Enrollment Complete in CereVasc’s eShunt System Trial

CereVasc Inc. has completed patient enrollment in its STRIDE pivotal trial evaluating the investigational eShunt System in patients with normal pressure hydrocephalus (NPH).

With patient enrollment complete at 32 clinical sites, STRIDE is progressing through remaining treatment and follow-up activities for consented patients, keeping the company on track toward topline data and continued progress through the U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) process.

“Reaching full enrollment is an important achievement for STRIDE and reflects the clinical community’s commitment to studying less invasive treatment options for patients with NPH,” said Charles Matouk, M.D., of Yale Neurosurgery. “The study will continue to follow its protocol as previously consented patients complete the remaining clinical steps.”

STRIDE is a prospective, multicenter, randomized, controlled trial comparing the eShunt System head-to-head against the current care standard—the VP shunt—in elderly NPH patients. The results will serve as the clinical basis for CereVasc’s anticipated PMA submission to the FDA. The investigational eShunt System is the only endovascular shunt in clinical use and the first new treatment option developed for NPH since the standard of care was introduced more than 60 years ago, according to the company.

NPH is a serious, often under-recognized form of communicating hydrocephalus that affects an estimated 800,000 U.S. residents, causing progressive gait disturbance, cognitive decline, and urinary incontinence. The current standard of care treatment is brain surgery to place a conventional shunt. Some older patients, particularly those with comorbidities, may not be considered suitable candidates for conventional shunt surgery, potentially leaving them untreated.

“Completing patient enrollment 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,” CereVasc Chairman/CEO Dan Levangie stated. ”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.”

Located in Massachusetts’ healthcare hub, CereVasc Inc. is a clinical-stage medical device company developing minimally invasive treatments for neurological diseases. Its initial product, the eShunt System, employs a percutaneous transvenous-transdural approach to the central nervous system and is intended to enable the first minimally invasive treatment for communicating hydrocephalus (CH). The patented eShunt System includes an endovascularly implantable cerebrospinal fluid shunt and delivery components designed to treat CH without invasive surgery. The eShunt System is an investigational device and has not been approved by the FDA or any other regulatory agency for commercial sale.