CereVasc’s eShunt Evaluated in Pilot Study of Elderly Patients With NPH

February 5, 2025—CereVasc, Inc. announced the initial results of its United States pilot clinical study of the CereVasc eShunt system in the treatment of elderly patients with normal pressure hydrocephalus (NPH).

According to the company, the objective of the prospective, nonrandomized, open-label, multicenter study is to evaluate the safety and efficacy of the eShunt system procedure. The study is being conducted under an FDA-approved investigational device exemption.

The study includes patients with NPH for whom a traditional cerebrospinal fluid shunt implant is indicated. It is being conducted at 11 academic medical centers in the United States.

CereVasc reported the initial study results in 30 elderly patients who were treated with its eShunt system in the United States. Both the primary safety and primary efficacy endpoints were achieved.

As outlined in the CereVasc’s press release, key findings at 90 days include:

• Improvement in clinical symptoms of NPH in 97% of treated patients (29/30)
• No serious adverse events related to the study device or procedure
• No unanticipated adverse device effects
• Average length of hospital stay of 1.3 days

The company noted that published data on conventional open surgical shunt procedures for NPH have documented a 25.15% rate of complications or hospital readmission within 30 days of ventricular shunting and an average hospital stay length of 3 days.

Clinical symptoms include gait measured by the Timed Up and Go test, cognitive function measured by the Montreal Cognitive Assessment, and urinary function measured by the Neurogenic Bladder Symptom Score.

“The results of this study show that an endovascular approach to treating NPH may improve overall care and clinical outcomes,” commented Charles Matouk, MD, in CereVasc’s press release. “A minimally invasive approach will allow us to make treatment available to more patients.” Dr. Matouk is Chief of Neurovascular Surgery at Yale New Haven Health in New Haven, Connecticut

CereVasc advised that the safety and effectiveness of the eShunt device have not yet been fully established. It is an investigational device and has not been approved by FDA or any other regulatory agency for commercial sale.

On January 14, 2025, CereVasc announced that the first patient was enrolled in the STRIDE clinical trial of the eShunt system for patients with NPH. The results of the STRIDE trial will serve as the basis for the company’s future premarket approval submission to the FDA.

The company stated that the eShunt system uses percutaneous transvenous-transdural access to the central nervous system to allow the first minimally invasive treatment for communicating hydrocephalus. The system includes an endovascularly implantable cerebral spinal fluid shunt and delivery components. The eShunt device concept originated from Carl Heilman, MD, and Adel Malek, MD, from Tufts Medical Center in Boston, Massachusetts.