CereVasc’s eShunt for Hydrocephalus Earns FDA Breakthrough Nod

CereVasc has earned breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its eShunt system to treat normal pressure hydrocephalus (NPH).
 
This designation was backed by data gathered during pilot clinical studies of the eShunt system. The company was also awarded Investigational Device Exemption (IDE) for its STRIDE pivotal study evaluating eShunt for NPH and enrollment is expected to begin in the second half of 2024.
 
“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, CereVasc’s 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 eShunt system is a percutaneous transvenous-transdural access device for the central nervous system. It is a minimally invasive treatment for communicating hydrocephalus (CH) and potential improvement to the current standard of care.
 
The device includes an endovascularly implantable cerebral spinal fluid shunt and delivery components. 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.