First patient treated in CereVasc® clinical trial of eShunt® System for Normal Pressure Hydrocephalus
Clinical trial underway in Argentina to study minimally invasive treatment for NPH
BOSTON, April 25, 2022 /PRNewswire/ — CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel, minimally invasive treatments for neurological diseases, announced today that the first patient has been treated in its clinical study of the eShunt System in patients with Normal Pressure Hydrocephalus (NPH).
Following approval from Argentina’s National Administration of Drugs, Foods, and Medical Devices (ANMAT) to conduct the second study of its eShunt System in Argentina, the trial has been initiated under the leadership of Dr. Pedro Lylyk and is titled “Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc eShunt System in the Treatment of Normal Pressure Hydrocephalus.”
“Our experience with the eShunt System in patients with hydrocephalus secondary to post-aneurysmal subarachnoid hemorrhage has been promising with encouraging initial results. The Clinica Sagrada Familia team is thrilled to expand the study of this minimally invasive, innovative device in patients with NPH, a condition that impacts many elderly patients. We believe the eShunt System could provide an attractive option to currently available treatments,” said Dr. Lylyk.
“We are very excited to have received ANMAT approval to initiate a second clinical study of the eShunt System and are delighted to continue to work with Dr. Lylyk and his experienced team. We believe the study will demonstrate the safety and efficacy of the eShunt System to address the triad of symptoms experienced by patients diagnosed with Normal Pressure Hydrocephalus,” said Dan Levangie, Chairman and CEO of CereVasc. “NPH is a disorder of growing prevalence globally. The Hydrocephalus Association estimates NPH effects more than 700,000 elderly patients in the U.S. and globally, the prevalence of NPH is estimated to be 175 per 100,000, representing millions of elderly patients who could benefit from an alternative treatment.”
Details on the trial are available at www.clinicaltrials.gov.
About Pedro Lylyk, MD
Since 1986, Dr. Lylyk has been dedicated to the development and improvement of devices and therapeutic options to enhance the endovascular neurosurgical field and represents a worldwide reference for the medical device industry. Recognized as the first to place an intracranial stent in 1996, he has treated more than 10,000 brain aneurysms and 11,000 arteriovenous malformations at his endovascular center in Buenos Aires. He also developed an endovascular neurosurgery and interventional radiology training program at ENERI (Equipo de Neurocirugía y Radiología Intervencionista) and Clínica La Sagrada Familia for benefit of young physicians from all over the world. His endovascular lab is one of the training centers for SILAN (Sociedad Iberolatinoamericana de Neurorradiología Diagnóstica y Terapéutica) fellows, which has allowed the training of more than 100 professionals since 1995.
Among his extensive academic background, he is Chair at the Universidad del Salvador (USAL), University of Business and Social Sciences (UCES) and the University of Buenos Aires (UBA), Founder and President of FENERI Foundation (Fundación para el Estudio de las Neurociencias y la Radiología Intervencionista), Co-Founder of the Cerebrovascular Research and Education Foundation (CREF), Intracranial Stent Meeting and Society (ICS), and CANI (Colegio Argentino de Neurointervencionistas). Prof. Lylyk is the current President of the Argentine Stroke Association (AAAC); he leads the Member of the SwissNeuroFoundation, Founding member and former President of SILAN, (Sociedad Iberolatinoamericana de Neurorradiología Diagnóstica y Terapéutica), AANDIT (Asociación Argentina de Neurorradiología Diagnóstica y Terapéutica), and National Stroke Prevention Campaign in line with the World Stroke Organization at the Comprehension Stroke Center of Buenos Aires at La Sagrada Familia Clinic of which he is the General Director.
About CereVasc, Inc.
Located in Massachusetts’ healthcare hub, CereVasc, Inc., is a clinical-stage, venture-funded, medical device company focused on the development of novel, minimally invasive treatments for patients with neurological diseases. Its flagship product, the eShunt System, is intended to offer the first minimally invasive treatment for communicating hydrocephalus (CH) and an improvement to the current standard of care. The eShunt device concept originated from Tufts Medical Center physicians Carl Heilman, MD, Neurosurgeon-in-Chief and Chairman of Neurosurgery, and Adel Malek, MD, PhD, Neurosurgeon and Chief of Neurovascular Surgery. The patented eShunt System includes an endovascularly implantable cerebral spinal fluid (CSF) shunt and delivery components, which are designed to treat CH without invasive surgery. For additional information, please visit our website at www.cerevasc.com.
The eShunt System is an investigational device and not available for sale within or outside the United States.
Isaacs AM, Riva-Cambrin J, Yavin D, et al.: Age-specific global epidemiology of hydrocephalus: systematic review, metanalysis and global birth surveillance. PLoS One 13: e0204926, 2018 Other epidemiological reports on iNPH
Few prevalence surveys focusing on iNPH have been conducted on patients with diseases such as dementia, gait disturbance, and Parkinsonism. According to a 2018 meta-analysis of iNPH, the mean prevalence of iNPH in the general population worldwide is 175 per 100000; it is 400 per 100000 in the population aged 80 years and above, indicating that the prevalence increases with age. The majority of epidemiological reports on this disease from Asia are from Japan, and the mean prevalence reported in these studies is 660 per 100000. However, the mean prevalence in countries other than Japan is 53 per 100000. The prevalence of iNPH in Asia, particularly in Japan, is higher than that in Europe or North America.