CereVasc Receives FDA IDE Approval to Begin Initial Clinical Study of the eShunt® System for Patients with Normal Pressure Hydrocephalus
BOSTON, Feb. 8, 2022 /PRNewswire/ — CereVasc, Inc., 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 with normal pressure hydrocephalus (NPH).
“We are delighted the FDA has granted this IDE allowing CereVasc to commence an initial clinical study evaluating the use of the eShunt System in patients with NPH, a disorder estimated to affect more than 700,000 Americans. It’s an exciting and important milestone for CereVasc and we look forward to working closely with the study investigators to evaluate a new treatment option with the potential to benefit thousands of elderly hydrocephalus patients,” said Dan Levangie, Chairman and CEO of CereVasc.
Representing the first minimally invasive treatment for NPH, the eShunt device offers the potential to result in benefits over the current treatment, a half-century old neurosurgical procedure associated with frequent failure, infection risk and high costs.
“This is a very important stage in the ongoing development of this technology. We are committed to continuing the development of this alternative to conventional shunting for the thousands of patients suffering from disabling effects of NPH and other forms of adult hydrocephalus,” said Carl Heilman, MD, Neurosurgeon-in-Chief and Chairman of Neurosurgery at Tufts Medical Center, Boston.
“We are excited about innovative therapies and the possibility of a minimally invasive treatment option for the management of hydrocephalus. This important trial could potentially benefit so many elderly patients disabled by this common neurologic disorder,” said Diana Gray, President & CEO of the Hydrocephalus Association. “There is currently a great deal of interest in the diagnosis and management of NPH, with the expectation that the reported incidence of this condition will increase dramatically with the aging of the population,” she continued.
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 system includes an endovascularly implantable cerebral spinal fluid (CSF) shunt and CereVasc’s patented 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.