The next-generation WATCHMAN FLX device has been designed to minimise the risk of stroke in patients with non-valvular atrial fibrillation
CE mark approval for the next-generation WATCHMAN FLX device was secured in March last year. (Credit: Boston Scientific Corporation)
Boston Scientific has secured approval from the US Food and Drug Administration (FDA) for its WATCHMAN FLX left atrial appendage closure (LAAC) device.
The company has designed the next-generation WATCHMAN FLX device to minimise the risk of stroke in patients with non-valvular atrial fibrillation (NVAF) who require an alternative to oral anticoagulation therapy by permanently closing off the left atrial appendage.
The next-generation device is provided with a new fully rounded design to help physicians safely enter and maneuver within the left atrial appendage.
WATCHMAN FLX is available in broader size options to treat a range of patient anatomies
Boston Scientific’s WATCHMAN FLX is claimed to be the first LAAC device, which can be fully recaptured, repositioned and redeployed for accurate placement. Its new frame design facilitates optimal device engagement with the tissue for long-term stability and complete seal.
The company is offering the device in broader size options for the treatment of a wider range of patient anatomies.
The PINNACLE FLX study assessed the performance of the WATCHMAN FLX device as an alternative to long-term non-vitamin K antagonist oral anticoagulants (NOACs) and other OAC medications.
According to the company, the study achieved its primary safety and efficacy endpoints with data showing a low rate of major procedure-related safety events and high rate of effective LAAC.
The company will continue additional clinical research using the WATCHMAN FLX device for patients with NVAF through recruitment of patients in the OPTION trial to compare the device with oral anticoagulants in patients who also undergo a cardiac ablation procedure.
In addition, the device will be evaluated in the CHAMPION-AF trial with a broader OAC-eligible patient population in a head-to-head fashion against NOACs.
In March 2019, the company secured CE mark approval for the next-generation WATCHMAN FLX device.
Boston Scientific interventional cardiology president Joe Fitzgerald said: “We’ve been very pleased with the real-world clinical outcomes and positive physician feedback for the WATCHMAN FLX device in Europe and are excited to extend availability of this next-generation technology to patients and clinicians throughout the US.
“Our WATCHMAN technology was the first FDA-approved LAAC device on the market and has been implanted in more than 100,000 patients worldwide, and now with the WATCHMAN FLX device, we are taking the clinical benefits of the technology to the next level for more patients while further differentiating our structural heart portfolio in the U.S.”
In June, Boston Scientific has secured FDA 510(k) clearance for its LUX-Dx insertable cardiac monitor (ICM) system.