Multicenter Pivotal Trial Planned for 2024
BOSTON, Oct. 3, 2023 /PRNewswire/ — CereVasc, LLC, a clinical-stage, medical device company developing novel treatments for neurological diseases, announced a milestone thirtieth patient received the eShunt Implant as part of the ongoing pilot studies investigating the use of the System for the treatment of communicating hydrocephalus.
The pilot studies are being conducted in Argentina under regulatory approval by the National Administration of Drugs, Food and Medical Devices (ANMAT) and in the United States under Investigational Device Exemption (IDE) approval by the FDA, the first for the study of a minimally invasive treatment for communicating hydrocephalus.
The thirtieth procedure was performed by Dr. Pedro Lylyk, General Director of the Comprehensive Stroke Center at Clinica la Sagrada Familia in Buenos Aires, Argentina who also performed the first eShunt Procedure in the world. Dr. Lylyk stated, “Providing patients with the option of a minimally invasive treatment for hydrocephalus could evoke a new paradigm in neurovascular surgery. We look forward to continuing our work with the CereVasc team to advance the study of the eShunt System.”
Dan Levangie, CereVasc President & CEO stated, “The entire CereVasc team is grateful to our partners, clinical site physicians and research teams, and medical advisors who have helped us reach this critical milestone of 30 patients treated with the eShunt System. The data generated by this robust body of clinical work will support the advancement of the eShunt System into a pivotal phase next year.”
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, medical device company focused on the development of novel, minimally invasive treatments for patients with neurological diseases. Its initial product, the eShunt System, encompasses first-ever, groundbreaking percutaneous transvenous-transdural access to the central nervous system intended to allow the first minimally invasive treatment for communicating hydrocephalus (CH), a potential improvement to the current standard of care. The eShunt device concept originated from Tufts Medical Center physicians Carl Heilman, MD, Neurosurgeon-in-Chief and Chair of Neurosurgery, and Adel Malek, MD, PhD, Chief of Neurovascular Surgery and Director of Endovascular Neurosurgery. 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® Device is an investigational device and not available for sale within or outside the United States.
Company Contacts:
DJ Cass
CereVasc, Inc.
djcass@cerevasc.com
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SOURCE CereVasc, Inc.
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