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

At a Glance:

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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