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LivaNova Launches RECOVER Trial Of VNS For Depression To Meet CMS CED Requirement

 
• By Reed Miller

LivaNova's RECOVER trial will randomize about 1,000 patients with treatment-resistant depression to either LivaNova’s vagus nerve stimulation therapy or a sham therapy and follow them for at least a year.

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• Source: LivaNova PLC

LivaNova PLC is sponsoring the RECOVER trial to allow Medicare patients with treatment-resistant depression to receive LivaNova’s VNS Therapy vagus nerve stimulation system in a clinical trial that meets the requirements of a Coverage with Evidence Development, established last month, by the US Centers for Medicare and Medicaid Services.

On February 15, CMS announced that it will cover FDA-approved vagus nerve stimulation (VNS) devices for treatment-resistant depression through Coverage with Evidence Development 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 after that trial has demonstrated “positive interim findings

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