Sam Brusco, Associate Editor09.06.23
Boston Scientific has gained U.S. Food and Drug Administration (FDA) approval for its latest-generation WATCHMAN FLX Pro left atrial appendage closure (LAAC) device.
The technology aims to reduce stroke risk in patients with non-valvular atrial fibrillation (NVAF) needing an alternative to oral anticoagulation therapy. The device now tous a polymer coating, visualization markers, and a broader size matrix.
The WATCHMAN FLX LAAC device was approved in July 2020 and used in almost 190,000 of the over 300,000 WATCHMAN procedures successfully completed to date globally, according to Boston Scientific.
WATCHMAN FLX Pro has a coating engineered to reduce device-related thrombus and enable faster, controlled healing and endothelization of the device surface. Further, new visualization markers aim to enhance device placement for optimal sealing around the LAA. The device is also available in a new 40mm size option.
"We are pleased to introduce U.S. 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," Joe Fitzgerald, group president, Cardiology, Boston Scientific, told the press. "These enhancements to our WATCHMAN FLX technology will enable efficiency during implant procedures and allow physicians to optimize treatment for their patients."
WATCHMAN FLX Pro maintains critical characteristics of WATCHMAN FLX, including the fully rounded design that enables physicians to safely enter and maneuver in the left atrial appendage. It can also be fully recaptured, repositioned, and redeployed for precise placement, and the frame design allows optimal device engagement with tissue for long-term stability and a faster, more complete seal, the company said.
The device is currently being studied in the WATCHMAN FLX Pro CT study, a single-center premarket study using multiple imaging modalities to assess post-procedural device tissue coverage and the relationship, if any, to clinical outcomes.
The technology aims to reduce stroke risk in patients with non-valvular atrial fibrillation (NVAF) needing an alternative to oral anticoagulation therapy. The device now tous a polymer coating, visualization markers, and a broader size matrix.
The WATCHMAN FLX LAAC device was approved in July 2020 and used in almost 190,000 of the over 300,000 WATCHMAN procedures successfully completed to date globally, according to Boston Scientific.
WATCHMAN FLX Pro has a coating engineered to reduce device-related thrombus and enable faster, controlled healing and endothelization of the device surface. Further, new visualization markers aim to enhance device placement for optimal sealing around the LAA. The device is also available in a new 40mm size option.
"We are pleased to introduce U.S. 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," Joe Fitzgerald, group president, Cardiology, Boston Scientific, told the press. "These enhancements to our WATCHMAN FLX technology will enable efficiency during implant procedures and allow physicians to optimize treatment for their patients."
WATCHMAN FLX Pro maintains critical characteristics of WATCHMAN FLX, including the fully rounded design that enables physicians to safely enter and maneuver in the left atrial appendage. It can also be fully recaptured, repositioned, and redeployed for precise placement, and the frame design allows optimal device engagement with tissue for long-term stability and a faster, more complete seal, the company said.
The device is currently being studied in the WATCHMAN FLX Pro CT study, a single-center premarket study using multiple imaging modalities to assess post-procedural device tissue coverage and the relationship, if any, to clinical outcomes.