Studies generate encouraging results in advance of the STRIDE pivotal trial
BOSTON, Sept. 17, 2024 /PRNewswire/ -- CereVasc, Inc., a clinical-stage medical device company developing novel treatments for neurological diseases, today announced enrollment of the 50th patient in its pilot studies of the eShunt System in patients with Normal Pressure Hydrocephalus (NPH), in centers in the U.S. and in Argentina.
The studies, (NCT05232838 and NCT05250505) approved by the U.S. Food and Drug Administration (FDA) and by the National Administration of Drugs, Food and Medical Devices (ANMAT) in Argentina are being conducted under the leadership of Charles Matouk, MD, of Yale New Haven Health and Pedro Lylyk, MD, of Clinica la Sagrada Familia.
“We are thrilled to have achieved this milestone of enrolling 50 patients in our pilot studies of the eShunt System in patients with NPH and we are very thankful for the support we have received from our clinical investigators in achieving this level of study enrollment,” said Dan Levangie, Chairman & CEO of CereVasc, Inc.
A key next step in the development of the eShunt System will be the STRIDE pivotal study in patients with NPH. This multi-center, randomized controlled trial will assess the safety and efficacy of the eShunt System compared with the standard-of-care ventriculo-peritoneal (VP) shunt, serving as the basis for the company’s future Premarket Approval (PMA) submission to the FDA.
“The level of enthusiasm about the potential of the eShunt System from physicians, patients and caregivers we have seen throughout the pilot study provides tremendous momentum as we initiate the STRIDE trial,” continued Levangie.
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-in-Chief and Chair of Neurosurgery, and Adel Malek, MD, PhD, Chief of Neurovascular Surgery and Director of 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 not available for sale within or outside the United States.
Media and Company Contact:
Ethan Metelenis, Precision AQ
Ethan.Metelenis@precisionaq.com
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SOURCE CereVasc
