Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

FDA approves CereVasc’s eShunt system study for hydrocephalus

The US Food and Drug Administration (FDA) has authorized investigational device exemption (IDE) for CereVasc to commence the STRIDE pivotal study, evaluating its eShunt system for treating normal pressure hydrocephalus (NPH). This study aims to compare the safety and efficacy of the eShunt system with the current standard of care, the ventriculoperitoneal (VP) shunt.

The eShunt system comprises an endovascularly implantable cerebral spinal fluid shunt (CSF) and associated delivery components. Its design aims to eliminate the necessity for general anesthesia, invasive surgery, prolonged hospital stays, and post-procedural pain management. The system targets a significant reduction in failures associated with ventriculoperitoneal shunt systems, such as catheter obstruction, over-drainage, and infection.

The eShunt System facilitates percutaneous transvenous-transdural access to the central nervous system (CNS). In June 2023, CereVasc partnered with LianMedical to introduce its eShunt System and associated products in China.