CereVasc Receives Health Canada Investigational Testing Authorization for STRIDE Clinical Trial of the eShunt® System

The STRIDE trial is actively enrolling at multiple sites in the United States and Argentina for the treatment of elderly patients with Normal Pressure Hydrocephalus (NPH)

BOSTON, June 18, 2025 /PRNewswire/ -- CereVasc, Inc., a clinical-stage medical device company developing novel treatments for neurological diseases, announced today that it has received Investigational Testing Authorization (ITA) from Health Canada to conduct the STRIDE trial, a clinical study evaluating CereVasc's eShunt System as a treatment for normal pressure hydrocephalus (NPH).

The trial will evaluate the safety and effectiveness of the eShunt System versus the current standard of care, the ventriculo-peritoneal (VP) shunt, in draining accumulated cerebrospinal fluid from the brain in elderly patients. The results of the STRIDE trial will serve as the basis for CereVasc's anticipated submission to regulatory agencies for approval to market the eShunt System.

"A minimally invasive, endovascular approach to treating NPH has the potential to improve recovery times and reduce the possibility of post-operative complications for patients living with this progressive, neurological condition," said Dr. Vitor Mendes Pereira, Neurosurgeon and Director of Endovascular Research and Innovation at St. Michael's Hospital. "I am encouraged by initial study results of the eShunt System and look forward to participating in the STRIDE trial, with the goal of improving care and clinical outcomes for patients."

The eShunt System is the only minimally invasive, endovascular shunt and the first new treatment option developed for NPH since the VP shunt was introduced more than 60 years ago.

"This marks another important milestone for patients and caregivers living with NPH, as the eShunt System is designed to make treatment accessible for more patients while potentially improving outcomes," stated Dan Levangie, Chairman and CEO of CereVasc. "Authorization from Health Canada for the STRIDE clinical trial brings us closer to our mission of improving the quality of life globally for people living with this debilitating neurological condition."

For more information, please visit https://nphstridestudy.com/.

About CereVasc, Inc.

Located in Massachusetts' healthcare hub, CereVasc, Inc., is a clinical stage, medical device company focused on the development of novel, minimally invasive treatments for patients with neurological diseases. Its initial product, the eShunt System, encompasses first-ever, groundbreaking percutaneous transvenous-transdural access to the central nervous system intended to enable the first minimally invasive treatment for communicating hydrocephalus (CH). The eShunt device concept originated from Tufts Medical Center physicians Carl Heilman, MD, Neurosurgeon and Chair Emeritus of Neurosurgery, and Adel Malek, MD, PhD, Chief of Neurovascular Surgery and Director of Cerebrovascular and Endovascular Neurosurgery. The patented eShunt System includes an endovascularly implantable cerebral spinal fluid shunt and delivery components, which are designed to treat CH without invasive surgery. For additional information, please visit our website at www.cerevasc.com.

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

Company Contacts: 

DJ Cass

CereVasc, Inc.

djcass@cerevasc.com

Media Contacts: 

Ethan Metelenis

Precision AQ

Ethan.Metelenis@precisionaq.com

Christina Renfroe

Precision AQ

Christina.Renfroe@precisionaq.com

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SOURCE CereVasc

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