CereVasc Receives FDA IDE Approval for the STRIDE Pivotal Study of the eShunt System for Treatment of Normal Pressure Hydrocephalus
With this FDA IDE approval, CereVasc will initiate the STRIDE pivotal study.
BOSTON, May 7, 2024 /PRNewswire/ — 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.
About CereVasc, Inc.
Located in Massachusetts’ healthcare hub, CereVasc, Inc., is a clinical stage, medical device company focused on the development of novel, minimally invasive treatments for patients with neurological diseases. Its initial product, the eShunt System, encompasses first-ever, groundbreaking percutaneous transvenous-transdural access to the central nervous system intended to allow the first minimally invasive treatment for communicating hydrocephalus (CH), a potential improvement to the current standard of care. The eShunt device concept originated from Tufts Medical Center physicians Carl Heilman, MD, Neurosurgeon-in-Chief and Chair of Neurosurgery, and Adel Malek, MD, PhD, Chief of Neurovascular Surgery and Director of Endovascular Neurosurgery. The patented eShunt System includes an endovascularly implantable cerebral spinal fluid (CSF) shunt and delivery components, which are designed to treat CH without invasive surgery. For additional information, please visit our website at www.cerevasc.com.
The eShunt® Device is an investigational device and not available for sale within or outside the United States.
Company Contacts:
DJ Cass
CereVasc, Inc.
djcass@cerevasc.com