LivaNova Receives Approval from U.S. Centers for Medicare & Medicaid Services for RECOVER Clinical Study
Study to evaluate VNS Therapy for Treatment-Resistant Depression in accordance with agency’s National Coverage Determination as part of its Coverage with Evidence Development Program
“Now that the RECOVER study protocol has been finalized, we are ready to activate sites that will enroll patients in this important study. Those who suffer from depression that is difficult to treat may gain access through this study to a potentially life-altering treatment option,” said
RECOVER is a double-blind, randomized, placebo-controlled study with a follow-up duration of at least one year. The CED also includes the possibility to extend the study to a prospective longitudinal study. Enrollment is expected to begin in late 2019 and will include up to 500 unipolar and up to 500 bipolar patients at a maximum of 100 sites in
“In previous studies, we have seen VNS Therapy for TRD be highly effective and significantly improve response and remission rates when used as an adjunctive therapy,” said Dr.
More information about the protocol will be available at ClinicalTrials.gov.
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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