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CereVasc, Inc. Report on eShunt® System

CereVasc, Inc., a pioneering medical device firm focused on treatments for neurological diseases, has recently shared initial findings from their pilot clinical study involving the eShunt® System. This treatment aims to assist elderly patients suffering from Normal Pressure Hydrocephalus (NPH). The study outcomes revealed highly promising data, providing a potential new direction in the management of this condition.

Study Overview

Conducted in compliance with FDA regulations under the Investigational Device Exemption (IDE) framework, the study (ClinicalTrials.gov ID NCT05232838) took place at 11 academic medical centers across the United States. A total of 30 elderly patients diagnosed with NPH for whom traditional CP shunt placement was deemed suitable, participated in this multi-center, open-label study. The main goals were to determine the safety and efficacy of the eShunt System.

Key Findings

The study's key outcomes were encouraging:

• - An impressive 97% of patients (29 out of 30) demonstrated improvement in clinical symptoms of NPH.
• - There were no reported Serious Adverse Events (SAEs) or unanticipated adverse effects related to the study device or procedure.
• - The average length of hospital stay was recorded at a mere 1.3 days.

At the 90-day primary endpoint, results reflected significant safety assurances, with no adverse occurrences documented. Furthermore, clinical improvements were noted across multiple domains:

• - Gait improvement was assessed using the Timed Up and Go (TUG) test.
• - Cognitive enhancement was evaluated through the Montreal Cognitive Assessment (MoCA).
• - Improvement in urinary symptoms was assessed via the Neurogenic Bladder Symptom Score (NBSS).

Medical Perspective

Dr. Charles Matouk, Chief of Neurovascular Surgery at Yale New Haven Health commented on the results, stating, “An endovascular approach to managing NPH may significantly enhance patient care outcomes.” He highlighted the benefits of a minimally invasive technique that could expand accessibility to treatment for more patients struggling with this debilitating disease.

The procedure’s safety profile stands in stark contrast to conventional open surgical methods, which have historically recorded a 25.15% complication or readmission rate within 30 days post-ventricular shunting, as well as an average hospital stay of 3.0 days.

Company Insights

Dan Levangie, Chairman and CEO of CereVasc, expressed enthusiasm regarding the study findings. He stated, “We are tremendously encouraged by these outstanding preliminary results, especially noting the absence of SAEs after 90 days, combined with clinical enhancements in almost all patients. This positions our endovascular approach as a possibly transformative option for this neurodegenerative disorder.”

About Normal Pressure Hydrocephalus

Normal Pressure Hydrocephalus is a neurological condition largely observed in adults aged 60 and above, affecting around 800,000 elderly Americans according to the Hydrocephalus Association. Alarmingly, it is estimated that over 80% of cases remain undiagnosed or untreated, as NPH's symptoms can easily be misinterpreted as Alzheimer’s or Parkinson’s diseases or simply attributed to aging.

About CereVasc, Inc.

Based in the healthcare hub of Massachusetts, CereVasc, Inc. is recognized for its commitment to developing cutting-edge, minimally invasive neurological treatments. The eShunt System is groundbreaking, offering the first minimally invasive option for communicating hydrocephalus (CH). The device was conceptualized by the renowned physicians at Tufts Medical Center, further underscoring its innovative foundation.

Disclaimer: The eShunt® Device is investigational and has not received formal approval from the FDA for commercial sales. Its safety and efficacy are yet to be established in full.