LONDON–(BUSINESS WIRE)–$LIVN–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, today announced the first patient enrolled in “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). The study will evaluate Vagus Nerve Stimulation Therapy (VNS Therapy) for Treatment-Resistant Depression (TRD) in accordance with the U.S. Centers for Medicare & Medicaid Services (CMS) National Coverage Determination as part of its Coverage with Evidence Development Program. The first patient was enrolled by Dr. Azfar Malik in St. Louis.
“Through the RECOVER study, we have the ability to help patients with TRD across the United States gain access to a potentially meaningful treatment option to improve depressive symptoms and their quality of life,” said Dr. Malik, President and Chief Medical Officer for CenterPointe Behavioural Health Systems; Chairman and Chief Executive Officer of Psych Care; and Clinical Associate Professor of Psychiatry at St. Louis University. “I have had positive results treating depressed patients with VNS Therapy in the past. I look forward to gaining a greater understanding of TRD and evaluating how patients respond to VNS Therapy as an adjunctive treatment during this study.”
The objectives of the RECOVER study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity. The study will include up to 500 unipolar and up to 500 bipolar patients at as many as 100 sites in the United States. RECOVER is a double-blind, randomized, placebo-controlled study with a follow-up duration of at least one year. The CMS study framework also includes the possibility to extend to a prospective longitudinal study.
“With the enrollment of the first patient in RECOVER, we are on a pathway to better address treatment for depression, which is the leading cause of disability in the U.S.,” said Damien McDonald, Chief Executive Officer of LivaNova. “We are committed to this journey and to the patients who seek and deserve better forms of treatment.”
While VNS Therapy received CE Mark in 2001 and U.S. Food and Drug Administration (FDA) approval in 2005 for the treatment of depression, earlier this month, the FDA approved Symmetry™ as the latest VNS Therapy System for Depression. 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.
“Symmetry is the first and only FDA-approved implantable device specifically designed for depression that is difficult to treat,” said Jonathan Walker, Vice President of Depression at LivaNova. “We are pleased that the latest model of our VNS Therapy System, Symmetry, is now available as an option for patients.”
More information about the RECOVER study protocol is available at ClinicalTrials.gov.
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 occur during stimulation and decrease over time.
Safety information is available on the VNS Therapy website.
LivaNova PLC is a global medical technology and innovation company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. LivaNova’s advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems. Headquartered in London, LivaNova has a presence in more than 100 countries worldwide. The Company currently employs approximately 4,000 employees. LivaNova operates as two businesses: Cardiovascular and Neuromodulation, with operating headquarters in Mirandola (Italy) and Houston (U.S.), respectively.
For more information, please visit www.livanova.com.
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LivaNova PLC Investor Relations and Media
Melissa Farina, +1 (281) 228-7262
Vice President, Investor Relations
Deanna Wilke, +1 (281) 727-2764
Director, Corporate Communications