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Boston Scientific has received approval from the US Food and Drug Administration (FDA) for its WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) device.
The latest-generation device leverages the established safety and procedural performance of the WATCHMAN FLX LAAC device, which received approval in July 2020.
It features an advanced coating designed to lower device-related thrombosis while promoting rapid, controlled healing and endothelisation of the device surface.
The device also has visualisation markers, which help advance device placement for optimal sealing around the LAA.
The company offers a new 40mm size option for the device, helping physicians treat a wide range of anatomies with WATCHMAN technology.
Meanwhile, the new device is being assessed in the single-centre premarket WATCHMAN FLX Pro CT study.
The study utilises multiple imaging modalities for evaluating device tissue coverage after the procedure and its potential connection to clinical outcomes.
The device will undergo additional assessment in the post-market HEAL-LAA study, set to begin in the next few weeks.
This study will monitor the results of approximately 1,000 patients with NVAF who have received the technology at 60 different sites in the US.
Boston Scientific Cardiology group president Joe Fitzgerald said: “We are pleased to introduce US clinicians to our newest LAAC technology, which is designed to enhance post-procedural healing, improve the precision of WATCHMAN FLX Pro implants and expand the size range of treatable appendages.
“These enhancements to our WATCHMAN FLX technology will enable efficiency during implant procedures and allow physicians to optimise treatment for their patients.”
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- Source: https://www.medicaldevice-network.com/news/boston-scientific-laac-device-fda-approval/