CereVasc announced today that the FDA approved an investigational device exemption (IDE) supplement for a study of its eShunt system.
The FDA permitted the expansion of the study for patients with normal pressure hydrocephalus (NPH) to additional participants and sites. The company initiated the pilot study of its eShunt system under IDE in August 2022.
Boston-based CereVasc said the supplement also allows for the use of the next-generation eShunt system in the NPH study. The company designed the system to simplify the device preparation process and enhance overall ease of use while maintaining performance.
eShunt offers a minimally invasive treatment with the potential to result in benefits over the current gold-standard treatment, according to CereVasc. It includes an endovascularly implantable cerebral spinal fluid (CSF) shunt and delivery components.
“The early results we have seen in our pilot study of the eShunt System in treating patients with iNPH 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 US”, said Dan Levangie, CereVasc president & CEO. “Our development team has thoughtfully incorporated feedback from our study investigators and our collaborators, Dr. Pedro Lylyk, Dr. Carl Heilman, and Dr. 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.”