FDA authorization enables clinical investigation of a fundamentally different approach for patients with early symptomatic Alzheimer’s disease

Study design investigates whether CSF diversion may support brain’s natural process for clearing neurotoxins associated with AD 

BOSTON, Oct. 29, 2026 /PRNewswire/ — CereVasc, Inc., a clinical-stage medical device company developing novel, minimally invasive treatments for neurological diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to evaluate the eShunt System in patients with early symptomatic Alzheimer’s disease (AD).

AD is the most common cause of dementia, affecting an estimated 7.4 million Americans age 65 and older, as well as millions of family members and caregivers. Without medical breakthroughs that prevent, delay, or cure the disease, that number is projected to reach 13.8 million by 2060, underscoring the need for continued innovation.

The eShunt System is a novel, minimally invasive, endovascular shunt designed to divert cerebrospinal fluid (CSF) to the venous system. CereVasc will investigate whether the eShunt System may support the brain’s natural process for clearing neurotoxins associated with AD by increasing CSF cycling.

“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,” said Dr. Adnan Siddiqui, Vice Chairman of Neurosurgery at SUNY Buffalo’s Jacobs School of Medicine and CEO of the Jacobs Institute. “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 authorization to evaluate the eShunt System in Alzheimer’s disease marks an exciting chapter for CereVasc,” said Tony Kingsley, President and Chief Executive Officer 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 enrollment in STRIDE, its pivotal randomized control trial.

About CereVasc, Inc. 
Located in Massachusetts’ healthcare hub, CereVasc, Inc. is a clinical-stage medical device company focused on developing novel, minimally invasive treatments for patients with neurological diseases. Its initial product, the eShunt System, employs an innovative percutaneous transvenous-transdural approach to the central nervous system and is intended to enable the first minimally invasive treatment for communicating hydrocephalus (CH). The patented eShunt System includes an endovascularly implantable cerebrospinal fluid shunt and delivery components designed to treat CH without invasive surgery. For additional information, please visit www.cerevasc.com.  

The eShunt System is an investigational device and has not been approved by the FDA or any other regulatory agency for commercial sale. Its safety and effectiveness have not yet been established.

Media Contact:

Tiffany Weil
CereVasc, Inc.
tiffanyweil@cerevasc.com 

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SOURCE CereVasc, Inc.