Small device, significant impact

For the estimated 800,000 older Americans living with normal pressure hydrocephalus (NPH) — a debilitating condition that causes progressive cognitive decline, difficulty walking and urinary incontinence — hope has long been tied to invasive brain surgery.

Now, Dr. Justin F. Fraser, vice-chair of Neurosurgery and director of Cerebrovascular Surgery and Neurointerventional Radiology at UK HealthCare, is leading studies on a minimally invasive alternative that likely will revolutionize care for those with NPH. 

Normal pressure hydrocephalus occurs when cerebrospinal fluid (CSF) accumulates in the brain’s ventricles. Normally, CSF cushions the brain and spinal cord, delivers nutrients and eliminates waste. But when there’s a blockage or disruption that doesn’t allow for proper circulation, the pressure climbs, leading to symptoms that often require surgery. 

The minimally invasive approach has yielded striking results. In 2024, Fraser and his team performed the first procedure in the U.S. using the CereVasc eShunt System as part of an Investigational Device Exemption (IDE) trial to evaluate the device’s safety and effectiveness.

Outcomes include: 
•    97% of patients experienced improvement in clinical symptoms of NPH
•    No Serious Adverse Events (SAEs) related to the study device or procedure 
•    No Unanticipated Adverse Device Effects 
•    Average Length of Hospital Stay of 1.3 days

“It holds a lot of promise for patients,” Dr. Fraser said. “We take the endovascular shunt, or eShunt, up through the blood vessels percutaneously — almost like having a heart catheterization. And we place this tiny one-way valve into the brain, rerouting the pathway of the spinal fluid.” 

The success of that trial has led to its second iteration. The STRIDE clinical trial is a randomized, controlled trial comparing the new eShunt System with the standard of care (the placement of a shunt through open surgery). 

“One of the things to understand about shunts is that they’re similar to maintaining a car. Everything runs smoothly at first, but then they need some maintenance a few years later,” Dr. Fraser said.

“While there are risks with any procedure, open surgery places older patients at a higher risk of a complication, such as infection or bleeding when compared to a minimally invasive procedure. Whether it’s for the initial stent placement or for a follow-up, this advancement gives us another option for patients.”