Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD)

VNS provides indirect modulation of brain activity through the stimulation of the vagus nerve. The vagus nerve, the tenth cranial nerve, has parasympathetic outflow that regulates the autonomic (involuntary) functions of heart rate and gastric acid secretion, and also includes the primary functions of sensation from the pharynx, muscles of the vocal cords, and swallowing. It is a nerve that carries both sensory and motor information to/from the brain.

On February 15, 2019 CMS issued an NCD that covers FDA approved vagus nerve stimulation (VNS) devices for treatment resistant depression (TRD) through Coverage with Evidence Development (CED) when offered in a CMS approved, double-blind, randomized, placebo-controlled trial with a follow-up duration of at least one year with the possibility of extending the study to a prospective longitudinal study when the CMS approved, double-blind, randomized placebo-controlled trial has completed enrollment, and there are positive interim findings.

Decision Memo

Clinical Study Approvals

Study Title: A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER)
Sponsor: LivaNova
ClinicalTrials.gov Number: NCT03887715
CMS Approval Date: 09/04/2019