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July 20, 2020

FDA Approves Boston Scientific’s Next-Generation Watchman FLX Left Atrial Appendage Closure Device

July 21, 2020—Boston Scientific Corporation announced it has received FDA approval for the Watchman FLX, the company’s next-generation left atrial appendage (LAA) closure device. A limited launch of the device in the United States will commence immediately.

According to Boston Scientific, the Watchman FLX is indicated to reduce the risk of stroke in patients with nonvalvular atrial fibrillation (NVAF) who need an alternative to oral anticoagulation therapy by permanently closing off the LAA.

In March 2019, the company announced CE Mark approval for the next-generation Watchman FLX device.

Boston Scientific stated that the Watchman FLX features a new, fully rounded design that offers physicians the ability to safely enter and maneuver within the LAA. The device can be fully recaptured, repositioned, and redeployed for precise placement, and the new frame design allows for optimal device engagement with the tissue for long-term stability and a faster, more complete seal. Also, the Watchman FLX device is available in broader size options than the previous-generation device and can treat a wider range of patient anatomies.

In May 2020, the company announced that 12-month results from the pivotal PINNACLE FLX study were presented as a late-breaking clinical trial at HRS 2020 Science, the annual Heart Rhythm Society Scientific Sessions held as a virtual event. PINNACLE FLX evaluated the performance of the Watchman FLX device as an alternative to long-term nonvitamin K antagonist oral anticoagulants and other oral anticoagulant medications.

The study met its primary safety and efficacy endpoints, with data demonstrating a low rate of major procedure-related safety events (0.5% at 7 days postprocedure) and a high rate of effective LAA closure (100% with peridevice flow ≤ 5 mm at 12 months postprocedure). 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, which will compare the device to oral anticoagulants in patients who also undergo a cardiac ablation procedure. Additionally, the CHAMPION-AF trial will study a broader oral anticoagulant-eligible patient population in a head-to-head fashion to compare the device against nonvitamin K antagonist oral anticoagulants, advised Boston Scientific.

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