First Patient Treated in the CereVasc® Clinical Trial of the eShunt® System for Normal Pressure Hydrocephalus
Clinical trial in progress at Argentina to study the minimally invasive treatment of NPH
BOSTON, April 25, 2022 /PRNewswire/ — CereVasc, Inc., a privately-held clinical-stage medical device company developing new minimally invasive treatments for neurological diseases, today announced that the first patient has been treated in its clinical study of the eShunt system in patients with normal pressure hydrocephalus (NPH).
Following the approval of argentina National Administration of Medicines, Foods and Medical Devices (ANMAT) to conduct the second study of its eShunt system in Argentinathe trial was initiated under the direction of Dr. Pedro Lylyk and is titled “Pilot Study to Evaluate the Safety and Efficacy 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. this innovative minimally invasive device in patients with NPH, a condition that affects many elderly patients.We believe that the eShunt system could be an attractive option over currently available treatments,” said Dr. Lylyk.
“We are very pleased to have received approval from ANMAT to initiate a second clinical study of the eShunt System and are excited to continue working with Dr. Lylyk and his experienced team. We believe the study will demonstrate the safety and the effectiveness of the eShunt System in addressing the triad of symptoms experienced by patients diagnosed with normal pressure hydrocephalus,” said Dan Levangie, Chairman and CEO of CereVasc. “NPH is a disorder with increasing prevalence worldwide. The Hydrocephalus Association estimates that NPH affects more than 700,000 elderly patients in the United States and worldwide, the prevalence of NPH is estimated at 175 per 100,000 , representing millions of elderly patients who could benefit from alternative treatment.”
Details of the trial are available at www.clinicaltrials.gov.
On Pedro LylykMD
Since 1986, Dr. Lylyk has been dedicated to the development and improvement of devices and therapeutic options to improve the field of endovascular neurosurgery and is a global benchmark 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 has also developed a training program in endovascular neurosurgery and interventional radiology at ENERI (Equipo de Neurocirugía y Radiología Intervencionista) and Clínica La Sagrada Familia for the benefit of young doctors from all over the world. Its endovascular laboratory is one of the training centers for SILAN (Sociedad Iberolatinoamericana de Neurorradiología Diagnóstica y Terapéutica) fellows, which has trained more than 100 professionals since 1995.
Among his extensive academic training, he holds the chair of the Universidad del salvador (USAL), the University of Business and Social Sciences (UCES) and the University of Buenos Aires (UBA), Founder and President of the FENERI Foundation (Fundación para el Studio of 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). Professor Lylyk is the current President of the Argentine Stroke Association (AAAC); he directs 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 agreement with the World Stroke Organization at the Stroke Understanding Center of Buenos Aires at the La Sagrada Familia clinic, of which he is the general manager.
About CereVasc, Inc.
Situated in Massachusetts’ healthcare center, CereVasc, Inc., is a venture capital-backed medical device company focused on developing new, 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 doctors at Tufts Medical Center Carl HeilmanMD, Chief Neurosurgeon and Chairman of Neurosurgery, and Adel Malek, MD, PhD, Neurosurgeon and Chief of Neurovascular Surgery. The patented eShunt system includes an endovascularly implantable cerebrospinal fluid (CSF) shunt and delivery components, designed to treat CH without invasive surgery. For more information, please visit our website at www.cerevasc.com.
The eShunt system is an experimental device and is not available for sale indoors or outdoors United States.
Isaacs AM, Riva-Cambrin J, Yavin D, et al. : Global age-specific epidemiology of hydrocephalus: systematic review, meta-analysis and global birth surveillance. PLoS One 13: e0204926, 2018 Other epidemiological reports on iNPH
Few iNPH-focused prevalence surveys have been conducted on patients with conditions such as dementia, gait disturbance, and parkinsonism. According to a 2018 iNPH meta-analysis, the average prevalence of iNPH in the general population worldwide is 175 per 100,000; it is 400 per 100,000 in the population aged 80 and over, indicating that the prevalence increases with age. The majority of epidemiological reports on this disease Asia come from Japanand the average prevalence reported in these studies is 660 per 100,000. However, the average prevalence in countries other than Japan is 53 per 100,000. The prevalence of iNPH in Asiaespecially in Japanis higher than that of Europe or North America.
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