BOSTON, June 23, 2026
CereVasc, Inc. has completed patient enrollment in its pivotal STRIDE clinical trial, marking a major milestone in the development of the investigational eShunt® System for the treatment of Normal Pressure Hydrocephalus (NPH). The study enrolled patients across 32 clinical sites in the United States, Canada, and Argentina, making STRIDE the largest randomized, controlled trial to compare a minimally invasive endovascular alternative with the conventional ventriculo-peritoneal (VP) shunt, the current standard treatment that has remained largely unchanged for more than 60 years. Completion of enrollment keeps CereVasc on schedule to complete patient follow-up, generate topline clinical data, and advance toward a planned U.S. FDA Premarket Approval (PMA) submission. The achievement represents one of the company’s most significant milestones as it works to introduce a next-generation medical device designed to improve the treatment of communicating hydrocephalus.
eShunt System Offers a Less Invasive Alternative for NPH Patients
The investigational eShunt System is the only endovascular shunt currently in clinical evaluation and has been developed to provide the first minimally invasive treatment option for communicating hydrocephalus. Unlike conventional VP shunt surgery, which requires an invasive neurosurgical procedure, the eShunt System utilizes a percutaneous transvenous-transdural approach to implant a cerebrospinal fluid shunt through the vascular system. Normal Pressure Hydrocephalus affects an estimated 800,000 people in the United States, causing progressive gait disturbances, cognitive decline, and urinary incontinence, particularly among older adults. Many elderly patients with additional health conditions are not considered ideal candidates for traditional surgery, creating a significant unmet medical need. By reducing surgical invasiveness while maintaining therapeutic effectiveness, the eShunt System has the potential to expand treatment access and improve outcomes for patients who currently have limited options
Clinical Progress Positions CereVasc for FDA Premarket Approval
With enrollment completed, CereVasc will continue treating patients who were already consented before enrollment closed while completing all remaining follow-up activities according to the study protocol. The company expects treatment procedures to conclude by the end of July 2026, after which investigators will evaluate the trial’s primary safety and effectiveness endpoints before announcing topline results. According to Dan Levangie, Chairman and Chief Executive Officer of CereVasc, reaching full enrollment is the company’s most important clinical achievement to date and reflects the dedication of investigators, healthcare professionals, patients, and employees supporting the program. Charles Matouk, MD, of Yale Neurosurgery, noted that successful enrollment demonstrates the medical community’s growing interest in evaluating innovative, less invasive technologies that could transform the management of Normal Pressure Hydrocephalus.
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Medical Device Innovation Could Reshape Hydrocephalus Treatment
The successful completion of enrollment in the STRIDE pivotal trial strengthens CereVasc’s position in the rapidly evolving MedTech sector and brings the eShunt System closer to becoming a commercially available treatment. If the trial meets its primary endpoints and receives FDA Premarket Approval, the device could become the first new treatment approach for Normal Pressure Hydrocephalus in more than six decades and the first endovascular shunt technology approved for clinical use. The innovation has the potential to redefine the standard of care by offering physicians a safer, minimally invasive alternative to conventional brain surgery while improving treatment accessibility for elderly patients. As demand grows for technologies that reduce procedural risks and recovery time, the eShunt System could represent a major advancement in neurosurgical medical devices, positioning CereVasc as a key innovator in the future of neurological healthcare and minimally invasive medical technology.
Source: CereVasc press release
