Cerevasc announced recently that it has received approval from Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT) to initiate the STRIDE trial—a clinical study evaluating the company’s eShunt system as a treatment for normal-pressure hydrocephalus (NPH).
This 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, as stated in a company press release.
“Treatment is essential for patients with NPH, as this progressive, life-threatening form of communicating hydrocephalus can cause symptoms including cognitive dysfunction, gait disturbance and urinary incontinence,” said Pedro Lylyk (Clinica la Sagrada Familia, Buenos Aires, Argentina), co-lead investigator of the STRIDE trial. “Positive findings from the STRIDE trial will broaden access to NPH treatment in Argentina, as more patients would likely be eligible for a minimally invasive procedure than for open brain surgery.”
The eShunt system is touted by Cerevasc 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.
“We’re pleased that ANMAT has approved this study, enabling us to move closer to a new standard in NPH treatment designed to reduce recovery time and complications for patients,” stated Dan Levangie, chairman and chief executive officer (CEO) of Cerevasc. “The launch of the STRIDE trial in Argentina represents a key milestone in Cerevasc’s mission to improve the quality of life for people around the world who are affected by this devastating neurological condition.”
