eShunt® System Receives FDA Breakthrough Device Designation
BOSTON, Aug. 28, 2024 /PRNewswire/ — CereVasc, Inc., a clinical-stage, medical device company developing novel treatments for neurological diseases, today announced it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its eShunt System, intended to treat Normal Pressure Hydrocephalus (NPH). The Breakthrough Device Designation was supported by data generated during pilot clinical studies of the device.
“Our team is thrilled to achieve this milestone and to have the eShunt System recognized by the FDA as a Breakthrough Device. The ability to collaborate with FDA under the Breakthrough Program will support our goal to bring an endovascular option to the treatment of patients with NPH,” said Dan Levangie, Chairman and CEO. “It is estimated that more than 700,000 individuals in the US suffer from NPH with the vast majority going untreated. Consequently, we have seen strong interest among patients, caregivers, and clinicians in an endovascular treatment option to address this significant health challenge,” he continued.
The designation will enable priority review and enhanced communication with FDA during the clinical trial and premarket review process. CereVasc was recently granted an Investigational Device Exemption (IDE) for its STRIDE pivotal study evaluating the eShunt System for the treatment of NPH, with enrollment on track to begin in the second half of 2024.
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 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