AorticLab has received an expanded CE mark for its FLOWer embolic protection device, allowing broader use in transcatheter cardiovascular procedures beyond TAVI.
The device is designed to be deployed in the aortic arch, where it captures debris during procedures to reduce the risk of embolic events affecting the brain, kidneys, and peripheral circulation. The expansion builds on its initial CE mark granted in 2024 and earlier clinical use across Europe.
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AorticLab said the broader indication will help extend protection to more patients undergoing minimally invasive cardiovascular interventions.
The company said:
“From day one, FLOWer was designed with a clear purpose: helping protect patients at high risk of stroke. Expanding its use to additional transcatheter procedures allows us to bring this protection to even more patients and address clinical needs identified by physicians in their daily practice.”
The expanded approval reinforces FLOWer’s role in improving safety during structural heart and other transcatheter procedures.
