In a significant advancement for neurosurgical treatment, CereVasc, Inc. has announced the successful treatment of the first patient with their innovative eShunt® System as part of the STRIDE pivotal trial. The procedure, performed at VCU Health in Richmond, marks the beginning of a head-to-head comparison between this novel minimally invasive approach and traditional ventriculo-peritoneal (VP) shunts for normal pressure hydrocephalus (NPH).
The STRIDE trial represents a crucial step forward in addressing NPH, a life-threatening form of communicating hydrocephalus that affects approximately 800,000 people in the United States. This multi-center, randomized, controlled study will evaluate both the safety and efficacy of the eShunt System compared to current standard VP shunt treatment.
Revolutionary Approach to NPH Treatment
The eShunt System stands out as the first endovascular shunt developed for NPH treatment, offering a less invasive alternative to the traditional surgical approach that has remained unchanged for more than six decades. This innovative device is designed to address the characteristic symptoms of NPH, including gait disturbance, cognitive deficits, and urinary incontinence.
Dr. John Reavey-Cantwell, Neurosurgeon and Director of Cerebrovascular and Endovascular Neurosurgery at VCU Health, who performed the inaugural procedure, expressed optimism about the trial's potential impact. "Because the eShunt System is less invasive than the VP shunt, this trial will assess its potential to improve recovery times and reduce post-operative complications such as infection," he stated. "I'm hopeful it will make treatment possible for more patients living with this devastating neurological disease — including those who have comorbidities."
Clinical Trial Design and Objectives
The STRIDE trial is being conducted across multiple U.S. locations, with results intended to support CereVasc's upcoming Premarket Approval (PMA) submission to the FDA. The study's design focuses on elderly patients diagnosed with NPH, comparing outcomes between the novel eShunt System and traditional VP shunt procedures.
Dan Levangie, CereVasc's Chairman & CEO, highlighted the significance of this milestone: "This trial is an important step in evaluating the safety and effectiveness of the eShunt System. This trial could provide a way for elderly patients with NPH to improve their quality of life while supporting an overall movement toward minimally invasive procedures across the field of neurosurgery."
Technology Development and Origins
The eShunt device concept originated from Tufts Medical Center physicians, including Dr. Carl Heilman, Neurosurgeon and Chair Emeritus of Neurosurgery, and Dr. Adel Malek, Chief of Neurovascular Surgery. The system utilizes a groundbreaking percutaneous transvenous-transdural access approach to the central nervous system, potentially revolutionizing the treatment of communicating hydrocephalus.
While the eShunt System shows promise, it remains an investigational device pending FDA approval, with its safety and effectiveness still under evaluation through the STRIDE trial. The medical community has expressed considerable enthusiasm about its potential to transform NPH treatment, particularly for patients who may not be candidates for traditional surgical approaches.
