CereVasc, a clinical-stage, medical device company developing novel treatments for neurological diseases, announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) supplement to permit the expansion of the study of the eShunt System in patients with Normal Pressure Hydrocephalus (NPH) to additional study participants and clinical sites.
The IDE supplement approval also allows for use of the next generation eShunt System in the NPH study. The Gen2 eShunt System has been designed to simplify the device preparation process, enhance the overall ease of use of the system, while maintaining eShunt Implant performance.
“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, Pedro Lylyk, M.D., Carl Heilman, M.D., and Adel Malek, M.D., Ph.D. to improve the usability of the system without compromising functionality or patient safety and are looking forward to its use in the study,” he continued.
Source: Company Press Release
