CereVasc 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 Pedro Lylyk and is scheduled to begin enrolment 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 haemorrhage. 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 and CEO of CereVasc.
“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 Lylyk.