Aleva Neurotherapeutics: U.S. FDA grants Aleva Neurotherapeutics approval for an Investigational Device Exemption (IDE) study on directSTIM Directional Deep Brain Stimulation System

Aleva is committed to start the PMA trial in the next quarters, in parallel with the post-market clinical follow-up study currently underway in select European neurological clinics. The US trial will include up to 15 US institutions with the recruitment of up to 136 US patients. Lausanne, Switzerland, February, 2022 - Aleva Neurotherapeutics, a developer of innovative implants for deep brain stimulation (DBS) in major neurological indications such as Parkinson's disease and essential tremor, today announced they have received a letter of approval from the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) study. The approved protocol has been designed to collect safety and efficacy data to support submission for a future PMA application. The approval has been granted following an intensive exchange of information between Aleva and the FDA, whereby all safety tests and clinical data have been scrupulously investigated. This authorisation follows the grant of the CE-Mark in Europe, and the ongoing post-market clinical follow-up study in select European neurological clinics whose completion is expected in the next 30 months. "This is a pivotal milestone for Aleva" commented Stefano Alfonsi, CEO of Aleva Neurotherapeutics "as we are fully committed to provide the benefits of ...