WATCHMAN - 100k Patients Implanted and Counting

WATCHMAN Changes the Game

For non-valvular Afib patients who need an alternative to oral anticoagulants, the WATCHMAN Implant is a one-time minimally invasive procedure that may provide a lifetime of stroke-risk reduction without the bleeding risk associated with long-term OAC therapy.

With almost 20 years of clinical-trial and real-world experience—including over 10 clinical trials—WATCHMAN is the most studied left atrial appendage closure (LAAC) device.

WATCHMAN FLX Now FDA Approved

 

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WATCHMAN device

Why WATCHMAN

OACs Come With Challenges

Atrial fibrillation (AF) affects about 6 million people in the US—a number that is expected to double by 2030.1 Oral anticoagulants (OACs) are an important therapy, but they come with risk factors and limitations, and many patients need an alternative:

Warfarin

  • Bleeding Risk
  • Daily Regimen
  • High Non-Adherence Rates
  • Regular INR Monitoring
  • Food and Drug Interaction Issues 
  • Complicates Surgical Procedures

Oral Anticoagulants

  • Bleeding Risk
  • Daily or 2x/Daily Regimen
  • High Non-Adherence Rates
  • Complicates Surgical Procedures
  • High Cost

NVAF Patients Are Looking for an Alternative

alternative icon Over a third of people with AF (38%) feel trapped between the fear of having a stroke and fear of the risks associated with OACs. In fact, more than 4 in 5 people with AF taking an OAC (83%) say they would be willing to try a different treatment to help reduce their risk of stroke.3

Clinically Proven Results

proven results icon Long-term results from PROTECT AF and PREVAIL demonstrated WATCHMAN reduced risk of disabling stroke, bleeding post procedure, and mortality vs. warfarin.

Established Safety

safety icon WATCHMAN has a high 95% procedural success rate4* with a low 1.5% major complication rate, even in the highest risk patients studied to date.3

Suitable for a Broad Range of Patients

patients icon WATCHMAN may be suitable for a broad range of patients with non-valvular atrial fibrillation, including those who have had a bleeding event on an OAC, a lifestyle or occupation that puts them at an increased risk of bleeding, difficulty maintaining INR or a drug medication regimen not compatible with OAC therapy.

Affordable Alternative

lower cost icon WATCHMAN is less expensive than warfarin by year 2 and half the cost by year 5.5
WATCHMAN FLX device

*Procedural success defined as deployment and release of the device into the left atrial appendage (LAA) with no leak greater than 5 mm.

References:

  1. Benjamin EJ, Muntner P, Alonso A, et al. Heart disease and stroke statistics—2019 update: a report from the American Heart Association. Circulation. 2019;137:e1-e473.
  2. WatchUsNow.com. The Harris Poll online survey. Boston Scientific. SH-574213-AA. https://www.watchusnow.com/?page=d75be9d4-ba36-456c-a72d-dc3df07892da. Accessed March 28, 2019. 
  3. Ellenbogen KA, et al. Heart Rhythm. 2019; 16(5): S310.
  4. Reddy VY, et al. JACC 2017; 69(3): 253-261.
  5. Armstrong S, et al. ISPOR 2015.

 

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.​

INDICATIONS FOR USE​

The WATCHMAN Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who:​

  • Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy;​
  • Are deemed by their physicians to be suitable for anticoagulation therapy; and​
  • Have an appropriate rationale to seek a non-pharmacologic alternative to anticoagulation therapy, taking into account the safety and effectiveness of the device compared to anticoagulation therapy.

CONTRAINDICATIONS

Do not use the WATCHMAN® Device if:​

  • Intracardiac thrombus is present.​
  • An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is​ present.​
  • The LAA anatomy will not accommodate a device. See Table 45 (in the IFU).​
  • The patient has a known hypersensitivity to any portion of the device material or the individual components (see Device Description section in the IFU) such that the use of the WATCHMAN device is contraindicated.​
  • Any of the customary contraindications for other percutaneous catheterization procedures (e.g., patient size too small to accommodate TEE probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present.​
  • There are contraindications to the use of anticoagulation therapy, aspirin, or P2Y12 inhibitor. ​

WARNINGS

Implantation of the WATCHMAN Device should only be performed by interventional cardiologists and/or electrophysiologists who are trained in percutaneous and transseptal procedures and who have completed the WATCHMAN Physician Training program.​

