The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for CereVasc to initiate the STRIDE pivotal study of its eShunt system for treating normal pressure hydrocephalus (NPH).

This study will compare the eShunt system’s safety and efficacy against the current standard of care, the ventriculoperitoneal (VP) shunt.

The system includes an endovascularly implantable cerebral spinal fluid shunt (CSF) and associated delivery components, which will help avoid the need for general anaesthesia, invasive surgery, extended hospitalisation and post-procedure pain management.

It is intended for the significant reduction of failures linked to ventriculoperitoneal shunt systems such as catheter obstruction, over-drainage and infection.

The eShunt System provides percutaneous transvenous-transdural access to the central nervous system.

CereVasc chairman and CEO Dan Levangie said: “FDA approval of the STRIDE study is a significant milestone for CereVasc. The team has worked tirelessly to develop the eShunt System and we believe STRIDE will result in clinical data to support the use of our system in the treatment of patients with normal pressure hydrocephalus.

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“We believe there is a significant unmet need in the treatment of NPH, and we are grateful for the work of our clinician collaborators, advisors and partners to develop this protocol.”

Yale New Haven Health neurovascular surgery chief Charles Matouk will serve as principal investigator of the study.

Matouk said: “Our experience with the eShunt System in pilot clinical studies has been extremely encouraging and I believe the STRIDE study has the potential to provide us the information we need to begin more widespread use of the eShunt System.”

In June 2023, CereVasc partnered with LianMedical to introduce its eShunt System and related products in China.