 11. PMID: 39269390.
  4. FAQ About AFib. American Heart Association, Inc., 2023. Available at: www.heart.org/-/media/Files/Health-Topics/Atrial-Fibrillation/FAQ-About-AFib.pdf. Accessed June 10, 2024.
  5. Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996;61:755-759.
  6. Saliba et al. JACC: Clinical Electrophysiology, May 2023. Bench testing or pre-clinical study results may not necessarily be indicative of clinical performance. N=12 in a pre-clinical canine study.
  7. *Procedure success defined as successful delivery and release of a WATCHMAN FLX device into the LAA.

** In a post FDA approval analysis. Major complication is defined as an occurrence of one of the following events between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device or procedure related events requiring open cardiac surgery or major endovascular intervention.

WATCHMAN FLX Pro Brief Summary

WATCHMAN TruSteer Access System Brief Summary