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CereVasc Completes Enrollment in Pivotal eShunt Trial for NPH

After more than 60 years of relying on traditional brain surgery, the treatment landscape for normal pressure hydrocephalus may be shifting. CereVasc, Inc. has officially closed patient enrollment for its STRIDE pivotal trial, marking a significant step toward securing FDA approval for its minimally invasive eShunt System.

CereVasc Completes Enrollment in Pivotal eShunt Trial for NPH
Photo: Bio & News

The STRIDE trial, which spans 32 clinical sites across the United States, Canada, and Argentina, serves as a head-to-head comparison between the investigational eShunt System and the standard ventriculo-peritoneal shunt. By utilizing a percutaneous transvenous-transdural approach, the device aims to provide a viable alternative for elderly patients whose comorbidities often disqualify them from undergoing conventional neurosurgery.

Normal pressure hydrocephalus affects approximately 800,000 Americans, manifesting through cognitive decline, gait disturbances, and urinary incontinence. According to Dan Levangie, CEO of CereVasc, the completion of enrollment represents the most significant clinical milestone in the company's history. While the trial has reached its recruitment target, investigators will continue to monitor consented patients through their remaining treatment and follow-up phases, with topline data expected to form the foundation of an upcoming Premarket Approval submission to the FDA.

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