Cerevasc has announced results from a prospective, multicentre, single-arm study evaluating the safety and clinical outcomes associated with the endovascular eShunt system in patients with normal-pressure hydrocephalus (NPH). The results have been published in the Journal of NeuroInterventional Surgery (JNIS).
Sixty-six patients were treated at 12 sites across the USA and Argentina in the study. As outlined in a recent press release from Cerevasc, key results through 90-day follow-up include a 0% rate of device-related serious adverse events (SAEs), a 3% rate of procedure-related SAEs—all resolved without surgical intervention—and some 95% of participants demonstrating improvement in at least one of the three primary clinical symptoms of NPH, which are gait disturbance, cognitive impairment and urinary incontinence.
Additionally, statistically significant improvement from baseline was documented in all three of these primary clinical symptoms of NPH. There were also zero observations of symptomatic or radiologic cerebral haemorrhage, or over-drainage—confirmed by blinded, independent core lab magnetic resonance (MR) and computed tomography (CT) image analysis—as well as zero instances of infection related to the procedure or device.
“The outcomes achieved in this study are highly encouraging,” said Charles Matouk (Yale School of Medicine, New Haven, USA). “The favourable safety profile, along with statistically significant symptom improvements observed at the 90-day follow-up, provides an early clinical signal that supports continued evaluation of an endovascular approach for the treatment of NPH.”
“We believe the eShunt system represents a significant advancement in the treatment of NPH, and we are eager to further evaluate these results in the STRIDE randomised controlled pivotal trial,” added Dan Levangie, chairman and chief executive officer (CEO) of Cerevasc. “The STRIDE trial is the first head-to-head comparison of conventional shunting to the minimally invasive eShunt system and, with the data generated to date and enthusiasm from practitioners and patients, we remain focused on advancing this innovation toward a potential new standard of care for patients with NPH.”
“NPH remains challenging to diagnose and manage, and conventional shunting is associated with well-documented risks and variability in outcomes,” commented Pedro Lylyk (Clinica la Sagrada Familia, Buenos Aires, Argentina). “These early results suggest that an endovascular approach may offer NPH symptom improvement while providing a treatment with potentially fewer complications and adverse events. This is an exciting milestone in advancing care for this patient population.”
According to Cerevasc, the STRIDE pivotal trial is currently enrolling patients at 28 sites in the USA, Argentina and Canada to compare the eShunt system versus conventional ventriculoperitoneal shunting. The results of the STRIDE trial will serve as the basis for Cerevasc’s anticipated submission to regulatory agencies for approval to market the eShunt system, the company adds.
First-in-human IIH treatment
In a separate press release, Cerevasc also recently shared that the first-in-human use of the eShunt system in the treatment of medically refractory idiopathic intracranial hypertension (IIH) has been described via a case report published in Stroke: Vascular and Interventional Neurology.
Led by Lylyk and colleagues at the Eneri Medical Institute in Buenos Aires, Argentina, the case involved a 50-year-old man with chronic IIH whose symptoms had progressed despite treatment with acetazolamide and serial lumbar punctures. Following regulatory and ethics approval for compassionate use, the patient underwent minimally invasive endovascular treatment with the eShunt system.
At 35-day follow-up, the patient reported an improvement in headaches, diplopia, and overall quality of life, with symptom improvements being reported at both five months and three years too. This initial follow-up also showed reduced cerebrospinal fluid (CSF) opening pressure compared to pretreatment baseline opening pressure.
At five-month follow-up, the patient was able to discontinue acetazolamide and non-steroidal anti-inflammatory medications. At three-year follow-up, MR imaging demonstrated that the eShunt implant had maintained patency alongside achieving sustained CSF drainage. Additionally, no device- or procedure-related complications—including over-drainage, thrombosis, stroke, occlusion, displacement or subdural collections—were observed during follow-up.
“The eShunt system offers a novel, minimally invasive endovascular approach that successfully reduced intracranial pressure, alleviated optic nerve oedema and provided sustained symptomatic relief in this medically refractory IIH patient, with device patency maintained through three years of follow-up,” said Lylyk, who is also the lead author for the case report.
“This first-in-human experience of the eShunt system in idiopathic intracranial hypertension highlights the potential of our minimally invasive technology to expand treatment options for patients living with elevated intracranial pressure,” Levangie added. “By emulating natural CSF drainage pathways without open surgery, the eShunt system is designed to address limitations of current therapies, and supports our ongoing commitment to advancing solutions that improve patient outcomes and quality of life.”
