CereVasc today announced the first-in-human case report for the use of its eShunt system to treat medically refractory idiopathic intracranial hypertension (IIH).
IIH, formerly known as pseudotumor cerebri, is characterized by elevated pressure around the brain without an identifiable structural cause. The condition is associated with chronic headaches, nausea, tinnitus, papilledema, visual disturbances, and risk of progressive vision loss.
Boston-based CereVasc designed eShunt as a minimally invasive endovascular treatment option with potential benefits. It includes an endovascularly implantable cerebral spinal fluid (CSF) shunt and delivery components. Those delivery components include a self-expanding nitinol anchor.
The company also targets treating normal pressure hydrocephalus (NPH) with eShunt, recently reporting “encouraging” results. Its new target area includes the first human use in a patient whose IIH symptoms persist despite medical therapy. Dr. Pedro Lylyk and colleagues at ENERI Medical Institute in Buenos Aires, Argentina, led the cases. They published their findings in Stroke: Vascular and Interventional Neurology.
CereVasc said that, at 35 days, the patient reported improvement in headaches, diplopia and overall quality of life. Investigators also saw reduced CSF opening pressure compared to pre-treatment baseline. MRI showed decreased optic nerve sheath distension compared to baseline as well.
At five months, the patient reported persistent symptom improvement. Investigators reported the ability to continue acetazolamide and nonsteroidal anti-inflammatory medications. Imaging also demonstrated maintained device patency.
CereVasc said three-year follow up saw continued, sustained CSF drainage with eShunt and sustained improvement in headaches and visual symptoms. Investigators reported no device- or procedure-related complications. Those include over-drainage, thrombosis, stroke, occlusion, displacement and subdural collections.
Commentary from investigators and company officials
Lylyk, CEO of ENERI Medical Institute and Clinica la Sagrada Familia and lead author of the case report, said:
“The eShunt System offers a novel, minimally invasive endovascular approach that successfully reduced intracranial pressure, alleviated optic nerve edema, and provided sustained symptomatic relief in this medically refractory IIH patient, with device patency maintained through three years of follow-up.”
Dan Levangie, chair and CEO of CereVasc, added:
“This first-in-human experience of the eShunt System in idiopathic intracranial hypertension highlights the potential of our minimally invasive technology to expand treatment options for patients living with elevated intracranial pressure. By emulating natural CSF drainage pathways without open surgery, the eShunt System is designed to address limitations of current therapies and supports our ongoing commitment to advancing solutions that improve patient outcomes and quality of life.”
