CE mark for TAVI cerebral protection device


Keystone Heart has announced that it can now commercially market its cerebral protection device, Triguard, for use in transcatheter aortic valve implantation (TAVI) procedures as the device has been awarded the CE mark. 

According to a company press release, Triguard is the only device designed to cover all three aortic cerebral branches to minimise the risk of cerebral damage during TAVI and other cardiovascular procedures. It is also the only system designed for placement via one of two femoral artery access ports.

Data presented at EuroPCR (21–24 May, Paris, France) demonstrated a significant reduction of new brain lesion volume during TAVI using the Triguard cerebral protection device, compared with historical data on unprotected TAVI procedures. The clinical data shows that maximum total volume was 95% smaller and average total lesion volume was 57% smaller when compared with historical references.

Andreas Baumbach, consultant cardiologist at University Hospitals Bristol, UK, and honorary reader in Cardiology at the University of Bristol, UK, said: “Triguard is the most sophisticated cerebral embolic protection device currently available. It has the potential to become a routine preventive measure in TAVI and other cardiovascular procedures associated with embolic lesions. European approval of the Triguard device is an important advancement in patient care.”