CereVasc Inc. has received Investigational Testing Authorization (ITA) from Health Canada to conduct a clinical study of its eShunt System treatment for normal pressure hydrocephalus (NPH).

The STRIDE trial will evaluate the safety and effectiveness of CereVasc’s eShunt System versus the current care standard—the ventriculo-peritoneal (VP) shunt—in draining accumulated cerebrospinal fluid from the brain in elderly patients. The trial results will serve as the basis for CereVasc’s regulatory submission for market approval of 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,” CereVasc Chairman/CEO Dan Levangie stated. “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.”

Located in Massachusetts’ healthcare hub, CereVasc is a clinical stage, medical device company developing minimally invasive treatments for patients with neurological diseases. Its initial product, the eShunt System, encompasses the first-ever 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, M.D., neurosurgeon and chair Emeritus of Neurosurgery; and Adel Malek, M.D., Ph.D., 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.

eShunt is an investigational device and has not been approved by any regulatory agency for commercial sale.