BOSTON— CereVasc, Inc., a clinical-stage, medical device company developing novel treatments for neurological diseases, announced today that it has received approval from the US Food and Drug Administration (FDA) to initiate its “Pivotal Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus” (STRIDE trial).
The IDE approval allows the Company to commence its groundbreaking STRIDE pivotal study comparing the safety and efficacy of its novel eShunt System for the treatment of patients with Normal Pressure Hydrocephalus to treatment with the current standard of care, the ventriculo-peritoneal (VP) shunt.
Charles Matouk, MD, Chief, Neurovascular Surgery, at Yale New Haven Health, will serve as Principal Investigator of the STRIDE study. “I am thrilled to participate in and lead the STRIDE study. Our experience with the eShunt System in pilot clinical studies has been extremely encouraging and I believe the STRIDE study has the potential to provide us the information we need to begin more widespread use of the eShunt System,” said Dr. Matouk.
“FDA approval of the STRIDE study is a significant milestone for CereVasc. The team has worked tirelessly to develop the eShunt System and we believe STRIDE will result in clinical data to support the use of our system in the treatment of patients with Normal Pressure Hydrocephalus (NPH),” said Dan Levangie, CereVasc Chairman & CEO. “We believe there is a significant unmet need in the treatment of NPH, and we are grateful for the work of our clinician collaborators, advisors and partners to develop this protocol,” he continued.
