CereVasc announced today that it completed the first procedure with its eShunt device in the U.S. as part of a pilot study.
Boston-based CereVasc’s first eShunt procedure was completed as part of a U.S. pilot study of the system in normal pressure hydrocephalus (NPH) being conducted under FDA investigational device exemption (IDE). Approval for the trial came from the FDA in February.
Dr. Charles Matouk, associate professor of neurosurgery, vice chair of clinical affairs for neurosurgery and chief of neurovascular surgery at Yale Medicine, treated the patient.
“We are pleased to participate in this study of the eShunt System, a promising device with the potential to transform the care of patients with NPH using a minimally invasive approach as opposed to open surgery,” Matouk said in a news release.
CereVasc Chair and CEO Dan Levangie added: “This study, which will evaluate the safety and efficacy of the eShunt System, represents a significant milestone for the company and the neurovascular field, as we advance our solution for the millions of people across the world that suffer from NPH through the clinical pathway.”