CereVasc, Inc. Receives FDA Breakthrough Device Designation for the eShunt® System for Use in Pediatric Patients

Breakthrough Device Designation supported by original research recently published in the Journal of NeuroInterventional Surgery

BOSTON, April 23, 2025 /PRNewswire/ -- CereVasc, Inc., a clinical-stage, medical device company developing novel treatments for neurological diseases, today announced it has received its second Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its investigational eShunt System. This Breakthrough Device Designation is for the treatment of communicating hydrocephalus in pediatric patients aged 12 and older. The Breakthrough Device Designation was supported by data generated during pilot clinical studies of the device, as well as original research published in the Journal of NeuroInterventional Surgery.

The research, conducted at Texas Children's Hospital and Oregon Health and Sciences University, retrospectively analyzed two cohorts of 50 consecutive patients who underwent high-resolution brain MRI. Measurements of the IPS (inferior petrosal sinus) and CPAC (cerebellopontine angle cistern) were evaluated using established anatomical criteria to assess the feasibility of safe eShunt System implantation. Regression analyses assessed the relationship between patient age and IPS/CPAC measurements.

The results demonstrated that, based on previously established anatomical criteria, endovascular shunt placement was feasible in 67% of the 100 pediatric patients evaluated. There were no statistically significant age-based differences in eligibility (P=0.57). In conclusion, the majority of patients over one year of age met the IPS and CPA anatomical criteria for placement of the eShunt System.

"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. "We are encouraged and committed to making the eShunt System available to as many patients as possible living with this debilitating disease."

CereVasc reported in early February 2025, results from a US investigational study in 30 elderly patients treated for Normal Pressure Hydrocephalus with its eShunt System, in which the Primary Safety and Primary Efficacy Endpoints were both achieved.

At the 90-day Primary Endpoint, no (0%) Serious Adverse Events related to the study device or procedure, and no (0%) Unanticipated Adverse Device Effects were reported. Additionally, 97% (29/30) of patients treated demonstrated improvement in the 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), and improvement in urinary symptoms as measured by the Neurogenic Bladder Symptom Score (NBSS).

The designation will enable priority review and enhanced communication with FDA during the clinical trial and regulatory review process for a pediatric indication for the eShunt System.

About Normal Pressure Hydrocephalus
Normal pressure hydrocephalus (NPH) is most commonly seen in adults aged 60 or over. The Hydrocephalus Association estimates that 800,000 older Americans may be living with NPH, and it is estimated that more than 80% of cases remain unrecognized or untreated. Without appropriate diagnostic testing, NPH is often misdiagnosed as Alzheimer's disease or Parkinson's disease, the result of a stroke, or other neurodegenerative conditions. Sometimes the symptoms are mistakenly attributed to "normal aging." NPH is, however, one of the few treatable forms of dementia.

About CereVasc, Inc.
Located in Massachusetts' healthcare hub, CereVasc, Inc., is a clinical stage, medical device company focused on the development of novel, minimally invasive treatments for patients with neurological diseases. Its initial product, the eShunt System, encompasses first-ever, groundbreaking percutaneous transvenous-transdural access to the central nervous system intended to enable the first minimally invasive treatment for communicating hydrocephalus (CH). The eShunt device concept originated from Tufts Medical Center physicians Carl Heilman, MD, Neurosurgeon and Chair Emeritus of Neurosurgery, and Adel Malek, MD, PhD, Chief of Neurovascular Surgery and Director of Cerebrovascular and Endovascular Neurosurgery. The patented eShunt System includes an endovascularly implantable cerebral spinal fluid shunt and delivery components, which are designed to treat CH without invasive surgery. For additional information, please visit our website at www.cerevasc.com.

The eShunt^® Device is an investigational device and has not been approved by FDA or any other regulatory agency for commercial sale. Its safety and effectiveness have not yet been fully established.

Company Contact:
DJ Cass
CereVasc, Inc.
[email protected]

Media Contacts:
Ethan Metelenis
Precision AQ
[email protected]

Christina Renfroe
Precision AQ
[email protected]

SOURCE CereVasc