CereVasc, LLC Receives Approval to Initiate First-in-Human Clinical Study of the eShunt™ System
BOSTON, Nov. 4, 2019 /PRNewswire/ -- CereVasc, LLC, a company focused on improving the treatment of communicating hydrocephalus patients, announced today that Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) approved the Company’s request to conduct a clinical study titled “Endovascular Treatment of Communicating Hydrocephalus with the eShunt System” (ETCHES I). The study will be conducted in Buenos Aires, Argentina under the leadership of Principal Investigator Dr. Pedro Lylyk, M.D., and is scheduled to begin enrollment during the first quarter of 2020.
“We are delighted to have received ANMAT approval to begin a clinical evaluation of our system. We believe the study design will demonstrate the safety and efficacy of the eShunt procedure to reduce intracranial pressure in patients with communicating hydrocephalus secondary to post-aneurysmal subarachnoid hemorrhage. This patient population presents a number of management challenges to physicians, and we believe that an endovascular treatment option will improve the overall care and outcomes in this population,” said Dan Levangie, Chairman & CEO of CereVasc, LLC.
“We are excited to lead the first clinical study of this novel approach to treating hydrocephalus patients. Our team of interventional physicians and support staff are eager to play a role in transforming a 60-year-old standard of care into a minimally invasive, innovative approach using the eShunt System. Having been involved in a number of other ‘firsts’ in the field, we believe our Clinica Sagrada Familia team is very well equipped to conduct this initial evaluation,” said Dr. Lylyk.
About Pedro Lylyk, MD
Since 1986 he is 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, as of then, he has performed more than 10,000 Brain Aneurysms and 11,000 AVM’s at his Endovascular Center in Buenos Aires, while developing the 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); 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 Ex 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 in which he is the General Director.
About CereVasc, LLC
CereVasc, LLC is a medical device company focused on the development of novel, minimally invasive treatments for patients with neurological diseases. The Company’s first product, the eShunt™ System, is an endovascularly deliverable cerebrospinal fluid shunt and associated delivery componentry designed to avoid the need for invasive surgery, general anesthesia and hospitalization associated with the current surgical treatment of communicating hydrocephalus using ventriculo-peritoneal shunts.
SOURCE CereVasc, LLC