CereVasc announced today that the US Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to initiate a pilot trial of the eShunt system in patients who develop communicating hydrocephalus post-aneurysmal subarachnoid haemorrhage (paSAH).
“Considering the encouraging results from our first-in-human study of the eShunt system in Argentina in patients with hydrocephalus secondary to subarachnoid haemorrhage, we are eager to study the same patient population in the USA,” said Adel Malek (Tufts Medical Center, Boston, USA).
“We are excited to receive IDE approval from FDA to conduct a second pilot study in the USA of the eShunt System in patients who develop hydrocephalus following subarachnoid haemorrhage,” added CereVasc chairman and CEO Dan Levangie. “Enrolling in parallel with our first IDE study in patients with normal-pressure hydrocephalus (NPH), this study will allow us to further examine the safety and efficacy of the eShunt system in a second aetiology of hydrocephalus—both of which present a number of management challenges to physicians.
“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.”