Watchman FLX Pro gains US FDA approval

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Watchman FLX Pro

Boston Scientific has received US Food and Drug Administration (FDA) approval for the latest-generation Watchman FLX Pro left atrial appendage closure (LAAC) device.

The device, which is indicated to reduce stroke risk in patients with non-valvular atrial fibrillation (NVAF) who need an alternative to oral anticoagulation therapy, now features a polymer coating, visualisation markers and a broader size matrix to treat a wider range of patients.

The Watchman FLX Pro is the latest generation of the Watchman FLX LAAC device, which was approved in July 2020 and has been used in nearly 190,000 of the more than 300,000 procedures completed to date globally.

“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,” said Joe Fitzgerald, group president, Cardiology, Boston Scientific. “These enhancements to our Watchman FLX technology will enable efficiency during implant procedures and allow physicians to optimize treatment for their patients.”

“There is a rich history of safe use and low thrombosis rates in cardiovascular devices that utilise this thromboresistant polymer coating, and we have adapted that model to provide a more streamlined healing process that begins immediately following LAAC,” said Kenneth Stein, senior vice president and global chief medical officer, Boston Scientific. “We believe this evolution of the Watchman device also gives promise for a future with less thrombosis risk, which may eventually enable a simpler post-implant drug regimen for patients.”

The Watchman FLX Pro device is currently being studied in the WATCHMAN FLX Pro CT study, a single-centre premarket study using multiple imaging modalities to assess post-procedural device tissue coverage and the relationship, if any, to clinical outcomes. It will also be further evaluated in the post-market HEAL-LAA study, which will commence over the coming weeks and follow outcomes from approximately 1,000 patients with NVAF implanted with the technology at 60 sites in the USA.


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