First Patient Randomized to eShunt System Treatment in CereVasc Study

The first patient has been randomized to and treated with CereVasc Inc.’s eShunt System in its multi-center, randomized, controlled STRIDE clinical trial, a head-to-head comparison of eShunt versus the standard of care shunt (ventriculo-peritoneal, or VP) in patients with normal pressure hydrocephalus (NPH). The patient was treated at VCU Health in Richmond.

Multiple STRIDE trial site locations are now open throughout the United States.

“Treatment of the first patient with the eShunt System in the STRIDE trial marks an important milestone for CereVasc by providing a potential new treatment option for patients with NPH and for the medical community, which has expressed considerable enthusiasm about the promise of the eShunt System,” CereVasc Chairman/CEO Dan Levangie said. “As the first randomized controlled trial comparing a modern alternative with the standard-of-care treatment for NPH, this trial is an important step in evaluating the safety and effectiveness of the eShunt System. This trial could provide a way for elderly patients with NPH to improve their quality of life while supporting an overall movement toward minimally invasive procedures across the field of neurosurgery.”

STRIDE trial results will serve as the basis for CereVasc’s anticipated Premarket Approval (PMA) submission to the U.S. Food and Drug Administration (FDA).

NPH is a life-threatening form of communicating hydrocephalus that affects 800,000 people in the United States alone.

“I was honored to perform the inaugural treatment in the STRIDE trial. This investigation could lead to a safer and less invasive way to address the gait disturbance, cognitive deficits, and urinary incontinence that are experienced by people with NPH,” said John Reavey-Cantwell, M.D., neurosurgeon and director of Cerebrovascular and Endovascular Neurosurgery at VCU Health. “Because the eShunt System is less invasive than the VP shunt, this trial will assess its potential to improve recovery times and reduce post-operative complications such as infection. As a result, I’m hopeful it will make treatment possible for more patients living with this devastating neurological disease—including those who have comorbidities.”

The eShunt System is the only endovascular shunt and the first new treatment option developed for NPH since the standard of care was introduced more than 60 years ago, according to the company.

Located in Massachusetts’ healthcare hub, CereVasc is a clinical stage medical device company developing minimally invasive treatments for patients with neurological diseases. Its initial product, the eShunt System, encompasses first-ever 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, M.D., neurosurgeon and Chair Emeritus of Neurosurgery, and Adel Malek, M.D., Ph.D., 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.

The eShunt Device is an investigational product and has not been approved by U.S. Food and Drug Administration or any other regulatory agency for commercial sale.