About the WATCHMAN Implant

The WATCHMAN Implant is a minimally invasive, one-time procedure designed to reduce the risk of stroke in your AFib patients for life, without the need for lifelong OACs.

How WATCHMAN works

In non-valvular atrial fibrillation (AFib) patients, over 90% of stroke-causing clots that come from the left atrium are formed in the left atrial appendage (LAA).1 While long-term oral anticoagulant (OAC) therapy has been the standard of care for reducing stroke risk for AFib patients, it can cause persistent and significant challenges that can evolve over time.

The WATCHMAN™ Implant is designed to reduce the risk of strokes that originate in the LAA without the bleed risks associated with long-term OACs.

Watch the video to see how the WATCHMAN FLX Pro Implant procedure works.

WATCHMAN FLX Pro Implant design

Built on the proven performance of WATCHMAN FLX, WATCHMAN FLX Pro includes features designed to promote faster healing.2

WATCHMAN FLX Pro device
New 40mm device

to treat the widest range of anatomies

 
WATCHMAN FLX Pro Implant
HEMOCOAT™ Technology

a hemocompatible coating to promote faster, more complete endothelialization*

WATCHMAN FLX Pro Implant
WATCHMAN FLX™ Platform

with proven safety & procedural performance

WATCHMAN FLX Pro Implant
Three new radiopaque markers help

position and anchor device with a new level of visual accuracy

*Enhanced healing demonstrated in pre-clinical model with no anticoagulation

Post-implant drug regimen options

WATCHMAN FLX Pro offers post-implant drug regimen options for both standalone and post-AF ablation procedures. This provides the flexibility to select the ideal drug regimen that is best for individual patients, with clinical outcomes that support safety and efficacy in preventing stroke.

Learn more about post-implant drug regimen options

Concomitant AFib ablation and WATCHMAN Implant procedures

For AFib patients suitable for the WATCHMAN LAAC Device, implanting physicians may suggest one of three procedure options, depending on their eligibility for an AFib ablation and the physician’s discretion.

Standalone

A WATCHMAN device is implanted in a single procedure.

Concomitant

An AFib ablation is performed, and a WATCHMAN device is implanted within a single procedural setting.

Sequential

An AFib ablation is performed, and a WATCHMAN device is implanted in a later procedure.**

Note: The FARAPULSE PFA Catheter is pictured as representative example for AFib ablation, though any modality may be used
Performing an AFib ablation and implanting a WATCHMAN LAAC Device in a single procedural setting offers a comprehensive solution to address AFib progression, rhythm control and stroke risk reduction. This approach may allow patients to avoid multiple AFib-related procedures and enhance their overall satisfaction.

**In the OPTION trial, sequential LAAC was a minimum of 90 days (as a protocol-driven blanking period) and less than 6 months post-AF ablation.

References

  1. Blackshear JL., Odell JA. Annals of Thoracic Surg. 1996; 61: 755-759.
  2. Saliba, W. et al. JACC EP, 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.
WATCHMAN FLX Pro Device Brief Summary

SH-2333212-AA