Clinically Proven Results
The WATCHMAN Implant is a one-time, minimally invasive procedure designed to reduce the risk of strokes that originate in the left atrial appendage (LAA). With over 90,000 patients implanted globally, 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 is the Only FDA-Approved Device Proven to Reduce Stroke Risk in Patients with Non-Valvular Atrial Fibrillation (NVAF)
Five-year meta-analysis of Protect AF and Prevail data showed comparable primary efficacy results to wafarin1
- Long-term results from a patient-level meta-analysis of the PROTECT AF (2,717 pt yrs) and PREVAIL (1,626 pt yrs) trials demonstrated that WATCHMAN offered1:
- Comparable primary efficacy and all-cause stroke reduction
- Statistically significant reductions in disabling and fatal stroke (largely driven by reduction in hemorrhagic stroke), as well as mortality
- Notably, WATCHMAN has now demonstrated ischemic stroke reduction similar to that observed with warfarin in both the PROTECT AF and PREVAIL trials, as well as four additional registries, when accounting for differences in CHA2DS2-VASc score
- Reddy VY, Doshi SK, Kar S, et al. 5-year outcomes after left atrial appendage closure. J Am Coll Cardiol. 2017;70(24):2964-2975.
- Price MJ, Reddy VY, Valderrábano M, et al. Bleeding outcomes after left atrial appendage closure compared with long-term warfarin: a pooled, patient-level analysis of the WATCHMAN randomized trial experience. JACC Cardiovasc Interv. 2015;8(15):1925-1932.
- Holmes DR Jr, Kar S, Price MJ, et al. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014;64(1):1-12.
- Friberg. Eur Heart J (2012);
- Reddy VY, et al. JACC 2017; 70(24): 2964-2975.
- NICE UK (2014).
- Phillips K, et al. ILC Heart & Vasculature 2019; 23(100358).
- Boersma LVA, et al. Circ Arrhy Electrophysiol. 2019; 12e006841.
- Sharma D, et al. JACC 2016; 67(18): 2190-2192.
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.
The WATCHMAN Access System is intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Do not use the WATCHMAN Device if:
- Intracardiac thrombus is visualized by echocardiographic imaging.
- 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 46 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 fluoro and ultrasound guidance (TEE recommended) in multiple angles (e.g., 0°, 45°, 90°, 135°).
- Do not release the WATCHMAN Device from the core wire if the device does not meet all release criteria (see step 14).
- 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-ALIGN1 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 a left atrial appendage closure device or implantation procedure include but are not limited to:Air embolism, Airway trauma, Allergic reaction to contrast media/medications or device materials, Altered mental status, Anemia requiring transfusion, Anesthesia risks, Angina, Anoxic encephalopathy, Arrhythmias, Atrial septal defect, AV fistula, Bruising, hematoma or seroma, Cardiac perforation, Chest pain/discomfort, Confusion post procedure, Congestive heart failure, Contrast related nephropathy, Cranial bleed, Decreased hemoglobin, Deep vein thrombosis, Death, Device embolism, Device fracture, Device thrombosis, Edema, Excessive bleeding, Fever, 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, Myocardia 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 – Ischemic, Stroke – Hemorrhagic, Systemic embolism, TEE complications (throat pain, bleeding, esophageal trauma), Thrombocytopenia, Thrombosis, Transient ischemic attack (TIA), Valvular damage, Vasovagal reactions. There may be other potential adverse events that are unforeseen at this time.
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.
- Eikelboom JW, Connolly SJ, Brueckmann M, et al. N Engl J Med 2013;369:1206-14.