CereVasc announced today that it received FDA breakthrough device designation for its eShunt system for treating normal pressure hydrocephalus (NPH).
The company said data generated during pilot clinical studies of the device supported the breakthrough device designation. This designation enables priority review and enhanced communication with the FDA during the clinical trial and premarket review process.
eShunt offers a minimally invasive endovascular treatment option. It has 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, featuring a self-expanding nitinol anchor.
CereVasc initiated a pilot study of its eShunt system under investigational device exemption (IDE) in August 2022. Last September, it picked up a separate IDE supplement for a study of the next-generation eShunt system.
In May, Boston-based CereVasc received the FDA’s go-ahead to begin its STRIDE pivotal study under IDE. The company also completed the initial closing of a Series B round worth $70 million a few months ago
CereVasc expects to begin enrollment in the second half of 2024. Chair and CEO Dan Levangie said in a news release that the patients, caregivers and clinicians all registered “strong interest” in the eShunt.
“Our team is thrilled to achieve this milestone and to have the eShunt System recognized by the FDA as a breakthrough device. The ability to collaborate with FDA under the breakthrough program will support our goal to bring an endovascular option to the treatment of patients with NPH,” Levangie said.
