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Cerebral Protection Device Used During TAVR Does Not Meet Primary Endpoint

from Cardiovascular Business

A randomized trial found that an investigational cerebral protection device captured embolic debris in 99 percent of patients undergoing transcatheter aortic valve replacement (TAVR) and did not change their neurocognitive function. However, the study did not meet its primary efficacy endpoint, which was the reduction in median new lesion volume in protected territories as assessed by MRI two to seven days after patients underwent TAVR. more

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