Keystone Heart’s TriGuard is a cerebral protection device specifically designed to provide full coverage to all aortic arch takeoffs. By protecting all brain territories, the TriGuard Cerebral Protection Device is designed to minimize the risk of cerebral damage during TAVR (Transcatheter Aortic Valve Replacement) and other cardiovascular procedures.
This round of financing will be used by the Caesarea based company to conduct a European multi-center, randomized clinical trial during TAVR procedures, as well as a planned US Food and Drug Administration (FDA) IDE study. These studies will enable further assessment of the efficacy and performance of the TriGuard™ and should generate additional clinical data to support the TriGuard commercialization globally. Keystone Heart is planning additional studies to leverage the TriGuard product pipeline in TAVR and other cardiovascular indications.
Clinical data already presented has demonstrated a significant reduction of over 60% of new brain lesion volume during protected TAVR procedures using TriGuard.
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