AorticLab’s FLOWer Transcatheter Embolic Protection Device Granted CE Mark

February 12, 2024—AorticLab recently announced that its FLOWer transcatheter embolic protection device (EPD) received CE Mark certification. FLOWer is indicated for the cerebral and systemic protection of patients who are undergoing transcatheter aortic valve replacement (TAVR) procedures.

According to the company, the FLOWer transcatheter EPD is equipped with the company’s Catch&Flow technology and can capture emboli up to 60 μm in size, thus protecting the brain and peripheral organs from ischemic events during TAVR procedures.

“FLOWer will be part of the new frontier of cardiovascular medical devices; EPDs can make a difference for our patients, providing a higher and more comprehensive level of protection against embolic events during TAVR procedures,” commented Filippo Scalise, MD, in the company’s announcement. “The FLOWer medical device offers an intuitive user interface that allows for rapid device positioning and stable anchoring in the aortic arch during the procedure.” Dr. Scalise is the Principal Investigator of the NAUTILUS trial, as well as Director of the Department of Interventional Cardiology at the Policlinico of Monza, in Milan, Italy.

Approval of CE Mark will allow for the production and commercialization of the device throughout the European territory.

AorticLab also stated that they plan to initiate a European postmarket clinical study and evaluate the steps toward a clinical study to obtain United States FDA certification.