eShunt® System Receives FDA Breakthrough Device Designation
CereVasc, Inc. received FDA Breakthrough Device Designation for its eShunt System, aimed at treating Normal Pressure Hydrocephalus (NPH). This designation facilitates priority review and enhanced FDA communication. The eShunt System offers a minimally invasive treatment option for NPH, addressing a significant unmet need with over 700,000 affected individuals in the US.
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eShunt® System Receives FDA Breakthrough Device Designation
CereVasc, Inc. received FDA Breakthrough Device Designation for its eShunt System, aimed at treating Normal Pressure Hydrocephalus (NPH). This designation facilitates priority review and enhanced FDA communication. The eShunt System offers a minimally invasive treatment option for NPH, addressing a significant unmet need with over 700,000 affected individuals in the US.