FDA Approves WATCHMAN FLX for Stroke Reduction by LAA Occlusion

July 22, 2020

The US Food and Drug Administration (FDA) has approved Boston Scientific's WATCHMAN FLX transcatheter left atrial appendage (LAA) occluder device as an alternative to oral anticoagulation (OAC) therapy in patients with nonvalvular atrial fibrillation (AF), the company has announced.

As with its predecessor WATCHMAN device, which the agency approved in 2015, the device is intended to permanently close off the LAA from the rest of the left atrial chamber, thereby cutting the chance that potentially embolic and stroke-inducing thrombi will form.

The new WATCHMAN incarnation "features a new, fully rounded design that offers physicians the ability to safely enter, and maneuver within, the left atrial appendage," said Boston Scientific in a press release.

"It is the first LAAC device that 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," it said.

"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 WATCHMAN FLX demonstrated its effectiveness for the job, with the FDA watching, in a recent 12-month analysis of data from the PINNACLE FLX study, the company said. Among upcoming trials of the device in a variety of settings, it noted, is the Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation (OPTION).

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