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February 26, 2026
CereVasc eShunt System Studied in Treatment of Patients with NPH
KEY TAKEAWAYS
- CereVasc’s eShunt system was evaluated in patients with normal pressure hydrocephalus
- 90-day follow-up showed improvement in primary clinical symptoms of NPH with no device-related SAEs
February 26, 2026—CereVasc, Inc. announced results from a prospective, multicenter, single-arm clinical study evaluating the safety and clinical outcomes of the eShunt system in patients with normal pressure hydrocephalus (NPH). The study was composed of 66 patients treated at 12 sites in the United States and Argentina.
The pilot study results were published by Pedro Lylyk, MD, and Charles Matouk, MD, et al in Journal of NeuroInterventional Surgery.
As outlined in CereVasc’s press release, key results 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 patients 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 in all three primary clinical symptoms of NPH
- No symptomatic or radiologic cerebral hemorrhage or over-drainage
- No procedure- or device-related infections
“The outcomes achieved in this study are highly encouraging,” commented Dr. Matouk in the company’s press release. “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.”
Dr. Lylyk added, “NPH remains challenging to diagnose and manage, and conventional shunting is associated with well-documented risks and variability in outcomes. 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.”
CereVasc advised that the eShunt system is an investigational device and has not been approved by any regulatory agency. The STRIDE pivotal trial, which will be the basis for the company’s anticipated submission to regulatory agencies for approval to market the device, is enrolling patients at 28 sites in the United States, Argentina, and Canada.
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