CereVasc has concluded patient enrolment in its STRIDE pivotal study, assessing the safety and effectiveness of the investigational eShunt System for normal pressure hydrocephalus (NPH).
The enrolment was completed across 32 clinical sites, with the study now progressing through the remaining treatment and follow-up steps for patients already consented.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The multi-centre, prospective, controlled, randomised trial will compare the eShunt System directly with the current standard treatment, the ventriculoperitoneal (VP) shunt, in elderly patients diagnosed with NPH.
Its outcomes are intended to form the clinical basis for CereVasc’s planned premarket approval (PMA) submission to the US Food and Drug Administration (FDA).
CereVasc stated that NPH affects an estimated 800,000 people in the US and can result in progressive motor impairment, cognitive difficulties, and urinary incontinence. Traditionally, the condition is treated with brain surgery to insert a conventional shunt.
With recruitment completed at the trial’s sites in Argentina, Canada, and the US, the study will continue with patients who consented before the enrolment closure.
Remaining treatment and follow-up activities are planned to conclude by the end of July, after which topline results are anticipated following the conclusion of the primary endpoints.
CereVasc chairman and CEO Dan Levangie said: “Completing patient enrolment in STRIDE is the most important clinical milestone in CereVasc’s history and brings us closer to generating the data needed to support a PMA submission.
“We are grateful to the investigators, clinical site teams, patients, and CereVasc employees who have made this study possible.
“As consented patients complete the remaining treatment and follow-up process, our focus remains on advancing a minimally invasive option for the hundreds of thousands of people living with NPH.”
Earlier this month, CereVasc raised $85m in a Series C round, providing the company with funds to support the ongoing development of its eShunt system for NPH treatment.
