Clinical Research Response: VNS Therapy (LivaNova Inc.) for Seizure Control



Technology VNS Therapy
Focus of Report The focus of this report is to assess the safety and effectiveness of the VNS Therapy System (LivaNova), a vagus nerve stimulation device for seizure control.
Literature Summary A search of the peer-reviewed literature yielded 15 abstracts examining the VNS Therapy System in patients with epilepsy. The study designs included a randomized controlled trial (RCT), a prospective comparative study, prospective uncontrolled studies, retrospective comparative studies, and retrospective uncontrolled studies.
Regulatory Status The VNS Therapy System received initial FDA Premarket Approval (PMA) (P970003) on July 16, 1997. A total of 216 supplemental approvals have been issued for this system since the original approval.
Viewpoint A review of peer-reviewed abstracts revealed widely variable results in patients using the VNS Therapy System with respect to reduction in seizure frequency, adverse events, and quality of life. Therefore, a conclusion regarding the overall clinical safety and effectiveness of the VNS Therapy System for the treatment of epilepsy was not possible.

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