CereVasc Receives FDA IDE Approval to Expand its Clinical Study of Patients with Normal Pressure Hydrocephalus Utilizing the Generation 2 eShunt® System
BOSTON, Sept. 18, 2023 /PRNewswire/ — CereVasc, Inc., a clinical-stage, medical device company developing novel treatments for neurological diseases, announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) supplement to permit the expansion of the study of the eShunt System in patients with Normal Pressure Hydrocephalus (NPH) to additional study participants and clinical sites.
The IDE supplement approval also allows for use of the next generation eShunt System in the NPH study. The Gen2 eShunt System has been designed to simplify the device preparation process, enhance the overall ease of use of the system, while maintaining eShunt Implant performance.
“The early results we have seen in our pilot study of the eShunt System in treating patients with iNPH have been positive and we could not be more excited about the opportunity to have Generation 2 of the eShunt System evaluated in an expanded NPH pilot study in the US”, said Dan Levangie, CereVasc President & CEO. “Our development team has thoughtfully incorporated feedback from our study investigators and our collaborators, Pedro Lylyk, M.D., Carl Heilman, M.D., and Adel Malek, M.D., Ph.D. to improve the usability of the system without compromising functionality or patient safety and are looking forward to its use in the study,” 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 the first-ever, 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.