CereVasc today announced completion of the first eShunt procedure in the USA as part of a pilot study involving normal-pressure hydrocephalus (NPH) patients.
The study is being conducted under an investigational device exemption (IDE) approved by the US Food and Drug Administration (FDA) earlier this year, a CereVasc press release states.
The first patient was treated at Yale Medicine in New Haven, USA by Charles Matouk. “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,” said Matouk.
“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,” said Dan Levangie, chairman and CEO of CereVasc.