Break the pattern of OACs

Long-term oral anticoagulant (OAC) therapy may be considered a standard of care for patients with non-valvular atrial fibrillation (AFib), but it comes with risks and consequences that can affect quality of life. These can include bleeding, fall and trauma risk in aging patients, non-adherence, stroke risks, drug interactions, lifestyle or diet restrictions, and medical and pharmacy costs.

The WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device offers a one-time, minimally invasive procedure for long-term stroke protection without the complications associated with OACs. With WATCHMAN, you have a modern, empowering alternative to break the pattern of reliance on OACs and lead the way in stroke protection for more patients.

Learn about WATCHMAN FLX Pro

Daily burdens of OACs are affecting patient quality of life

While OACs help protect against stroke, the reality for patients is that they experience daily burdens and risks, which can also lead to anxiety and fear.

BLEEDING RISK

People who take blood thinners for 10 years may be at ~9x higher risk of bleeding compared to a single year of DOAC therapy¹

ADHERENCE RISK

DOAC adherence below 80% increases stroke risk by 64%²

RISK OF STROKE

WATCHMAN FLX was as effective as OACs in stroke protection³

RISK OF COMPLICATIONS

AFib patients taking 5 or more medications* have a 33% higher chance of heart failure⁴

*55% of AFib patients are on 5 or more medications.

FALL RISK

>30% of individuals over age 65 fall every year^*5

*Falls are the most common type of accidents in people age 65 and older.

PATIENTS WANT ANOTHER OPTION

55% of AFib patients would rather not take blood thinners due to bleeding risk⁶

WATCHMAN LAAC Device: Peace of mind for patients with AFib

As the most studied LAAC device in the world, WATCHMAN LAAC Device has been proven to be an effective, one-time alternative so you can move more patients off OACs with procedural confidence and long-term safety. Protection against stroke risk. Protection against OAC risks and challenges. The WATCHMAN LAAC Device protects your AFib patients for life.

FDA-approved
Backed by robust clinical data
Eliminates the ongoing bleeding and adherence risks of OAC therapy
Provides comparable stroke protection with reduced bleeding risk

600,000+
Implanted in over 600,000 patients worldwide

WATCHMAN is indicated for a broad range of patient types

The WATCHMAN Implant may be an appropriate solution for your patients who meet these criteria:

Are at an increased risk for stroke based on CHA₂DS₂-VASc score and are recommended for anticoagulation therapy

Be suitable for short-term OAC therapy^†

Have a clinically supported need to seek a non-pharmacologic alternative to anticoagulation therapy^*

Note: Clinical trial results informed recent labeling updates.

†Updated specific post implant drug regimen options.
*Does not apply to patients who receive the WATCHMAN Implant concomitantly or sequentially with an AFib ablation; however, CMS coverage criteria (NCD 20.34) remain unchanged at this time. Commercial payer coverage policies vary.

The 2023 ACC/AHA/ACCP/HRS Guidelines for the Diagnosis and Management of Atrial Fibrillation consider left atrial appendage occlusion (LAAO) devices a 2a Class of Recommendation for patients with a contraindication to long-term OACs.

Consider WATCHMAN for patients who need stroke protection but have a documented bleed risk, fall risk, or challenges with long-term anticoagulation.^*

*Documentation supporting medical necessity is required for coverage.

History of bleed

Prior major or clinically relevant non-major bleeding while on OAC

Non-adherence to OAC therapy

Documented non-adherence or intolerance
Difficulty maintaining therapeutic anticoagulation
Cognitive, social, or lifestyle barriers to consistent OAC use

Increased risk of future bleed

High fall risk or frailty
Occupation, lifestyle, or activities associated with trauma or bleeding risk
Other medications that increase bleeding risk
Elevated bleeding risk based on HAS-BLED or other clinical factors

Increased risk of stroke

History of ischemic stroke or TIA related to:
- Non-adherence
- Sub-therapeutic anticoagulation
Ongoing stroke risk where durable protection is needed

Fall risk

Recurrent falls or balance impairment
Fall risk that makes long-term anticoagulation unsafe

Download indications guidelines

Robust clinical evidence

As the most studied, most implanted LAAC device in the world, WATCHMAN is a proven alternative to long-term OAC therapy for stroke risk reduction in patients with  non-valvular AFib.

