Next-Generation WATCHMAN FLX LAAC Device Gains FDA Approval
Boston Scientific has announced that U.S. Food and Drug Administration (FDA) approval has been given to its next-generation left atrial appendage closure (LAAC) device. The device is indicated for patients with nonvalvular atrial fibrillation (NVAF) to reduce their risk of stroke and require an alternative to oral anticoagulation (OAC) therapy.
Evidence from the pivotal PINNACLE FLX study provided support for the FDA approval. Presented as a late-breaking clinical trial during the Heart Rhythm Society 2020 Science virtual meeting, the study met its primary safety and efficacy endpoints at 12 months, with data demonstrating a low rate of major procedure-related safety events (0.5% at seven days post procedure) and a high rate of effective LAAC (100% with peri-device flow < 5 mm at 12 months post procedure). Data also demonstrated a high implant success rate of 98.8%.
Additional clinical research using the WATCHMAN FLX device for patients with NVAF will continue via enrollment in the OPTION trial – comparing the device to OAC in patients who also undergo a cardiac ablation procedure – as well as in the CHAMPION-AF trial, which will study a broader OAC-eligible patient population in a head-to-head fashion to compare the device against NOACs.
The company states the new technology is built on the WATCHMAN, the most studied and implanted LAAC device worldwide. Features of the new FLX LAAC include a new, fully rounded design that offers physicians the ability to safely enter, and maneuver within, the left atrial appendage. It is the first LAAC device that can be fully recaptured, repositioned and redeployed for precise placement. The new frame design allows for optimal device engagement with the tissue for long-term stability and a faster, more complete seal. The WATCHMAN FLX device is available in broader size options than the previous generation device and can treat a wider range of patient anatomies.
The company announced CE Mark for the next-generation WATCHMAN FLX device in March 2019 and will immediately commence a limited launch of the device in the U.S.
Keywords: Atrial Fibrillation, Administration, Oral, Atrial Appendage, United States Food and Drug Administration, Anticoagulants, Catheter Ablation, Stroke, Cytarabine
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