directSTIM™ Deep Brain Stimulation System Post-Market Clinical Follow-up Study on Essential Tremor

This is a prospective, multi-center, single arm post-market clinical follow-up study. The present study investigates a product authorized on the European market that will be used per its intended use, and all procedures involved follow the standard of care. This is an observational study to provide clinical evidence in support of DBS effectiveness in the treatment of ET when delivered by the directSTIM DBS system. Twenty-one patients will be enrolled in this study. Subjects selected to participate in the study will be ET patients referred to uni- or bilateral DBS implant who meet the inclusion criteria and none of the exclusion criteria. Primary effectiveness variables will be measured at baseline for the identification of the worst limb (most affected by the disease), then 3 months post-surgery. Safety events will be collected between implant and 3-month visit, to evaluate potential confounding factors. After completing the 3-month visit, subjects will exit the study, and continue to be followed by their physician per usual care. Study will be conducted at minimum 3 centers in Europe.