CereVasc Gains Breakthrough Status for eShunt

FDA has granted CereVasc a breakthrough device designation for its investigational eShunt System and its use in treating communicating hydrocephalus in pediatric patients aged 12 years and older. The action was supported by data generated during pilot clinical studies, as well as original research published in the Journal of NeuroInterventional Surgery.

The research was conducted at Texas Children's Hospital and Oregon Health and Sciences University to assess the feasibility of safe eShunt System implantation, according to the company. Data found that, “based on previously established anatomical criteria, endovascular shunt placement was feasible in 67% of the 100 pediatric patients evaluated,” it says.

CereVasc describes the device as an endovascular cerebrospinal fluid shunt system designed to treat communicating hydrocephalus, specifically normal pressure hydrocephalus. It aims to provide an alternative to traditional surgical shunt placement, offering potential benefits such as reduced invasiveness and recovery time.