The TriGUARD 3™ Cerebral Embolic Protection Device is the only CE marked device designed to cover and protect all three major cerebral aortic arch vessels during Transcatheter Heart Procedures.
Indication
The TriGUARD 3 Cerebral Embolic Protection Device is designed to minimize the risk of cerebral damage by deflecting embolic debris away from the cerebral circulation during trans-catheter heart procedures.
Intended use
Reduce cerebral embolization during transcatheter heart procedures.
Contraindications
DO NOT USE IN THE FOLLOWING CIRCUMSTANCES:
Warnings
Warnings
There are risks associated with any endovascular intervention and complications may develop. The following anticipated events have been identified as possible complications of trans-catheter procedures and these and others may be associated with the device:
In addition to the risks listed above, the potential risks specifically associated with the Keystone Heart TriGUARD 3 Cerebral Embolic Protection Device procedure includes, but may not be limited to, the following: