Want to learn more about Keystone Heart and our future plans of protecting the health of all those in need of surgery for heart conditions?
A Randomized Evaluation of the TriGUARD 3™ Cerebral Embolic Protection Device to Reduce the Impact of Cerebral Embolic Lesions after Transcatheter Aortic Valve Implantation
To learn more, visit the study information page at www.ClinicalTrials.gov.
Protect Your Brain While Treating the Heart
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.
Keystone Heart aspires to be the world leader in cerebral embolic protection (CEP) during cardiovascular procedures.
To develop and manufacture novel devices that protect the brain from emboli to reduce the risk of brain infarcts during transcatheter aortic valve replacement (TAVR), atrial fibrillation ablation (AF ablation) and other structural heart procedures.
Preserving brain reserve during medical procedures is a key component to procedural success and patient care.
Want to see what we’re all about?
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
The TriGUARD 3™ Cerebral Embolic Protection Device is CE marked. Approved for investigational use only in the US, not cleared by the US FDA.
Clinical Trials moving TriGuard™ Cerebral Embolic Protection Device forward
DEFLECT I clinical data presented at PCR 2013 demonstrated a significant reduction of over 60% of new brain lesion volume during protected TAVR procedures using TriGuard™ Cerebral Embolic Protection Device, compared with historical data on unprotected TAVR procedures.
DEFLECT II This study aims to evaluate the safety and performance of the new embolic deflection device TriGuard™ Cerebral Embolic Protection Device HDH in patients undergoing TAVR.
DEFLECT III a multi-center, randomized clinical trial, conducted in 13 centers across Europe and Israel, is closed. Results have been published.
NEURO-TAVI ACC and EuroPCR Benefits of TriGuard™ Cerebral Protection Device During TAVR.
REFLECT a multi-center, randomized clinical trial of the TriGUARD™3 Cerebral Embolic Protection Device to reduce the impact of cerebral embolic lesions after TAVR. To learn more, visit: www.ClinicalTrials.gov, study identifier: NCT02536196.
Follow the progress of the TriGUARD 3™ Cerebral Embolic Protection Device in clinical trials, studies, and other developments.