CereVasc Announces First Patient Treated in U.S. Pilot Trial Evaluating the eShunt System in Patients with Normal Pressure Hydrocephalus
BOSTON, Aug. 29, 2022 /PRNewswire/ — CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel, minimally invasive treatments for neurological diseases, announced completion of the first eShunt® procedure in the United States. The study, ‘US Pilot Study of the CereVasc eShunt System in Normal Pressure Hydrocephalus (NPH)’, is being conducted under an investigational device exemption (IDE) approved by the US Food and Drug Administration (FDA) earlier this year.
The patient was treated at Yale Medicine by Dr. Charles Matouk, Associate Professor of Neurosurgery; Vice Chair of Clinical Affairs, Neurosurgery; Chief, Neurovascular Surgery; Director, Neurovascular/Endovascular Fellowship. “We are pleased to participate in this study of the eShunt System, a promising device with the potential to transform the care of patients with NPH using a minimally invasive approach as opposed to open surgery,” said Dr. Matouk.
“This study, which will evaluate the safety and efficacy of the eShunt System, represents a significant milestone for the company and the neurovascular field, as we advance our solution for the millions of people across the world that suffer from NPH through the clinical pathway,” said Dan Levangie, Chairman and CEO of CereVasc.
Details on the trial are available at https://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.