Boston Scientific has received the US Food and Drug Administration (FDA) approval for the new-generation WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) device.
The device is indicated to reduce stroke risk in patients with non-valvular atrial fibrillation (NVAF) who need an alternative to oral anticoagulation therapy.
It is an updated version of the previous WATCHMAN FLX LAAC device, which was approved in the US in July 2020, and has been used in nearly 190,000 procedures worldwide.
The WATCHMAN FLX Pro is enhanced with a polymer coating designed to reduce device-related thrombus and enable rapid, controlled healing.
It comes with additional visualisation markers to enhance the device placement for optimal sealing around the LAA.
Also, the US biomedical engineering company offers the WATCHMAN FLX Pro device in a new 40mm size option, enabling physicians to treat a wide range of anatomies.
Boston Scientific cardiology 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 optimize treatment for their patients.”
According to the company, in the preclinical research, the new-gen device showed positive results for rapid, more controlled healing around the device surface.
Data showed that the polymer coating offered an 86% reduction in inflammation, a 70% reduction of thrombus and a 50% increase in endothelial tissue coverage.
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.
The device will be further assessed in the HEAL-LAA post-market study, which is expected to begin in a few weeks, based on outcomes from around 1,000 patients implanted at 60 sites in the US.
Boston Scientific senior vice president and global chief medical officer Kenneth Stein said: “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.
“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.”
