LivaNova Announces Publication Detailing the Design of the RECOVER Clinical Study Evaluating VNS Therapy for Treatment-Resistant Depression
“VNS Therapy for treatment-resistant depression has proven to be a safe and effective adjunctive treatment that significantly improves patients’ response and remission rates in this chronically ill population that is difficult to treat,” said Dr.
Major Depressive Disorder (MDD) is a leading cause of disability, morbidity and mortality worldwide.2 Even after four adequate courses of antidepressant treatment, one in three patients are left with depressive symptoms that significantly impact their daily functioning.3 The objectives of the RECOVER study are to confirm, in a randomized controlled blinded trial, the outcomes previously observed and published in a large registry4 – that VNS Therapy has a significant positive effect on baseline depressive symptom severity for patients with treatment-resistant depression (TRD).
“Working with CMS, we designed RECOVER – the largest clinical study of its kind – to further evaluate and confirm the efficacy of VNS Therapy for TRD,” said
More information about the RECOVER study is available at ClinicalTrials.gov and at recovervns.com.
About VNS Therapy for Depression
The VNS Therapy System, Symmetry™, is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. Commonly reported side effects are hoarseness, shortness of breath, sore throat and coughing. Side effects typically only occur during stimulation and are less noticeable over time.
Safety information is available at symmetryvns.com.
About
For more information, please visit www.livanova.com.
Safe Harbor Statement
This news release contains “forward-looking statements” concerning our goals, beliefs, expectations, strategies, objectives, plans and underlying assumptions and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding VNS Therapy and our approach to treatment-resistant depression using VNS Therapy. Actual results may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of our Annual Report on Form 10-K for the year ended
References
1 |
|
2 |
Rush, Trivedi, Wisniewski et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006. |
3 |
Rush, Aaronson et al. Chronic Vagus Nerve Stimulation Significantly Improves Quality of Life in Treatment-Resistant Major Depression. J Clin Psychiatry. 2018. |
4 |
Aaronson ST, Sears P, Ruvuna F, et al. A 5-Year Observational Study of Patients With Treatment-Resistant Depression Treated With Vagus Nerve Stimulation or Treatment as Usual: Comparison of Response, Remission, and Suicidality [published correction appears in Am J Psychiatry. 2017 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20200707005134/en/
LivaNova PLC Investor Relations and Media Contacts
VP, Investor Relations
InvestorRelations@livanova.com
VP, Corporate Communications
Corporate.Communications@livanova.com
Source: