CereVasc announced today that it completed patient enrollment in the STRIDE pivotal trial evaluating its investigational eShunt system.
Boston-based CereVasc said it completed enrollment at 32 clinical sites. Now, STRIDE continues to progress through remaining treatment and follow-up activities for consented patients. The company said it is on track for topline data and continued progress through the FDA premarket approval (PMA) process.
eShunt is a minimally invasive endovascular treatment option with potential benefits. It includes an endovascularly implantable cerebral spinal fluid (CSF) shunt and delivery components. Those delivery components include a self-expanding nitinol anchor. The company recently closed an $85 million Series E round to support the system.
STRIDE evaluates eShunt in patients with normal pressure hydrocephalus (NPH). The study pits it head-to-head with the current standard of care, the VP shunt. CereVasc labels eShunt the only endovascular shunt in clinical use. It also represents the first new treatment option developed for NPH since the standard of care’s introduction 60 years ago, the company says.
“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,” said Dan Levangie, chair and CEO of CereVasc. “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.”
