CereVasc Begins Trial of eShunt System for Communicating Hydrocephalus

February 10, 2021—CereVasc, Inc. announced that the first patient has been treated in a study of the company’s eShunt system, an investigational device intended to treat communicating hydrocephalus (CH). Study data will be available in 2021.

According to the company, the eShunt system offers a minimally invasive treatment for CH. The eShunt is implanted through a leg vein using x-ray guidance. The device is designed to eliminate the need for a craniotomy, passage of a catheter through the white matter of the brain, and subcutaneous tunneling across the chest and abdomen for placement of a long outflow catheter into a second surgical incision in the abdomen. The result of the minimally invasive approach brings the potential to dramatically reduce infection risk and several other common causes of ventriculoperitoneal shunt failure.

The company advised that clinicians will be able to deploy the eShunt implant in approximately 1 hour, potentially supporting an outpatient, same-day surgery alternative to traditional neurosurgery. As a minimally invasive treatment for CH, the eShunt device offers the potential to result in significant benefits over current treatment, which is a more than 50-year-old neurosurgical procedure associated with frequent failure, infection risk, and high costs, stated the company.

Carl Heilman, MD, and Adel Malek, MD, are co-inventors of the eShunt system and cofounders of CereVasc. Dr. Heilman is Neurosurgeon-in-Chief at Tufts Medical Center in Boston, Massachusetts, and Chairman of its Department of Neurosurgery. Dr. Malek is Director of Cerebrovascular and Endovascular Surgery Division at Tufts Medical Center. Tufts Medical Center licensed the eShunt to CereVasc.

In the company’s announcement, Dr. Heilman stated, “For nearly 30 years, a groundswell of clinicians, patients, professional societies, and government agencies have advocated aggressively for improvements to cerebrospinal fluid (CSF) shunts. While attempts to address this call to action followed, CSF shunts continue to fail frequently, leading to unnecessary patient burdens and high costs.”

Dr. Malek added, “We believe the eShunt system represents an opportunity to transform the quality and effectiveness of treatment for communicating hydrocephalus through a minimally invasive endovascular approach. The eShunt could improve patient outcomes and quality of life while potentially decreasing the high costs and risks associated with existing treatment.”

Additionally, the company noted that the ETCHES I (Endovascular Treatment of Communicating Hydrocephalus with the eShunt System) trial is taking place at Clinica Sagrada Familia in Buenos Aires, Argentina under the direction of Principal Investigator Pedro Lylyk, MD.

Commenting on the study in the company’s announcement, Dr. Lylyk stated, “Taking part in such an important trial with a device that has the potential to bring meaningful innovation to a half-century-old standard of care is thrilling for the entire team at Clinica Sagrada Familia here in Buenos Aires. We believe patients will experience significant benefits with the eShunt System. We are pleased to have our first patient treated and look forward to continuing the trial and generating data that will support the ongoing clinical evaluation of the system.”

Dr. Lylyk is chair of Neurosurgery and Hemodynamics at the University of Buenos Aires; professor of the Department of Vascular Medicine at the University of El Salvador in San Salvador, El Salvador; and Professor of Endovascular Surgery at the University of Ciencias Empresariales in Buenos Aires.