CereVasc, Inc. announced today that the U.S. 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 hemorrhage (paSAH).
| US Based Pilot Study to enroll patients who develop communicating hydrocephalus following subarachnoid hemorrhage BOSTON, Aug. 9, 2022 /PRNewswire/ -- CereVasc, LLC, a privately held, clinical-stage, medical device company developing novel, minimally invasive treatments for neurological diseases, announced today that the U.S. 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 hemorrhage (paSAH).
“We are excited to receive IDE approval from FDA to conduct a second pilot study in the US 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 (NPH), 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,” said Dan Levangie, Chairman and CEO of CereVasc. “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,” continued Levangie. “Considering the encouraging results from our first-in-human 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 US,” said Adel Malek, MD, PhD, Neurosurgeon and Chief of Neurovascular Surgery at Tufts Medical Center, Boston. Details on the trial will soon be posted to www.clinicaltrials.gov. About CereVasc, Inc. Located in Massachusetts’ healthcare hub, CereVasc, Inc., is a clinical-stage, venture-funded, medical device company focused on the development of novel, minimally invasive treatments for patients with neurological diseases. Its flagship product, the eShunt System, is intended to offer the first minimally invasive treatment for communicating hydrocephalus (CH) and an improvement to the current standard of care. The eShunt device concept originated from Tufts Medical Center physicians Carl Heilman, MD, Neurosurgeon-in-Chief and Chairman of Neurosurgery, and Adel Malek, MD, PhD, Neurosurgeon and Chief of Neurovascular Surgery. The patented eShunt System includes an endovascularly implantable cerebral spinal fluid (CSF) shunt and delivery components, which are designed to treat CH without invasive surgery. For additional information, please visit our website at www.cerevasc.com. The eShunt® Device is an investigational device and not available for sale within or outside the United States. Company Contact
SOURCE CereVasc, Inc. |
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