Minimally invasive shunt may offer faster recovery in normal pressure hydrocephalus

Key takeaways:

• Normal pressure hydrocephalus is a reversible condition of dementia that primarily affects older adults.
• The eShunt System aims to provide a minimally invasive solution to open brain surgery.

Normal pressure hydrocephalus, a condition in which cerebrospinal fluid builds up in the brain, can lead to issues such as cognitive impairment, difficulty walking and bladder dysfunction.

An estimated 800,000 individuals in the United States, mainly aged older than 65 years, deal with normal pressure hydrocephalus. A new device that is less invasive than surgery may be able to help patients with the condition.

Healio spoke with Ricardo Hanel, MD, PhD, a neurosurgeon at Baptist Health in Jacksonville, Florida, to learn about the novel, minimally invasive eShunt System from CereVasc, which may improve safety, access and overall quality-of-life concerns for patients with NPH and about the pending clinical trial investigating its efficacy.

Healio: What was the impetus for the creation of the STRIDE study? What do you hope to accomplish with its completion?

Hanel: Normal pressure hydrocephalus (NPH) is characterized by three main progressive symptoms: gait disturbance, urinary incontinence and cognitive decline. While some of these symptoms are largely reversible, especially when treatment is rendered early in the course of the disease, about 80% of affected patients go undiagnosed.

Even patients who know they have NPH may not be eligible for the current standard of treatment, which involves a surgical procedure called a ventriculo-peritoneal (VP) shunt placement. Factors such as age, frailty or comorbidities may prevent patients from receiving surgery.

Baptist Health, along with more than 20 other trial site locations, is looking to expand available treatment options through its participation in the STRIDE clinical trial to evaluate the eShunt System, a novel, investigational, minimally invasive alternative, against the VP shunt, today’s primary surgical treatment for NPH.

The hope is to improve patient outcomes by making treatment accessible and safe for more patients, particularly those who are not candidates for open-brain surgery.

NPH is a reversible cause of dementia, and we are very excited at the prospect of improving opportunities for this patient population.

Healio: How can clinicians effectively address the diagnostic gap seen with normal pressure hydrocephalus?

Hanel: Diagnosing NPH can be difficult because it can mimic other diseases, such as Alzheimer’s and Parkinson’s.

Physicians can make a solid differential diagnosis by first recognizing symptoms that could be associated with NPH and assessing these symptoms. A high index of suspicion is very important. If the patient demonstrates gait impairment associated with short-term memory issues, the physician may suggest a lumbar puncture to drain excess cerebrospinal fluid (CSF) and then re-administer the test to reveal whether the patient’s mobility has improved, helping to verify NPH. A key sign to look out for can be a person’s feet appearing to be stuck or glued to the ground.

Physicians should also order a CT scan or MRI to determine if excess CSF is present and demonstrating ventricular enlargement. Although not specific to NPH, certain MRI signs may support the diagnosis.

While these tests will help physicians more accurately diagnose NPH, it’s important for caregivers and loved ones to be on the lookout for these symptoms at home as well and be aware that they may be caused by more than the typical effects of aging.

Healio: What differentiates the eShunt System from current drainage methods and how do you expect the device to affect the NPH standard of care?

Hanel: To implant the VP shunt, a catheter is passed through a burr hole drilled into the skull, into the cavity inside the brain called a ventricle, where the pool of accumulated CSF is present. Next, that catheter is connected to a longer catheter that is then passed across the collarbone and into the abdomen. These two catheters are connected via a programmable valve that allows excess CSF to drain from the ventricle into the peritoneal cavity.

This new minimally invasive method does not require a scalp incision or burr hole, nor does it need a catheter towards the abdomen or valve. Instead, a temporary delivery system is introduced into the femoral vein through a small needle in the groin and fed to the base of the brain. There, before removing the delivery system, a small catheter is implanted that will remain in place to drain CSF into the venous system to be reabsorbed by the body. This closely follows the process for how CSF would drain in a healthy individual.

Because an endovascular approach is less invasive than traditional open surgery, it could potentially offer certain advantages for patients, such as fewer complications, reduced hospital stays and fewer follow-up visits or interventions.

If the new approach shows promising results in the STRIDE study, as it demonstrated in initial studies, our hope is that more treatment options will be available to more patients.

Healio: How might the eShunt provide better access to care for the condition?

Hanel: The hope is that it will provide better access to care by expanding treatment options and reducing complications. With improved safety, more patients will be amenable to treatment. Age is a consideration when contemplating any open surgery. Elderly patients tolerate minimally invasive endovascular procedures better than traditional open neurosurgeries, so being able to offer this treatment means we could potentially serve a much larger proportion of patients with NPH.

As well as avoiding some of the risks associated with traditional brain surgery, patients can continue taking medications such as blood thinners to manage existing cardiovascular conditions.

Healio: Can you address how more efficient shunting would affect patients’ overall quality of life?

Hanel: Providing our patients a better quality of life is one of our highest priorities. We expect this new shunt to have similar efficacy compared with the VP shunt, reversing the symptoms of NPH in many patients but with fewer complications. It also has the potential to require less intervention from physicians after surgery. A lower complication rate will lead to more flexible indications for the procedure, leading to more patients receiving treatment.

Patients who have received the VP shunt sometimes experience over drainage of fluid when they change their body positions quickly, and doctors must resolve that problem by readjusting the shunt with a magnet. Over drainage can lead to brain bleed with loss of benefit of CSF drainage.

Because this new type of shunt is designed to self-adjust as patients move, the hope is that it will cause less disruption in a patient’s daily life and improve their quality of life and potentially result in the need for fewer trips to the doctor.

Reference:

CereVasc, Inc. announces results of groundbreaking clinical study of the eShunt System in the treatment of elderly patients with normal pressure hydrocephalus. https://www.prnewswire.com/news-releases/cerevasc-inc-announces-results-of-groundbreaking-clinical-study-of-the-eshunt-system-in-the-treatment-of-elderly-patients-with-normal-pressure-hydrocephalus-302368231.html. Published Feb. 5, 2025. Accessed April 30, 2025.

CSF Overdrainage. https://radiopaedia.org/articles/csf-overdrainage?lang=us. Revised July 15, 2024. Accessed April 23, 2025.

Endovascular Brain Surgery. https://www.yalemedicine.org/conditions/endovascular-brain-surgery-accessing-your-brain-through-blood-vessels. Accessed March 7, 2025.

Hydrocephalus Association. Normal Pressure Hydrocephalus (NPH) vs. Alzheimer’s and Parkinson’s. Copyright 2025. Accessed March 7, 2025. https://www.hydroassoc.org/nph-vs-alzheimers-parkinsons/.

Ventriculo-peritoneal shunt. https://brainbookcharity.org/ventriculo-peritoneal-shunt/. Published March 30, 2020. Accessed March 7, 2025.

For more information:

Ricardo Hanel, MD, PhD, can be reached at neurology@healio.com. He can be found on Facebook and Instagram at: @BaptistHealthJx.