CereVasc has secured the US Food and Drug Administration (FDA) investigational device exemption (IDE) approval to start the STRIDE study of the CereVasc eShunt System for the treatment of normal pressure hydrocephalus (NPH).
eShunt System, which is CereVasc’s initial product, adopts a percutaneous transvenous-transdural approach to the central nervous system.
The investigational system aims to offer the first minimally invasive treatment for communicating hydrocephalus (CH), potentially improving the existing standard of care.
It has an endovascularly implantable cerebral spinal fluid (CSF) shunt and delivery components for CH treatment.
The STRIDE study will assess the safety and effectiveness of the eShunt System in treating patients with NPH compared to the current standard of care, which is the ventriculo-peritoneal (VP) shunt.
Charles Matouk, neurovascular surgery chief at Yale New Haven Health, will be the principal investigator for the STRIDE study.
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 NPH.
“We believe there is a significant unmet need in the treatment of NPH, and we are grateful for the work of our clinician collaborators, advisers and partners to develop this protocol.”
The latest development comes after CereVasc treated the first patient in a pilot study of the eShunt system under the FDA’s IDE approval in August 2022.
In September last year, the medical device company secured a separate FDA IDE supplement to expand the clinical trials of its next-generation eShunt System in the same patient population.
The Gen2 eShunt System has been engineered to streamline device preparation, elevate the system’s user-friendliness, and maintain the performance of the eShunt Implant.
