Aleva's directSTIM system is C.E. marked for sale in Europe as a treatment for Parkinson’s disease and essential tremors. The company has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) study. This marks a major step in bringing the device to the U.S market.
EPFL Spinoff Aleva Neurotherapeutics develops implants for deep brain stimulation (DBS) based on MEMS technology. Its microfabricated devices enable Target Specific Stimulation and optimisation of current therapies. The first application is in DBS for neurological indications such as Parkinson’s Disease and Essential Tremor.
Following directSTIM’s C.E. marking, the startup started its commercial journey by partnering with the leading neurological clinics in Europe, aiming to penetrate the most relevant worldwide markets soon.
The U.S. Food and Drug Administration (FDA) granted Aleva Investigational Device Exemption (IDE) study after an intensive exchange of information in the investigation of all safety tests and clinical data. The approved protocol has been designed to collect safety and efficacy data to support submission for a future PMA application.
“This is a pivotal milestone for Aleva”, commented Stefano Alfonsi, CEO of Aleva Neurotherapeutics. “We are fully committed to providing the benefits of our truly directional DBS system to U.S. patients and the community of Neurologists and Neurosurgeons. The North American DBS market is 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.”
(Press release/RAN)
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