LivaNova's (LIVN) Study To Evaluate VNS Therapy Gets CMS Nod
Zacks Investment Research | Sep 08, 2019 09:11PM ET
LivaNova PLC (NASDAQ:LIVN) has announced that it received the approval of the United States Centers for Medicare & Medicaid Services (“CMS”) for its protocol for RECOVER study on vagus nerve stimulation (VNS). RECOVER is a multi-center, randomized controlled blinded trial that demonstrates the safety and effectiveness of VNS Therapy System as adjunctive therapy compared with a no stimulation control in patients with Treatment-Resistant Depression (TRD).
As a breakthrough for LivaNova, in February this year, the CMS modified the National Coverage Determination (NCD) from non-coverage to a Coverage with Evidence Development (CED) framework in which CMS will cover the LivaNova Vagus Nerve Stimulation Therapy (VNS Therapy) for patients registered for the approved study. Apart from this, CMS will also cover device replacement for patients with a VNS Therapy device for TRD.
As the study protocol has been finalized, the company will now be ready to activate the sites, where the patients can enroll themselves and be part of the study. With this approval, LivaNova expects to improve its foothold in the global VNS market.
Significance of the Access
There are people around, who are suffering from depression that is difficult to treat. The study mainly aims to provide such people access to a potentially life-altering treatment option. Per management, depression is considered to be the leading cause of disability in the United States at present and given this scenario, this nod has come at just the right time.
The main feature of RECOVER is that it is a double-blind, randomized, placebo-controlled study, with a follow-up duration of at least one year. The CED also includes the possibility of extending the study to a prospective longitudinal study.
The enrollment program will likely start later in 2019 and, include up to 500 unipolar and bipolar patients each at maximum 100 sites in the United States.
How is This Superior to Traditional VNS Therapy?
Over time, VNS Therapy for TRD has proved highly effective and has helped improve response and remission rates significantly when used as a supplementary therapy. With the approval, the company aims to use this study to learn more about the effectiveness of VNS for TRD. Also, it aims to reach out to more patients, who are in dire needs of better treatment.
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The company expects to retain the positive momentum, which it already created while the enrollment and study will take some time to make further positive impact.
Industry Prospects
Per a report by Zacks Investment Research
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