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 starting 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 21, 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 providing the benefits of our truly directional DBS system to US patients and the community of Neurologists and Neurosurgeons. The North American DBS market is definitely the largest in volume and turnover, and we are convinced that the innovation provided by directSTIM™ combined with our vision will make a dent in this space.”
Aleva’s revolutionary DBS system incorporates directional electrode technology that is designed to be more precise and efficient than currently available approaches, as targeted stimulation has the potential to improve therapeutic benefits while reducing side effects. Aleva is the only DBS company that provides 24 independent current sources in combination with the only lead that has 12 directional contacts. The result is higher flexibility during surgery and the ability to personalize therapy to the patient’s evolving needs. Aleva’s vision is to create a digital AI-powered ecosystem that integrates clinical data to generate insights that power the surgical and programming experience to achieve better lives for patients.