CereVasc Receives Approval for STRIDE Clinical Trial of the eShunt® System for the Treatment of Elderly Patients with Normal Pressure Hydrocephalus in Argentina
BOSTON, Feb. 13, 2025 /PRNewswire/ -- CereVasc, Inc., a clinical-stage medical device company developing novel treatments for neurological diseases, announced today that it has received approval from Argentina's National Administration of Drugs, Food and Medical Devices (ANMAT) to initiate the STRIDE trial, a clinical study evaluating CereVasc's eShunt System as a treatment for normal pressure hydrocephalus (NPH).
The trial will evaluate the safety and effectiveness of the eShunt System versus the current standard of care, the ventriculo-peritoneal (VP) shunt, in draining accumulated cerebrospinal fluid from the brain in elderly patients. The results of the STRIDE trial will serve as the basis for CereVasc's anticipated submission to regulatory agencies for approval to market the eShunt System.
"Treatment is essential for patients with NPH, as this progressive, life-threatening form of communicating hydrocephalus can cause symptoms including cognitive dysfunction, gait disturbance and urinary incontinence," said Pedro Lylyk, M.D., CEO of ENERI and Clinica la Sagrada Familia in Buenos Aires and co-lead investigator of the STRIDE trial. "Positive findings from the STRIDE trial will broaden access to NPH treatment in Argentina, as more patients would likely be eligible for a minimally invasive procedure than for open brain surgery."
The eShunt System is the only minimally invasive, endovascular shunt and the first new treatment option developed for NPH since the VP shunt was introduced more than 60 years ago.
"We're pleased that ANMAT has approved this study, enabling us to move closer to a new standard in NPH treatment designed to reduce recovery time and complications for patients," said Dan Levangie, Chairman and CEO of CereVasc. "The launch of the STRIDE trial in Argentina represents a key milestone in CereVasc's mission to improve the quality of life for people around the world who are affected by this devastating neurological condition."
For more information, please visit https://nphstridestudy.com/.
About CereVasc, Inc.Located in Massachusetts' healthcare hub, CereVasc, Inc., is a clinical stage, medical device company focused on the development of novel, minimally invasive treatments for patients with neurological diseases. Its initial product, the eShunt System, encompasses first-ever, groundbreaking percutaneous transvenous-transdural access to the central nervous system intended to allow the first minimally invasive treatment for communicating hydrocephalus (CH). The eShunt device concept originated from Tufts Medical Center physicians Carl Heilman, MD, Neurosurgeon and Chair Emeritus of Neurosurgery, and Adel Malek, MD, PhD, Chief of Neurovascular Surgery and Director of Cerebrovascular and Endovascular Neurosurgery. The patented eShunt System includes an endovascularly implantable cerebral spinal fluid 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 has not been approved by FDA or any other regulatory agency for commercial sale. Its safety and effectiveness have not yet been fully established.
Company Contacts: DJ CassCereVasc, Inc.djcass@cerevasc.com
Media Contacts: Ethan MetelenisPrecision AQEthan.Metelenis@precisionaq.com
Christina RenfroePrecision AQChristina.Renfroe@precisionaq.com
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SOURCE CereVasc
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