Cerevasc has announced that the first patient has been randomised to and treated with the eShunt system in its STRIDE clinical trial—a head-to-head comparison of this novel system versus the standard-of-care ventriculoperitoneal (VP) shunt in patients with normal-pressure hydrocephalus (NPH). The patient was treated at Virginia Commonwealth University (VCU) Health in Richmond, USA.
Multiple trial site locations are now open across the USA, as per a recent press release from Cerevasc.
STRIDE is a multicentre randomised controlled trial designed to assess the safety and efficacy of the eShunt system compared with the current standard of care, the VP shunt, in elderly patients diagnosed with NPH. The results of the STRIDE trial will serve as the basis for Cerevasc’s anticipated premarket approval (PMA) submission to the US Food and Drug Administration (FDA).
“I was honoured to perform the inaugural treatment in the STRIDE trial. This investigation could lead to a safer and less invasive way to address the gait disturbance, cognitive deficits, and urinary incontinence, that are experienced by people with NPH,” said John Reavey-Cantwell (VCU Health, Richmond, USA). “Because the eShunt system is less invasive than the VP shunt, this trial will assess its potential to improve recovery times and reduce postoperative complications, such as infection. As a result, I’m hopeful it will make treatment possible for more patients living with this devastating neurological disease—including those who have comorbidities.”
Cerevasc claims that the eShunt system is the only endovascular shunt and the first new treatment option developed for NPH since the standard of care was introduced more than 60 years ago.
“The treatment of the first patient with the eShunt system in the STRIDE trial marks an important milestone for Cerevasc by providing a potential new treatment option for patients with NPH and for the medical community, which has expressed considerable enthusiasm about the promise of the eShunt system,” said Dan Levangie, the company’s chairman and chief executive officer (CEO). “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. 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.”
