CereVasc Nabs FDA IDE Nod for eShunt Trial to Treat Hydrocephalus

CereVasc, a clinical-stage company developing treatments for neurological diseases, has earned approval for its investigational device exemption (IDE) study from the U.S. Food and Drug Administration (FDA) to begin its “Pivotal Study to Evaluate the Safety and Effectiveness of the CereVasc eShunt System in the Treatment of Normal Pressure Hydrocephalus” (STRIDE trial).
 
This IDE approval lets the company initiate the groundbreaking STRIDE study, which will compare safety and efficact of the novel eShunt system to treat patients with normal pressure hydrocephalus to treatment with the current standard of care. The current standard of care for this condition is a ventriculo-peritoneal (VP) shunt.
 
Charles Matouk, MD, chief of neurovascular surgery at Yale New Haven Health, will be the principal investigator of the STRIDE study. “I am thrilled to participate in and lead the STRIDE study. 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,” said Dr. Matouk.
 
“FDA approval of the STRIDE study is a significant milestone for CereVasc, added Dan Levangie, CereVasc’s chairman and CEO. “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 (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, advisors and partners to develop this protocol.”

About the CereVasc eShunt system

eShunt represents the first percutaneous, transvenous-transdural access to the central nervous system. It allows the first minimally invasive treatment for communicating hydrocephalus and an improvement to the current standard of care.
 
The device’s concept came from Tufts Medical Center physicians Carl Heilman, MD, Neurosurgeon-in-Chief and Chair of Neurosurgery, and Adel Malek, MD, Ph.D., Chief of Neurovascular Surgery and Director of Endovascular Neurosurgery.
 
It includes an endovascularly implantable cerebral spinal fluid (CSF) shunt and delivery components, which are designed to treat CH without invasive surgery.