CereVasc today announced the first patient randomised to and treated with the eShunt system in its STRIDE clinical trial.
STRIDE, a head-to-head comparison, pits the novel eShunt system against the standard of care ventriculo-peritoneal (VP) shunt in patients with normal pressure hydrocephalus (NPH). Investigators treated the first patient at VCU Health in Richmond. The study has multiple site locations open across the U.S.
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CereVasc’s trial assesses the safety and efficacy of eShunt against the VP shunt in elderly patients with NPH. The company plans to use STRIDE trial results to support its anticipated premarket approval (PMA) submission to the FDA.
Boston-based CereVasc designed eShunt for treating NPH. eShunt offers a minimally invasive endovascular treatment option with potential benefits, CereVasc says. It includes an endovascularly implantable cerebral spinal fluid (CSF) shunt and delivery components. Those delivery components include a self-expanding nitinol anchor.
eShunt has FDA breakthrough device designation, which it picked up last August. CereVasc initiated a pilot study of its eShunt system under investigational device exemption (IDE) in August 2022. In September 2023, it picked up a separate IDE supplement for a study of the next-generation eShunt system. Last May, the company received the FDA’s go-ahead to begin its STRIDE pivotal study under IDE.
“As the first randomised controlled trial comparing a modern alternative with the standard-of-care treatment for NPH, this trial is an important step in evaluating the safety and effectiveness of the eShunt system,” said Dan Levangie, CereVasc chair and CEO. “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.”
