CereVasc's eShunt System Receives FDA Breakthrough Designation for Pediatric Use

CereVasc Fosters Innovation in Pediatric Neurology with FDA Approval

CereVasc, Inc., a trailblazer in developing medical devices for neurological disorders, proudly announced the receipt of a second Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This recognition is dedicated to their investigational eShunt® System, specifically intended for treating pediatric patients aged 12 and above who suffer from communicating hydrocephalus.

The company's efforts to enhance treatment options for this vulnerable population were bolstered by compelling data revealed during pilot clinical studies, alongside ground-breaking research published in the Journal of NeuroInterventional Surgery. Conducted in leading institutions such as Texas Children’s Hospital and Oregon Health and Sciences University, the study retrospectively assessed two groups of fifty consecutive patients using high-resolution brain MRI.

Analyzing the Findings

The research meticulously evaluated the anatomy of the inferior petrosal sinus (IPS) and cerebellopontine angle cistern (CPAC) using established parameters to determine the viability of safely implanting the eShunt System. Through regression analyses, researchers scrutinized relationships between patient age and IPS/CPAC measurements. The promising results demonstrated that over 67% of the 100 examined pediatric patients met the essential anatomical criteria for the endovascular shunt placement. Interestingly, there were negligible age-based differences in treatment eligibility (P=0.57), indicating that most patients over the age of one satisfied the placement criteria for the eShunt System.

Commitment to Innovation

Dan Levangie, CereVasc's Chairman and CEO, shared insights into the significance of this designation, mentioning, “The acknowledgment of Breakthrough Device status for the eShunt® System in the pediatric demographic highlights the crucial need for innovation in treatments tailored for these patients. Our dedication to ensuring accessibility to this minimally invasive and effective option demonstrates our commitment to overcoming the challenges posed by hydrocephalus.”

Earlier this year, CereVasc disclosed results from a U.S.-based investigational study involving 30 elderly patients diagnosed with Normal Pressure Hydrocephalus (NPH). This study achieved both Primary Safety and Efficacy Endpoints, with no serious adverse events or unpredicted device effects reported within 90 days. An impressive 97% of the patients exhibited clinical improvements in symptoms of NPH, including enhanced cognitive abilities and better urinary function.

Understanding Normal Pressure Hydrocephalus

Normal Pressure Hydrocephalus predominantly affects adults over the age of 60. The Hydrocephalus Association estimates around 800,000 older Americans may have this condition, yet a staggering 80% of cases remain either unrecognized or inadequately treated. Patients suffering from NPH often face misdiagnosis, mistaking their symptoms for those of Alzheimer’s disease, Parkinson’s disease, strokes, or even normal aging. Fortunately, NPH is one of the few treatable forms of dementia, marking the importance of accurate and timely intervention.

About CereVasc, Inc.

Strategically positioned in Massachusetts, CereVasc, Inc. is at the forefront of developing minimally invasive medical solutions for neurological disorders. The innovative eShunt System represents a significant advancement, providing a new pathway for treating communicating hydrocephalus without the need for extensive surgical procedures. The device, conceived by esteemed physicians at Tufts Medical Center, aims to transform the landscape of pediatric neurovascular treatments.

For more details, visit CereVasc's official website and stay updated on their groundbreaking progress and contributions to patient care.