Pediatric use case gets spotlight in hydrocephalus treatment
Boston-based CereVasc has received a second FDA Breakthrough Device Designation for its eShunt System, this time for treating communicating hydrocephalus in pediatric patients aged 12 and older.
Key Highlights:
- eShunt previously earned breakthrough status in August for normal pressure hydrocephalus (NPH).
- It features a minimally invasive, endovascular shunt with a self-expanding nitinol anchor.
- Early trials show 67% feasibility in 100 pediatric patients, with no significant age-based anatomical limitations.
- The system is currently under investigation in the STRIDE pivotal study launched earlier this year.
The designation brings priority FDA review and increased regulatory support, paving the way for potential accelerated approval.
“This highlights the critical need for innovation in pediatric hydrocephalus treatment,” said CEO Dan Levangie, citing encouraging safety and efficacy signals from pilot studies.
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