CereVasc has secured a second breakthrough device designation from the US Food and Drug Administration (FDA) for its investigational eShunt System.
The latest designation covers the system’s proposed use in treating communicating hydrocephalus in children aged 12 years and older. It builds upon the company’s earlier designation granted in August 2024 for the treatment of normal pressure hydrocephalus (NPH) in adults.
CereVasc chairman and CEO Dan Levangie said: “The recognition of breakthrough device designation for the eShunt System in paediatric 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.
“We are encouraged and committed to making the eShunt System available to as many patients as possible living with this debilitating disease.”
The second breakthrough device status for the device was driven by clinical insights generated through pilot trials and original research published in the Journal of NeuroInterventional Surgery.
The study was conducted jointly by Texas Children’s Hospital and Oregon Health and Sciences University. Investigators retrospectively assessed 100 paediatric cases involving high-resolution MRI scans, focusing on anatomical suitability for endovascular shunt placement.
The analysis evaluated two specific cranial structures, the inferior petrosal sinus (IPS) and cerebellopontine angle cistern (CPAC), based on predetermined safety criteria.
Findings indicated that 67% of the paediatric patients met the anatomical thresholds for implantation of the eShunt device.
The results further showed no significant age-based variation in eligibility, with statistical analysis reporting a p-value of 0.57. Most children over one year of age qualified for the procedure based on these anatomical parameters.
In February 2025, CereVasc initiated enrolment in its STRIDE clinical trial, a comparative study evaluating the eShunt System against the conventional ventriculo-peritoneal (VP) shunt. The first patient was treated at VCU Health in Richmond, Virginia, and additional trial sites have since been activated across the US.
STRIDE is designed as a multi-centre, randomised controlled trial aimed at measuring the safety and efficacy of the eShunt approach in patients with NPH. According to the company, outcomes from the STRIDE study are expected to support a premarket approval (PMA) submission to the FDA.
In parallel to paediatric developments, CereVasc had previously released results from a US-based investigational study involving 30 older adults with NPH. The findings revealed that the eShunt System achieved both its primary safety and efficacy endpoints.
The 90-day analysis showed that none of the participants experienced serious adverse events related to the procedure or the device, nor were any unanticipated adverse device effects reported.
Clinical improvements were also noted across multiple areas. Among the participants, 97% exhibited symptomatic relief, with mobility enhancement demonstrated through the Timed Up and Go (TUG) test, cognitive improvement via the Montreal Cognitive Assessment (MoCA), and urinary function gains tracked by the Neurogenic Bladder Symptom Score (NBSS).
The eShunt System is designed to offer a less invasive alternative to traditional hydrocephalus treatment. It includes an endovascularly implanted cerebrospinal fluid (CSF) shunt and a proprietary delivery mechanism.
The core aim is to reduce the need for open surgical procedures in managing CSF accumulation within the brain’s ventricles, a common issue in both communicating hydrocephalus and NPH.
By securing a breakthrough device designation specifically for paediatric patients, CereVasc now benefits from expedited communication pathways with the FDA. The status allows for priority review and additional regulatory support during trial phases and application reviews related to the children’s indication.
