CLINICAL TRIALS

Keystone Heart’s TriGuard™ is the only cerebral protection device specifically designed to provide full coverage to all aortic arch takeoffs.

DEFELCT 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™, compared with historical data on unprotected TAVR procedures.

DEFLECT II

DEFLECT III , a multi-center, randomized clinical trial, conducted in up to 12 centers across Europe and Israel, is closed. results have been published. DEFLECT III results were also presented at EuroPCR 2015 and ACC 2015

NEUROTAVI

REFLECT, a global multi-center, randomized clinical trial of the TriGuard™ HDH Embolic Deflection Device to reduce the impact of cerebral embolic lesions after TAVR.  Enrollment will begin in the second quarter of 2016.

Study in Progress

Keystone Heart is planning additional studies to support the TriGuard™ product pipeline for TAVR and other cardiovascular indications. 
Please contact us for additional information.
The TriGuard Cerebral Protection Device is not commercially available in the USA.