Cerevasc has today reported initial results from its pilot US Food and Drug Administration (FDA)-approved investigational device exemption (IDE) clinical study of the eShunt system in the treatment of elderly patients with normal-pressure hydrocephalus (NPH).
This prospective, non-randomised, open-label, multicentre study is being conducted at 11 academic medical centres in the USA, and is enrolling patients with NPH for whom a traditional cerebrospinal fluid (CSF) shunt implant is indicated. The objective of the study is to evaluate the safety and efficacy of the eShunt procedure.
Cerevasc has reported results in 30 elderly patients treated with its eShunt system in the USA, relaying that the study’s primary safety and primary efficacy endpoints were both achieved.
As per the 90-day primary endpoint, no (0%) serious adverse events related to the study device or procedure, and no (0%) unanticipated adverse device effects, were reported. Additionally, 97% of treated patients (29/30) demonstrated improvements in their clinical symptoms of NPH—which included gait improvement, measured by the timed up and go (TUG) test; cognitive improvement, measured by the Montreal cognitive assessment (MoCA); and improvement in urinary symptoms, measured by the neurogenic bladder symptom score (NBSS).
“The results of this study show that an endovascular approach to treating NPH may improve overall care and clinical outcomes,” said Charles Matouk (Yale New Haven Health, New Haven, USA). “A minimally invasive approach will allow us to make treatment available to more patients.”
Cerevasc relays that, in the study, no serious adverse events were reported in the first 90 days, while the average length of hospital stay was 1.3 days. The company goes on to note that published data on conventional open surgical shunt procedures for NPH have documented a 25.15% rate of complications or hospital readmission within 30 days of ventricular shunting, with the same review also finding an average hospital stay length of three days.
“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 and chief executive officer (CEO) of Cerevasc. “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.”
