TriGUARD 3™ Cerebral Embolic Protection Device by Keystone Heart
The Only Cerebral Embolic Protection Device Designed to Cover all Three Major Aortic Vessels
Keystone Heart’s TriGUARD 3™ Cerebral Embolic Protection Device is designed to provide full coverage of all three major aortic vessels to minimize the risk of cerebral damage during TAVR. The TriGUARD 3™ Cerebral Embolic Protection Device device is shaped to accommodate anatomic variations of the aortic arch. Formed to withstand potential interface with the TAVR delivery system and other procedure related accessories, it uses a Nitinol® frame and mesh — flexible and atraumatic, yet robust and sturdy.
The TriGUARD 3™ Cerebral Embolic Protection Device is placed via one of two femoral artery access ports typically used in TAVR, thereby eliminating the need for a third puncture site. It is designed to deploy rapidly and self-position through a small 8F catheter, and it provides stable, atraumatic protection with simple retrieval.
CAUTION – The TriGUARD 3™ Cerebral Embolic Protection Device is CE marked. Approved for investigational use only in the US, not cleared by the US FDA.
The TriGUARD 3™ Cerebral Embolic Protection Device
- Self-positioning, self-stabilizing
- Polymeric mesh (pore size 115 x 145 µm)
- 8 Fr OTW delivery
- Designed to protect all three major arteries that supply blood to the brain
- Eliminates need for third access site during TAVI
- Removed upon completion of procedure
TAVR Procedure Animation with the TriGUARD 3™ Cerebral Embolic Protection Device
Components/Structure
TriGUARD 3™ Cerebral Embolic Protection Device
Device preparation – Simplified
