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July 22, 2020

Boston Scientific’s device for reducing stroke risk gets FDA approval

The US Food and Drug Administration (FDA) has approved Boston Scientific's Watchman Flx Left Atrial Appendage Closure (LAAC) device to reduce the risk of stroke.

The US Food and Drug Administration (FDA) has approved Boston Scientific’s Watchman Flx Left Atrial Appendage Closure (LAAC) device to reduce the risk of stroke.

The device is indicated for patients with non-valvular atrial fibrillation (NVAF) who require an alternative to oral anticoagulation therapy for a permanent closure of the left atrial appendage.

It comes with a fully rounded design to enable safe entry and manoeuvre in the left atrial appendage.

Boston Scientific added that the product is the LAAC device designed for complete recapture, reposition and redeployment to allow an accurate placement.

The device’s new frame design facilitates optimal engagement with the tissue for long-term stability, as well as a quick and more complete seal.

In addition, it has broader size options compared to the previous generation device and is designed for the treatment of different patient anatomies.

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Boston Scientific global chief medical officer Dr Ian Meredith said: “Built upon the success of the Watchman platform and thousands of patient-years of clinical research, the next-generation Watchman Flx device is designed to offer increased ease of use for physicians and improved procedural outcomes for patients, including reduced complication risk and healing time.

“We have set the bar high and look forward to bringing these benefits to a wider range of US patients with NVAF who need an alternative to the bleeding risk and lifestyle challenges associated with long-term use of blood thinners.”

The new LAAC device was assessed in the pivotal PINNACLE FLX clinical study as an alternative to long-term non-vitamin K antagonist oral anticoagulants (NOACs) and other OAC therapies.

According to 12-month data, the study met the primary safety and efficacy endpoints with a low rate of major procedure-related safety events and highly effective LAAC rate. Results showed a 98.8% implant success rate.

The device is also being evaluated in the OPTION and CHAMPION-AF clinical trials.

Boston Scientific will immediately begin a limited launch of the device in the US. The device secured the European CE-Mark in March last year.

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