CereVasc Releases eShunt System Study Data

CereVasc Inc. is sharing encouraging results from a prospective, multi-center, single-arm clinical study evaluating the safety and clinical outcomes of its eShunt System in patients with normal pressure hydrocephalus (NPH).

Sixty-six patients were treated in the study at 12 sites in the United States and Argentina. Published in the Journal of NeuroInterventional Surgery (JNIS), key trial data through 90-day follow-up include:

• 0% rate of device-related serious adverse events (SAEs)
• 3% rate of procedure-related SAEs, all resolved without surgical intervention
• 95% of participants demonstrated improvement in at least one of the three primary clinical symptoms of NPH (gait disturbance, cognitive impairment, and urinary incontinence)
• Statistically significant improvement from baseline was documented in all three primary clinical symptoms of NPH
• Zero observations of symptomatic or radiologic cerebral hemorrhage or over-drainage, confirmed by blinded, independent core lab MR and CT image analysis
• No instances of infection related to the procedure or device

“The outcomes achieved in this study are highly encouraging. The favorable safety profile, along with statistically significant symptom improvements observed at the 90-day follow-up, provides an early clinical signal that supports continued evaluation of an endovascular approach for the treatment of NPH,” said Charles Matouk, M.D., vice chair of Clinical Affairs, Neurosurgery, and chief of Neurovascular Surgery at Yale School of Medicine.

The eShunt System is a minimally invasive endovascular shunt and the first new treatment option developed for communicating hydrocephalus since the VP shunt was introduced more than 60 years ago. The STRIDE pivotal trial is currently enrolling patients at 28 sites in the United States, Argentina, and Canada. The STRIDE trial is a prospective, multi-center, randomized study comparing the eShunt System to conventional ventriculoperitoneal shunting. 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.

“We believe the eShunt System represents a significant advancement in the treatment of NPH, and we are eager to further evaluate these results in the STRIDE randomized, controlled pivotal trial,” CereVasc Chairman/CEO Dan Levangie stated. “The STRIDE trial is the first head-to-head comparison of conventional shunting to the minimally invasive eShunt System, and with the data generated to date and enthusiasm from practitioners and patients, we remain focused on advancing this innovation toward a potential new standard of care for patients with NPH.”

Normal pressure hydrocephalus (NPH) is a neurologic disorder characterized by gait disturbance, cognitive impairment, and urinary incontinence, and is most seen in adults ages 60 or older. The Hydrocephalus Association estimates that 800,000 older Americans may be living with NPH, with more than 80% of cases unrecognized or untreated. Without appropriate diagnostic testing, NPH is often mistaken for Alzheimer’s disease or Parkinson’s disease, the result of a stroke, or other neurodegenerative conditions. Sometimes the symptoms are attributed to “normal aging.” NPH is, however, one of the few treatable forms of dementia.

“NPH remains challenging to diagnose and manage, and conventional shunting is associated with well-documented risks and variability in outcomes,” added Dr. Pedro Lylyk, M.D., CEO of ENERI and Clinica la Sagrada Familia. “These early results suggest that an endovascular approach may offer NPH symptom improvement while providing a treatment with potentially fewer complications and adverse events. This is an exciting milestone in advancing care for this patient population.”

Located in Massachusetts’ healthcare hub, CereVasc Inc., is a clinical-stage medical device company developing minimally invasive treatments for patients with neurological diseases. Its initial product, the eShunt System, employs a percutaneous transvenous-transdural access to the central nervous system intended to enable the first minimally invasive treatment for communicating hydrocephalus (CH). The eShunt system 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 cerebrospinal fluid shunt and delivery components, which are designed to treat CH without invasive surgery.

The eShunt System is an investigational device and has not been approved by any regulatory agency for commercial sale.