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November 4, 2026

CereVasc’s eShunt System Receives IDE Approval for Study in Early Symptomatic Alzheimer Disease

KEY TAKEAWAYS

  • The FDA approved an investigational device exemption for a study of CereVasc’s eShunt system in patients with early symptomatic Alzheimer disease.
  • The study will investigate whether increasing cerebrospinal fluid cycling with the eShunt system can support the clearance of neurotoxins associated with Alzheimer disease.
  • CereVasc is also evaluating the device for normal pressure hydrocephalus and has completed enrollment in the STRIDE pivotal randomized controlled trial.

November 4, 2026—CereVasc, Inc. announced that the FDA approved an investigational device exemption application to evaluate the company’s eShunt system in patients with early symptomatic Alzheimer disease (AD).

According to CereVasc, the study will investigate whether the eShunt system may support the brain’s natural process for clearing neurotoxins associated with AD by increasing cerebrospinal fluid (CSF) cycling.

The company stated that the minimally invasive, endovascular shunt is designed to divert CSF to the venous system. The investigational eShunt system employs a percutaneous transvenous-transdural approach to the central nervous system. It is intended to enable minimally invasive treatment for communicating hydrocephalus.

CereVasc is also evaluating the eShunt system for the treatment of normal pressure hydrocephalus and recently completed enrollment in the STRIDE pivotal randomized control trial.

“The FDA’s launch of the Neuroscience Advancement and Innovation Nexus, with Alzheimer’s prevention and early intervention as its first focus, makes this study especially timely,” commented Adnan Siddiqui, MD, in CereVasc’s press release.

Dr. Siddiqui, who Vice Chairman of Neurosurgery at SUNY Buffalo’s Jacobs School of Medicine and CEO of the Jacobs Institute in Buffalo, New York, continued, “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.”

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