Cerevasc has announced that data from clinical studies in the USA and Argentina examining the use of its eShunt system to treat communicating hydrocephalus were presented at the recent ABC WIN Seminar (15–20 January, Val d’Isère, France).
Data from clinical studies of the eShunt system are being conducted under US Food and Drug Administration (FDA) investigational device exemption (IDE) approval in the USA, and National Administration of Drugs, Food and Medical Devices (ANMAT) approval in Argentina, as per a press release from Cerevasc.
These studies involve patients with hydrocephalus secondary to subarachnoid haemorrhage and also patients with normal-pressure hydrocephalus (NPH), the release adds.
Key findings were presented by Ivan Lylyk (ENERI, Buenos Aires, Argentina) in an abstract entitled, “Pilot clinical experience with the Cerevasc eShunt system for the treatment of communicating hydrocephalus”.
“We are pleased for our team to share the initial results of these 31 patients who have been treated with the eShunt system across multiple hydrocephalus aetiologies and warrants the study of the device in a pivotal trial setting,” said Pedro Lylyk (ENERI, Buenos Aires, Argentina).
“We are grateful to ABC WIN for the opportunity to have Dr Lylyk present the encouraging data from our investigators in the trials of the eShunt system,” added Cerevasc president and chief executive officer Dan Levangie. “We are looking forward to leveraging the experience gained in these studies to support our pivotal study this year.”
