CereVasc Marks eShunt System Study Milestone

The 100th patient has been treated with CereVasc Inc.’s hydrocephalus treatment device, the eShunt System. The 100 patients were enrolled in pilot studies and in the STRIDE clinical trial, a head-to-head comparison of the eShunt System versus the standard of care ventriculo-peritoneal (VP) shunt in patients with Normal Pressure Hydrocephalus (NPH).

The 100th patient was treated by Pedro Lylyk, M.D., at Clinica la Sagrada Familia in Buenos Aires, Argentina. Dr. Lylyk also treated the first eShunt System patient.

“I am honored to have performed the 100th procedure utilizing the eShunt System for patients with communicating hydrocephalus,” said Dr. Lylyk, CEO of ENERI and Clinica la Sagrada Familia in Buenos Aires and co-lead STRIDE trial investigator. “The minimally invasive procedure will help ensure more patients with hydrocephalus are eligible for treatment.”

The eShunt System is touted as the first and only minimally invasive, endovascular shunt and the first new treatment option developed for communicating hydrocephalus since the VP shunt was introduced more than 60 years ago. The STRIDE trial results will serve as the basis for CereVasc’s anticipated submission to regulatory agencies for approval to market the eShunt System.

“Reaching this milestone was made possible through the support of clinical investigators like Dr. Lylyk, who have demonstrated their commitment to driving innovation and improving patient care,” CereVasc Chairman/CEO Dan Levangie stated. “We are incredibly fortunate to work with Dr. Lylyk and his outstanding team in Buenos Aires and are excited by the enthusiastic response of the medical community for the eShunt System. Enrollment in our STRIDE pivotal trial is off to a strong start and we look forward to completing this landmark clinical study.”

Normal pressure hydrocephalus (NPH) is most commonly seen in adults aged 60 or over. The Hydrocephalus Association estimates that 800,000 older Americans may be living with NPH, and it is estimated that more than 80% of cases remain unrecognized or untreated. Without appropriate diagnostic testing, NPH is often misdiagnosed as Alzheimer’s disease or Parkinson’s disease, the result of a stroke, or other neurodegenerative conditions. Sometimes the symptoms are mistakenly attributed to “normal aging.” NPH is, however, one of the few treatable forms of dementia.

Located in Massachusetts’ healthcare hub, CereVasc is a clinical stage medical device company developing minimally invasive treatments for patients with neurological diseases. Its initial product, the eShunt System, encompasses percutaneous transvenous-transdural access to the central nervous system intended to enable the first minimally invasive treatment for communicating hydrocephalus (CH). The eShunt device 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 cerebral spinal fluid shunt and delivery components, which are designed to treat CH without invasive surgery.

The eShunt Device is an investigational device and has not been approved by any regulatory agency for commercial sale.