The new European approval enables the use of the embolic protection device in procedures beyond transcatheter aortic valve implantation (TAVI).
AorticLab designed FLOWer to maintain secure anchoring within the aortic arch. It aims to provide full-body protection, covering the brain, kidneys and peripheral circulation during TAVI and beyond. The device ensures rapid, straightforward and firm placement within the aortic arch. By capturing debris and substantially diminishing the risk of embolic events, it fosters enhanced safety and effective execution.
The new CE mark helps the company bring the protection device to more patients across several transcatheter procedures. It originally obtained CE mark certification under the EU Medical Device Regulation in early 2024. The device has since been used in complex procedures in several European countries.
“From day one, FLOWer was designed with a clear purpose: helping protect patients at high risk of stroke,” the company said on LinkedIn. “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. This achievement reflects what drives us every day: listening to clinicians, embracing innovation and developing solutions that can make a meaningful difference in patient care.”
