CereVasc’s eShunt Device Evaluated in FIH Trial for Endovascular Treatment of Communicating Hydrocephalus

December 7, 2021—CereVasc, Inc. announced the publication of a case report detailing the first-in-human (FIH) treatment in a study of the company’s eShunt system, an investigational device intended to treat communicating hydrocephalus (CH).

According to the company, the eShunt device is a minimally invasive treatment for CH that offers the potential to result in significant benefits over the current neurosurgical treatment, which is associated with frequent failure, infection risk, and high costs. The eShunt system includes an endovascularly implantable cerebral spinal fluid shunt and CereVasc’s delivery components, which are designed to treat CH without invasive surgery, extended hospitalization, postprocedure pain management, and the risk of infection. The eShunt device is an investigational device and is not available for sale within or outside the United States, advised CereVasc.

The ongoing FIH clinical trial, ETCHES I (Endovascular Treatment of Communicating Hydrocephalus with the eShunt System), is being conducted by Pedro Lylyk, MD, at Clinica la Sagrada Familia in Buenos Aires, Argentina.

The case report, “First-in-human endovascular treatment of hydrocephalus with a miniature biomimetic transdural shunt,” was published online ahead of print by Dr. Lylyk et al in the Journal of NeuroInterventional Surgery (JNIS). The company noted that additional study data will be available in 2022.

Inventor and CereVasc cofounder Adel Malek, MD, who is Chief of Neurovascular Surgery at Tufts Medical Center in Boston, Massachusetts, commented on the milestone in the company’s press release.

“We are very pleased to have JNIS publish the first patient case report,” stated Dr. Malek. “The details and outcome of this case are encouraging signs about the potential of the eShunt system to address a common neurological condition with a long history of poor treatment options.”

CereVasc’s Chairman and Chief Executive Officer, Dan Levangie, added, “Despite this being very early data, there is great significance in the first ever treatment of hydrocephalus using a minimally invasive approach.”