TriGUARD 3™ by Keystone Heart
The Only Cerebral Protection Device Designed to Cover all Three Major Aortic Vessels
Keystone Heart’s TriGUARD 3™ is designed to provide full coverage of all three major aortic vessels to minimize the risk of cerebral damage during TAVR. The TriGUARD 3™ 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 TriGUARD 3™ Cerebral Protection Device
Components/Structure
TriGUARD 3™ Deflector
Device preparation – Simplified
