Key Features

• Next-Generation Design: Features an enhanced frame and delivery system for precise placement and optimal seal.
• Flexibility and Conformability: Adapts to a wide range of LAA anatomies for secure closure and reduced risk of leakage.
• Procedural Simplicity: Streamlined delivery system with fewer steps, enhancing procedural efficiency and patient comfort.

Technical Specifications

• Device Composition: Nitinol frame with permeable polyester fabric to promote tissue ingrowth and secure closure over time.
• Size Options: Available in various sizes to accommodate different LAA anatomies and patient needs.
• Safety Features: Designed with robust safety features to minimize procedural risks and ensure patient well-being.

Clinical Benefits
The Watchman FLX LAAC System offers compelling clinical benefits:

• Stroke Risk Reduction: Significantly reduces the risk of stroke in NVAF patients compared to long-term anticoagulation therapy.
• Quality of Life Improvement: Allows patients to discontinue or reduce dependence on blood thinners, improving quality of life.
• Proven Efficacy: Supported by extensive clinical data demonstrating high closure rates and low complication rates.

PINNACLE FLX Clinical Study
The PINNACLE FLX US IDE Trial was designed to establish the Procedural Safety and LAA Closure Efficacy with the WATCHMAN FLX LAAC Device.

Study Design

• 400 patient, 29 US site, single arm, non-randomized trial evaluating WATCHMAN FLX for non-inferiority to safety and efficacy performance goals based on the WATCHMAN™ device.
• Follow-up: 45 days (+TEE), 6 months, 12 months (+TEE), 18 months, and 24 months
• Patient Characteristics: Average CHA2DS2-VASc of 4.2±1.5, Average HAS-BLED of 2.0±1.0
• Post Implant Drug Regimen: NOAC/ASA for 45 days, Clopidogrel/ASA to 6 months, ASA post 6 months
• Primary Safety Endpoint: All-cause death, ischemic stroke, systemic embolism, or device- or procedure-related adverse events requiring surgery or major endovascular intervention within 7 days following the procedure or by hospital discharge, whichever is later.
• Primary Efficacy Endpoint: The rate of effective LAA closure defined as any peri-device flow ≤5mm demonstrated by TEE at 12 months
• Secondary Efficacy Endpoint: The occurrence of ischemic stroke or systemic embolism at 24 months from the time of enrollment
• Inclusion/exclusion criteria is consistent with WATCHMAN clinical study inclusion/exclusion criteria. Patients must be eligible for short-term NOAC vs warfarin in previous clinical studies.