Cerevasc today announced that the US Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to evaluate the company’s eShunt system in patients with early symptomatic Alzheimer’s disease.
The eShunt system is a novel, minimally invasive, endovascular shunt designed to divert cerebrospinal fluid (CSF) to the venous system. Cerevasc says it will investigate whether the eShunt system may support the brain’s natural process for clearing neurotoxins associated with Alzheimer’s disease by increasing CSF cycling.
“The FDA’s launch of the Neuroscience Advancement and Innovation Nexus [NAIN], with Alzheimer’s prevention and early intervention as its first focus, makes this study especially timely,” said Adnan Siddiqui (Jacobs School of Medicine and Biomedical Sciences, Buffalo, USA). “Investigating mechanisms to improve the brain’s clearance pathways can potentially make a big difference in disease progression and is exactly the kind of approach we need to investigate.”
“Receiving FDA authorisation to evaluate the eShunt system in Alzheimer’s disease marks an exciting chapter for Cerevasc,” added Tony Kingsley, president and chief executive officer (CEO) of Cerevasc. “We have an opportunity to build on our clinical experience with the eShunt system, work alongside leading Alzheimer’s experts, and explore its potential in a disease that affects millions of patients and families.”
Cerevasc is also evaluating the eShunt system for the treatment of normal-pressure hydrocephalus (NPH) and recently completed enrolment in STRIDE—its pivotal randomised controlled trial.