  • This device has not been studied in pregnant or breastfeeding women. Careful consideration should be given to use of the Closure Device in pregnant and/or breastfeeding women due to the risk of significant exposure to x-rays and the use of anticoagulation medicine.​
  • Device selection should be based on accurate LAA measurements obtained using echocardiographic imaging guidance (TEE recommended in multiple angles [e.g., 0º, 45º, 90º, 135º]) to avoid improper Closure Device sizing.​
  • Do not release (i.e., unscrew) the WATCHMAN Device from the core wire unless all release criteria are satisfied to avoid suboptimal results.​
  • Potential for Closure Device embolization exists with cardioversion <30 days following Closure Device​ implantation; verify Closure Device position post-cardioversion during this period.​
  • Appropriate post-procedure drug therapy should be followed. See Post-Procedure Information section​ (in the IFU) for further detail. ​

PRECAUTIONS

  • The safety and effectiveness (and benefit-risk profile) of the WATCHMAN Device has not been established in patients for whom long-term anticoagulation is determined to be contraindicated.​
  • The LAA is a thin-walled structure. Use caution when accessing the LAA and deploying the Closure​ Device
  • Use caution when introducing a WATCHMAN Access System to prevent damage to cardiac structures.​
  • Use caution when introducing the Delivery System to prevent damage to cardiac structures.​
  • To prevent damage to the Delivery Catheter or Closure Device, do not allow the WATCHMAN Device to protrude beyond the distal tip of the Delivery Catheter when inserting the Delivery System into the Access Sheath.​
  • If using a power injector, the maximum pressure should not exceed 100 psi.​

PATIENT SELECTION FOR TREATMENT

In considering the use of the WATCHMAN FLX Device, the rationale for seeking an alternative to long-term anticoagulation therapy and the safety and effectiveness of the device compared to anticoagulation should be taken into account.​

  • The presence of indication(s) for long-term anticoagulation therapy, other than non-valvular atrial​ fibrillation (e.g. mechanical heart valve, hypercoagulable states, recurrent deep venous thrombosis).

Details regarding the indications, contraindications, warnings, and precautions for oral anticoagulants approved for patients with non-valvular atrial fibrillation are provided in their respective Instructions for Use. Of note:​

  • The safety and effectiveness (and benefit-risk profile) of the WATCHMAN FLX Device has not been established in patients for whom long-term anticoagulation is determined to be contraindicated.​
    Factors that need to be considered for the WATCHMAN FLX Device and implantation procedure include​ the following:​
    • Overall medical status, including conditions which might preclude the safety of a percutaneous, transcatheter procedure.​
    • Suitability for percutaneous, transseptal procedures, including considerations of:​
      • Cardiac anatomy relating to the LAA size and shape.​
      • Vascular access anatomy (e.g., femoral vein size, thrombus, or tortuosity).​
      • Ability of the patient to tolerate general or local anesthesia.​
      • Ability of the patient to undergo required imaging.​
    • Ability to comply with the recommended post-WATCHMAN FLX Device implant pharmacologic regimen (see Post-Procedure Information section in the eIFU) especially for patients at high risk for bleeding.​

ADVERSE EVENTS

Potential adverse events (in alphabetical order) which may be associated with the use of a left atrial appendage closure device or implantation procedure include but are not limited to:​
Air embolism, Airway trauma, Allergic reaction to contrast media, anesthetic, WATCHMAN Implant material, or medications, Altered mental status, Anemia requiring transfusion, Anesthesia risks, Angina, Anoxic encephalopathy, Arrhythmias, Atrial septal defect, Bruising, hematoma or seroma near the catheter insertion site, Cardiac perforation, Chest pain/discomfort, Confusion post procedure, Congestive heart failure, Contrast related nephropathy, Cranial bleed, Death, Decreased hemoglobin, Deep vein thrombosis, Device embolism, Device fracture, Device thrombosis, Edema, Embolism, Excessive bleeding, Fever, Fistula, Groin pain, Groin puncture bleed, Hematuria, Hemoptysis, Hypotension, Hypoxia, Improper wound healing, Inability to reposition, recapture, or retrieve the device, Infection/pneumonia, Interatrial septum thrombus, Intratracheal bleeding, Major bleeding requiring transfusion, Misplacement of the device/improper seal of the appendage/movement of device from appendage wall, Myocardial erosion, Nausea, Oral bleeding, Pericardial effusion/tamponade, Pleural effusion, Prolonged bleeding from a laceration, Pseudoaneurysm, Pulmonary edema, Renal failure, Respiratory insufficiency/failure, Stroke – Hemorrhagic, Stroke – Ischemic, Surgical removal of the device, TEE complications (e.g., throat pain, bleeding, esophageal trauma), Thrombocytopenia, Thrombosis, Transient ischemic attack (TIA), Valvular or vascular damage, Vasovagal reactions​

There may be other potential adverse events that are unforeseen at this time.​

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