CereVasc, Inc. has announced that its eShunt System has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the treatment of Normal Pressure Hydrocephalus (NPH). This designation is supported by data from pilot clinical studies and aims to expedite the development and review process for this novel treatment option.
Significance of Breakthrough Device Designation
The FDA's Breakthrough Device program is designed to provide patients and healthcare providers with timely access to innovative medical devices that have the potential to offer more effective treatment for life-threatening or irreversibly debilitating diseases or conditions. The designation allows CereVasc to have priority review and enhanced interaction with the FDA during clinical trials and the premarket review phase.
The eShunt System: A Minimally Invasive Approach
The eShunt System is designed as a minimally invasive alternative to traditional surgical methods for treating communicating hydrocephalus (CH). It involves a percutaneous transvenous-transdural approach to the central nervous system, allowing for the implantation of a cerebral spinal fluid shunt without invasive surgery. The device concept originated from physicians at Tufts Medical Center.
Dan Levangie, Chairman and CEO of CereVasc, stated, "Our team is thrilled to achieve this milestone and to have the eShunt System recognized by the FDA as a Breakthrough Device... It is estimated that more than 700,000 individuals in the US suffer from NPH with the vast majority going untreated. Consequently, we have seen strong interest among patients, caregivers, and clinicians in an endovascular treatment option to address this significant health challenge."
STRIDE Pivotal Study
CereVasc has received an Investigational Device Exemption (IDE) for its STRIDE pivotal study, which will evaluate the eShunt System for the treatment of NPH. Enrollment for the study is on track to begin in the second half of 2024. The study aims to provide further clinical evidence supporting the safety and efficacy of the eShunt System.
About Normal Pressure Hydrocephalus
Normal Pressure Hydrocephalus (NPH) is a neurological condition characterized by an abnormal buildup of cerebrospinal fluid in the brain's ventricles, which can lead to symptoms such as gait disturbance, cognitive impairment, and urinary incontinence. Current treatment options primarily involve the surgical implantation of shunts to drain excess fluid, a procedure associated with potential complications. The eShunt System offers a less invasive approach that could potentially reduce these risks.
