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The system will be part of a NPH study.
CereVasc, Inc., announced that FDA has approved an investigational device exemption (IDE) to CereVasc’s eShunt System.
This approval will allow the treatment to be used in a study of patients with Normal Pressure Hydrocephalus, as revealed in a press release from the company.
The device is a minimally invasive treatment for communicating hydrocephalus. The device includes a implantable cerebral spinal fluid shunt, which is used in place of invasive surgery to deliver treatment.
"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", CereVasc President and CEO Dan Levangie said in a press release. "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.”
(Sept. 18, 2023); PR Newswire; CereVasc Receives FDA IDE Approval to Expand its Clinical Study of Patients with Normal Pressure Hydrocephalus Utilizing the Generation 2 eShunt System; https://www.prnewswire.com/news-releases/cerevasc-receives-fda-ide-approval-to-expand-its-clinical-study-of-patients-with-normal-pressure-hydrocephalus-utilizing-the-generation-2-eshunt-system-301929388.html