Cerevasc has announced that the US Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) supplement to permit the expansion of a study of its eShunt system in patients with normal-pressure hydrocephalus (NPH) to additional study participants and clinical sites.
This IDE supplement approval also allows for use of the next-generation eShunt system in the NPH study. According to a company press release, the Gen2 eShunt system has been designed to simplify the device preparation process, and enhance the system’s overall ease of use, while maintaining eShunt implant performance.
“The early results we have seen in our pilot study of the eShunt system in treating patients with iNPH [idiopathic normal-pressure hydrocephalus] have been positive, and we could not be more excited about the opportunity to have Generation 2 of the eShunt system evaluated in an expanded NPH pilot study in the USA,” said Dan Levangie, Cerevasc president and CEO.
“Our development team has thoughtfully incorporated feedback from our study investigators and our collaborators, Pedro Lylyk, Carl Heilman, and Adel Malek, to improve the usability of the system without compromising functionality or patient safety, and are looking forward to its use in the study.”