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Keystone Heart obtains CE Mark approval for cerebral protection device

Keystone Heart, a developer and manufacturer of cerebral protection devices, has received CE Mark approval for its TriGuard cerebral protection device, designed to cover all three aortic cerebral branches to minimize the risk of cerebral damage during transcatheter aortic valve replacement (TAVR) and other cardiovascular procedures.

It is reportedly the only system designed for placement via one of two femoral artery access ports.

It is designed to accommodate anatomical variations of the aortic arch.

The cerebral protection device uses a Nitinol frame and mesh – flexible and atraumatic, yet robust and sturdy.

University Hospitals Bristol, UK consultant cardiologist and honorary reader in cardiology at the University of Bristol Dr Andreas Baumbach said TriGuard is the most sophisticated cerebral embolic protection device currently available.

"The device has the potential to become a routine preventive measure in TAVI and other cardiovascular procedures associated with embolic lesions," Dr Baumbach added.

The recent data demonstrates considerable reduction of new brain lesion volume during protected TAVR procedures performed with the TriGuard medical device.

The device is currently not available for sale in the US.