CereVasc Receives IDE Approval for United States Pilot Study of eShunt System to Treat Communicating Hydrocephalus paSAH

August 9, 2022—CereVasc, Inc. announced that the FDA has approved an investigational device exemption (IDE) application to initiate a pilot trial of the company’s eShunt system in patients who develop communicating hydrocephalus post aneurysmal subarachnoid hemorrhage (paSAH). Details on the trial will soon be posted to www.clinicaltrials.gov, advised the company.

Neurosurgeons Carl Heilman, MD, and Adel Malek, MD, of Tufts Medical Center in Boston, Massachusetts, are co-inventors of the eShunt system and cofounders of CereVasc. Tufts Medical Center licensed the eShunt to CereVasc.

In December 2021, CereVasc announced the publication of a case report detailing the first-in-human (FIH) treatment with the eShunt system in the ETCHES I (Endovascular Treatment of Communicating Hydrocephalus with the eShunt System) clinical trial. ETCHES I is being conducted by Pedro Lylyk, MD, at Clinica la Sagrada Familia in Buenos Aires, Argentina. The case report was published online by Dr. Lylyk et al in the Journal of NeuroInterventional Surgery.

“Considering the encouraging results from our FIH study of the eShunt system in Argentina in patients with hydrocephalus secondary to subarachnoid hemorrhage, we are eager to study the same patient population in the United States,” commented Dr. Malek in the company’s press release.

Dan Levangie, Chairman and CEO of CereVasc, stated in the press release, “We are excited to receive IDE approval from FDA to conduct a second pilot study in the United States of the eShunt system in patients who develop hydrocephalus following subarachnoid hemorrhage. Enrolling in parallel with our first IDE study in patients with normal pressure hydrocephalus, this study will allow us to further examine the safety and efficacy of the eShunt system in a second etiology of hydrocephalus, both of which present a number of management challenges to physicians.”

Mr. Levangie continued, “Reports in the literature document that chronic hydrocephalus occurs in 9% to 48% of patients with paSAH. We believe we can have a beneficial impact in how these patients are treated by offering a minimally invasive alternative to current treatments.”