EU gives CE Mark for Triguard cerebral protection device

The EU has given the TriGuard cerebral protection device, from Keystone Heart, CE Mark approval, for use to minimize the risk of brain damage during Transcatheter Aortic Valve Replacement (TAVR). TriGuard is the only device designed to cover all three aortic cerebral branches to minimize the risk of cerebral damage during TAVR and other cardiovascular procedures.

Data presented at EuroPCR, demonstrated a significant reduction of new brain lesion volume during TAVR using TriGuard Cerebral Protection Device, compared with historical data on unprotected TAVR procedures. The clinical data shows that Maximum Total Lesion Volume was 95% smaller and Average Total Lesion Volume was 57% smaller when compared with historical references.