The company said data generated during pilot clinical studies of the device supported the breakthrough device designation. This designation enables priority review and enhanced communication with the FDA during the clinical trial and premarket review process.

eShunt offers a minimally invasive endovascular treatment option. It has the potential to result in benefits over the current gold-standard treatment, according to CereVasc. It includes an endovascularly implantable cerebral spinal fluid (CSF) shunt and delivery components.

CereVasc initiated a pilot study of its eShunt system under investigational device exemption (IDE) in August 2022. Last September, it picked up a separate IDE supplement for a study of the next-generation eShunt system.