CereVasc Earns 2nd FDA Breakthrough Nod for eShunt, Covering Pediatric Use

CereVasc has earned its second Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its investigational eShunt system.

This breakthrough nod covers treating communicating hydrocephalus in pediatric patients aged 12 and up. The designation was supported by data from pilot clinical studies of eShunt, as well as original research published in the Journal of NeuroInterventional Surgery.

The research retrospectively analyzed two cohorts of 50 consecutive patient who underwent high-resolution brain MRI. IPS (inferior petrosal sinus) and CPAC (cerebellopontine angle cistern) measurements were assess using established anatomical criteria to evaluate safe eShunt implantation’s feasibility. Regression analyses evaluated the relationship between age and IPS/CPAC measurements.

Results showed endovascular shunt placement was feasible in 67% of the 100 pediatric patients assessed. There were no statistically significant age-based differences in eligibility.

In early February, results from a U.S. investigational study in 30 elderly patients treated for normal pressure hydrocephalus (NPH) with eShunt achieved primary safety and efficacy endpoints. No serious adverse events or unanticipated adverse device effects were reported.

97% of patients showed improvement in NPH clinical symptoms, including gait improvement measured by the Timed Up and Go (TUG) test, cognitive improvement measured by the Montreal Cognitive Assessment (MoCA), and improvement in urinary symptoms as measured by the Neurogenic Bladder Symptom Score (NBSS).

“The recognition of Breakthrough Device Designation for the eShunt System in pediatric aged patients demonstrates the profound need for treatment innovation in this patient population and reinforces the potential safety and efficacy benefits that have already been observed with this minimally invasive, endovascular approach,” said Dan Levangie, chairman and CEO of CereVasc. “We are encouraged and committed to making the eShunt System available to as many patients as possible living with this debilitating disease.”