Aleva Neurotherapeutics, a developer of implants for deep brain stimulation (DBS) in neurological indications such as Parkinson’s disease and essential tremor, has received 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 exchange of information between Aleva and the FDA, whereby all safety tests and clinical data have been 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.
Stefano Alfonsi, CEO of Aleva Neurotherapeutics, said: “This is a pivotal milestone for Aleva 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 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 personalise 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.
