CereVasc eShunt Receives Breakthrough Device Designation for Use in Pediatric Patients to Treat Communicating Hydrocephalus

April 23, 2025—CereVasc, Inc. announced it has received its second FDA Breakthrough Device designation for the investigational eShunt system. This designation is for use in the treatment of communicating hydrocephalus in pediatric patients aged ≥ 12 years.

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

According to CereVasc, the new designation was supported by data generated in pilot clinical studies of the device, as well as in an original investigation conducted at Texas Children’s Hospital in Houston, Texas, and Oregon Health and Sciences University in Portland, Oregon. On March 31, results of the study were published online by Marco Colasurdo, MD, et al in Journal of NeuroInterventional Surgery.

As summarized in the press release, the study retrospectively analyzed two cohorts of 50 consecutive patients who underwent high-resolution brain MRI. Measurements of the inferior petrosal sinus (IPS) and cerebellopontine angle cistern (CPAC) 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 = .57). The majority of patients aged > 1 year met the IPS and CPA anatomical criteria for placement of the eShunt system, stated the company.

On February 5, CereVasc reported initial results of its United States pilot clinical study of the eShunt system in the treatment of elderly patients with normal pressure hydrocephalus.

The eShunt is an investigational device and has not been approved by FDA or any other regulatory agency for commercial sale, advised CereVasc.