LivaNova touts CMS trial clearance for vagus nerve depression treatment system

LivaNova (NSDQ:LIVN) said on Wednesday that the U.S. Centers for Medicare & Medicaid Services finalized a National Coverage Decision for LivaNova’s Vagus Nerve Stimulation Therapy for treating treatment-resistant depression. The London-based company said that the modified NCD will enable Medicare coverage for VNS therapy through the Coverage with Evidence Development framework when offered through a CMS-approved, double-blind, randomized, placebo-controlled trial with a follow-up of at least 1 year. “As part of our commitment to improving the lives of patients around the world, LivaNova requested that CMS formally reconsider coverage for VNS Therapy for Treatment-Resistant Depression. We applaud CMS for taking this considerable step to provide increased access to treatment through Coverage with Evidence Development. We are pleased that CMS has expanded the potential beneficiaries of this therapy by including patients with bipolar disorder, an important and underserved patient population. Further, CMS expanded its research questions to include response to treatment, providing a much better gauge of benefit in this very ill patient population. Overall, this decision will help the large number of people who suffer from TRD receive access to an affordable, potentially life-altering treatment option,” CEO Damien McDonald said in a press release. The change will also cover replacement of the VNS therapy device, LivaNova said, and includes the possibility to e...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Neurological LivaNova Source Type: news