See the clinical evidence

OPTION Clinical Trial

A breakthrough study in AFib treatment, and the first randomized, head-to-head study comparing WATCHMAN to OAC (95% DOACs) after cardiac ablation.

The primary endpoints showed WATCHMAN FLX was equally effective to anticoagulation, with a superior safety profile, which allowed patients to eliminate continuous medication use and significantly reduce bleeding risk while maintaining stroke protection.

1.6% all-stroke

1.2% ischemic stroke rate

WATCHMAN FLX demonstrated similar long-term efficacy outcomes compared  to OACs³

The trial met the primary efficacy endpoint of all-cause mortality, stroke or systemic embolism at 36 months, with the WATCHMAN FLX device demonstrating statistical non-inferiority to OAC (5.3% vs. 5.8%; P<0.0001)
The trial met the primary safety endpoint of non-procedural major bleeding or clinically relevant non-major bleeding at 36 months, with the WATCHMAN FLX device demonstrating statistical superiority to OAC (8.5% vs. 18.1%; P<0.0001)

50%

relative reduction in ISTH bleeding including procedural bleeding at 36 months⁷

Even with the inclusion of procedural bleeding, WATCHMAN FLX demonstrated a 50% relative reduction is ISTH major and clinically relevant non-major bleeding at 36 months: WATCHMAN: 9.5%; OAC: 18.1% (P<0.00001)

See study results

OPTION Clinical Trial discussion with Dr. Wazni

Hear Dr. Oussama Wazni (National Principal Investigator) discuss the OPTION Clinical Trial results.

Help your patients move beyond the burden of OACs

Many patients are being held back by the limitations and complications imposed on them by having to take OACs. Backed by unmatched experience and supported by clinical evidence, WATCHMAN takes stroke protection to a new level of care— so you can confidently move more patients off OACs, and they can go from daily pills to long-term protection.

Protect Your Patients

Hear cardiologists discuss WATCHMAN as a safe OAC alternative for stroke risk reduction.

Miguel’s story

Watch Miguel’s success story and hear from physicians who treated him.

Learn more about OAC risks and WATCHMAN

OAC Challenges flyer

Download

Clinical resources

Dig deeper into WATCHMAN

References

Granger CB, Alexander JH, McMurray JJV, et al.; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. New Eng J Med. 2011;365(11):981-992. doi:10.1056/NEJMoa1107039
Grymonprez M, Steurbaut S, Capiau A, et al. Minimal adherence threshold to non-vitamin k antagonist oral anticoagulants in patients with atrial fibrillation to reduce the risk of thromboembolism and death: a nationwide cohort study. Cardiovasc Drugs Ther. 2025;39(1):107-117. doi:10.1007/s10557-023-07507-3
Wazni O, et al. Randomized Comparison of Left Atrial Appendage Closure with Oral Anticoagulation After Catheter Ablation for Atrial Fibrillation. Late Breaking Clinical Trial, American Heart Association 2024.
https://www.ahajournals.org/doi/10.1161/JAHA.119.015089
https://www.ncbi.nlm.nih.gov/books/NBK560761/
Salmasi S., Loewen P.S., Tandun R., Andrade J.G., Vera M.A.D. Adherence to oral anticoagulants among patients with atrial fibrillation: a systematic review and meta-analysis of observational studies. BMJ Open. 2020;10 doi: 10.1136/bmjopen-2019-034778
Wazni OM, Saliba WI, Nair DG, et al. Left atrial appendage closure after ablation for atrial fibrillation. N Engl J Med. 2025;392(13):1277-1287. doi: 10.1056/NEJMoa2408308

WATCHMAN FLX Pro LAAC Device Indications, Safety and Warnings