CereVasc today announced initial results from a pilot clinical study supporting the use of its eShunt system.
Boston-based CereVasc designed eShunt for treating normal pressure hydrocephalus (NPH). This study evaluates the technology in the treatment of elderly patients with NPH. eShunt has FDA breakthrough device designation, which it picked up last August.
eShunt offers a minimally invasive endovascular treatment option with potential benefits compared to the current gold-standard treatment. It includes an endovascularly implantable cerebral spinal fluid (CSF) shunt and delivery components, featuring a self-expanding nitinol anchor.
CereVasc initiated a pilot study of its eShunt system under investigational device exemption (IDE) in August 2022. In September 2023, it picked up a separate IDE supplement for a study of the next-generation eShunt system. Last May, the company received the FDA’s go-ahead to begin its STRIDE pivotal study under IDE. It also completed the initial closing of a Series B round worth $70 million a few months ago.
A look at the data from CereVasc
The IDE study, evaluating eShunt’s safety and efficacy, takes place across 11 academic medical centers in the U.S. It evaluates subjects with NPH indicated for a traditional CSF shunt implant.
CereVasc reported results from 30 patients treated with eShunt, outlining the achievement of both the primary safety and efficacy endpoints. The company said 97% of subjects (29/30) experienced improvement in clinical NPH symptoms. Average hospital length stay came in at 1.3 days. The study had zero serious adverse events related to the study device or procedure in the first 90 days. CereVasc also reported zero unanticipated adverse device effects.
The company says conventional open surgical shunt procedures for NPH have documented a 25.15% rate of complications or hospital readmission within 30 days of ventricular shunting. That review also documented an average hospital stay length of three days.
Investigators reported improved gait and cognitive improvement along with better urinary symptoms, all clinical NPH symptoms. Dr. Charles Matouk, chief of neurovascular surgery at Yale New Haven Health, said the results demonstrate that an endovascular approach to treating NPH “may improve overall care and clinical outcomes.”
“We are tremendously encouraged by these outstanding preliminary safety and efficacy results and to observe the record of rapid recovery and abbreviated length of hospital stay experienced by the subjects treated with the eShunt System,” said Dan Levangie, Chairman & CEO of CereVasc, Inc. “We are encouraged by the absence of Serious Adverse Events at 90 days combined with clinical improvement in nearly every patient, which supports our belief that an endovascular, minimally invasive treatment approach could provide significant safety and efficacy benefits, allowing a greater number of patients with this neurodegenerative disorder to receive treatment.”
