Cerevasc has announced the receipt of investigational testing authorisation (ITA) from Health Canada for the STRIDE trial—a clinical study evaluating the company’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 ventriculoperitoneal (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 postoperative complications for patients living with this progressive neurological condition,” said Vitor Mendes Pereira (St Michael’s Hospital, Toronto, Canada). “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 described in a Cerevasc press release as “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 chief executive officer (CEO) of Cerevasc. “Authorisation 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.”
