Cerevasc has announced it has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its eShunt system, which is intended for the treatment of normal-pressure hydrocephalus (NPH).
The Breakthrough Device designation was supported by data generated during pilot clinical studies of the device, according to a recent press release from Cerevasc.
“Our team is thrilled to achieve this milestone and to have the eShunt system recognised by the FDA as a Breakthrough Device. The ability to collaborate with FDA under the breakthrough programme will support our goal to bring an endovascular option to the treatment of patients with NPH,” said Dan Levangie, the company’s chairman and chief executive officer. “It is estimated that more than 700,000 individuals in the USA suffer from NPH with the vast majority going untreated. Consequently, we have seen strong interest among patients, caregivers and clinicians in an endovascular treatment option to address this significant health challenge.”
Cerevasc notes that this recent designation will enable priority review and enhanced communication with the US FDA during the clinical trial and premarket review process.
The company was also recently granted an investigational device exemption (IDE) for its STRIDE pivotal study evaluating the eShunt system for the treatment of NPH, with enrolment on track to begin in the second half of 2024.
