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.
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:
- Bleeding Risk
- Daily Regimen
- High Non-Adherence Rates
- Regular INR Monitoring
- Food and Drug Interaction Issues
- Complicates Surgical Procedures
- Bleeding Risk
- Daily or 2x/Daily Regimen
- High Non-Adherence Rates
- Complicates Surgical Procedures
- High Cost
NVAF Patients Are Looking for an Alternative
|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
|Long-term results from PROTECT AF and PREVAIL demonstrated WATCHMAN reduced risk of disabling stroke, bleeding post procedure, and mortality vs. warfarin.|
Suitable for a Broad Range of Patients
|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.|
*Procedural success defined as deployment and release of the device into the left atrial appendage (LAA) with no leak greater than 5 mm.
- 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.
- 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.
- Ellenbogen KA, et al. Heart Rhythm. 2019; 16(5): S310.
- Reddy VY, et al. JACC 2017; 69(3): 253-261.
- 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 “Directions 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 warfarin; and
- Have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.
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 47 (in the DFU). 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 warfarin, aspirin, or clopidogrel. The patient has a known hypersensitivity to any portion of the device material or the individual components (see Device Description section) such that the use of the WATCHMAN device is contraindicated.
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). Do not release the WATCHMAN Device from the core wire if the device does not meet all release criteria.If thrombus is observed on the device, warfarin therapy is recommended until resolution of thrombus is demonstrated by TEE. The potential for device embolization exists with cardioversion <30 days following device implantation. Verify device position post-cardioversion during this period. Administer appropriate endocarditis prophylaxis for 6 months following device implantation. The decision to continue endocarditis prophylaxis beyond 6 months is at physician discretion. For single use only. Do not reuse, reprocess or resterilize.
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 device. Use caution when introducing the 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 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. In view of the concerns that were raised by the RE-ALIGN study of dabigatran in the presence of prosthetic mechanical heart valves, caution should be used when prescribing oral anticoagulants other than warfarin in patients treated with the WATCHMAN Device. The WATCHMAN Device has only been evaluated with the use of warfarin post-device implantation.
Potential adverse events (in alphabetical order) which may be associated with the use of the WATCHMAN Implant 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 risk, 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, Surgical removal of the device, Stroke – Hemorrhagic, Stroke – Ischemic, Systemic embolism, TEE complications (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.
Eikelboom JW, Connolly SJ, Brueckmann M, et al. N Engl J Med 2013;369:1206-14.