CereVasc, Inc., a Boston-based clinical-stage medical device company, announced on April 23, 2025, that its investigational eShunt System has received a second Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This designation specifically applies to the treatment of communicating hydrocephalus in pediatric patients aged 12 and older, highlighting the significant unmet need for innovative treatments in this population.
The designation was supported by promising data from pilot clinical studies and original research recently published in the Journal of NeuroInterventional Surgery. This recognition will facilitate priority review and enhanced communication with the FDA throughout the clinical trial and regulatory review process for the pediatric indication.
Research Supporting Pediatric Application
The supporting research was conducted at Texas Children's Hospital and Oregon Health and Sciences University, where investigators retrospectively analyzed two cohorts totaling 100 consecutive pediatric patients who had undergone high-resolution brain MRI. The study evaluated measurements of the inferior petrosal sinus (IPS) and cerebellopontine angle cistern (CPAC) using established anatomical criteria to assess the feasibility of safe eShunt System implantation.
Results demonstrated that endovascular shunt placement would be feasible in 67% of the pediatric patients evaluated. Importantly, researchers found no statistically significant age-based differences in eligibility (P=0.57), suggesting the approach could be viable across various pediatric age groups above one year of age.
"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 & CEO of CereVasc, Inc.
Promising Clinical Results in Adult Population
This pediatric designation follows encouraging results from a U.S. investigational study in 30 elderly patients with Normal Pressure Hydrocephalus (NPH) treated with the eShunt System. The company reported in February 2025 that both primary safety and efficacy endpoints were achieved in this adult population.
At the 90-day primary endpoint assessment, no serious adverse events related to the study device or procedure were reported, and no unanticipated adverse device effects occurred. Additionally, 97% (29/30) of treated patients demonstrated improvement in clinical symptoms of NPH, including:
- Gait improvement measured by the Timed Up and Go (TUG) test
- Cognitive improvement measured by the Montreal Cognitive Assessment (MoCA)
- Improvement in urinary symptoms as measured by the Neurogenic Bladder Symptom Score (NBSS)
The eShunt System: A Novel Approach
The eShunt System represents a significant departure from traditional hydrocephalus treatment methods. Developed by neurosurgeons at Tufts Medical Center, the system enables the first minimally invasive treatment for communicating hydrocephalus through percutaneous transvenous-transdural access to the central nervous system.
Traditional treatments for hydrocephalus typically involve surgical placement of shunts, which carry risks of infection, mechanical failure, and other complications. The eShunt System's endovascular approach could potentially reduce these risks while improving patient outcomes.
Hydrocephalus Burden and Treatment Challenges
Hydrocephalus represents a significant health burden across age groups. In adults, Normal Pressure Hydrocephalus (NPH) is most commonly seen in those aged 60 or over. The Hydrocephalus Association estimates that approximately 800,000 older Americans may be living with NPH, with more than 80% of cases remaining unrecognized or untreated.
NPH is frequently misdiagnosed as Alzheimer's disease, Parkinson's disease, stroke effects, or other neurodegenerative conditions. Sometimes symptoms are incorrectly attributed to normal aging. However, NPH is one of the few treatable forms of dementia, underscoring the importance of accurate diagnosis and effective treatment options.
In pediatric populations, hydrocephalus can significantly impact development and quality of life, making innovative and less invasive treatment approaches particularly valuable.
Regulatory Status and Future Directions
While the eShunt System has now received two Breakthrough Device Designations from the FDA, it remains an investigational device that has not yet been approved for commercial sale by the FDA or any other regulatory agency. Its safety and effectiveness continue to be evaluated through clinical studies.
The Breakthrough Device Designation program is designed to expedite the development and review of medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. This designation for pediatric use reflects the FDA's recognition of both the significant unmet need in pediatric hydrocephalus treatment and the potential of the eShunt System to address this need.
As CereVasc continues to advance the eShunt System through clinical development, the medical community awaits further data on this potentially transformative approach to treating a challenging neurological condition across the age spectrum.
