CereVasc’s eShunt System Performs Well in First Idiopathic Intracranial Hypertension Case

CereVasc Inc. is sharing a first-in-human case report describing the use of its eShunt System to treat medically refractory idiopathic intracranial hypertension (IIH), formerly known as pseudotumor cerebri. Published in Stroke: Vascular and Interventional Neurology, the report details treatment with the eShunt System in a patient whose symptoms persisted despite medical therapy.

Led by Pedro Lylyk, M.D., and colleagues at ENERI Medical Institute in Buenos Aires, Argentina, the case involved a 50-year-old man with a history of chronic IIH whose symptoms had progressed despite treatment with acetazolamide and serial lumbar punctures. Following regulatory and ethics approval for compassionate use, the patient underwent minimally invasive endovascular treatment with the eShunt System.

“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,” CereVasc Chairman/CEO Dan Levangie said. “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.”

Case Summary:

• 35-day follow-up
  • The patient reported improvement in headaches, diplopia, and overall quality of life
  • Reduced cerebrospinal fluid (CSF) opening pressure compared to pre-treatment baseline opening pressure
  • Magnetic resonance imaging (MRI) showed decreased optic nerve sheath distension compared to baseline MRI, and gadolinium-enhanced cisternography confirmed CSF flow through the implant into the internal jugular vein
    
• FIve-month follow-up
  • The patient reported persistent symptom improvement
  • Ability to discontinue acetazolamide and nonsteroidal anti-inflammatory medications
  • Imaging demonstrated maintained device patency
    
• Three-year follow-up
  • MRI continued to demonstrate a patent eShunt Implant with sustained CSF drainage
  • The patient reported sustained improvement of headaches and visual symptoms
  • No device- or procedure-related complications, including over drainage, thrombosis, stroke, occlusion, displacement, or subdural collections were observed during follow-up

“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,” stated Dr. Lylyk, CEO of ENERI Medical Institute and Clinica la Sagrada Familia and lead report author.

Idiopathic Intracranial Hypertension (IIH) 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. IIH affects approximately one to two individuals per 100,000 annually in the general population, with substantially higher incidence among women of childbearing age and obese people. Current treatment options include medication, repeat lumbar punctures, venous sinus stenting, or ventriculoperitoneal (VP) shunting, each with associated risks and limitations.

Located in Massachusetts’ healthcare hub, CereVasc Inc., is a clinical-stage medical device company developing minimally invasive treatments for patients with neurological diseases. Its initial product, the eShunt System, employs an innovative percutaneous transvenous-transdural access to the central nervous system to enable the first minimally invasive treatment for communicating hydrocephalus (CH). The eShunt system concept originated from Tufts Medical Center physicians Carl Heilman, M.D., neurosurgeon and Chair Emeritus of Neurosurgery, and Adel Malek, M.D., Ph.D., chief of Neurovascular Surgery and director of Cerebrovascular and Endovascular Neurosurgery. The patented eShunt System includes an endovascularly implantable cerebrospinal fluid shunt and delivery components, which are designed to treat CH without invasive surgery.

The eShunt System is an investigational device and has not been approved by the U.S. Food and Drug Administration or any other regulatory agency for commercial sale. Its safety and effectiveness have not yet been fully established.