Keystone Heart is focused on protecting the brain from emboli to reduce the risk of brain infarcts during TAVR, atrial fibrillation ablation and other structural heart procedures.

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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 Protection Device is not commercially available. An investigational device for investigational use only. 

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

1. Rinse

2. Flush

3. Pull