LivaNova PLC initiated the process with the U.S. Centers for Medicare and Medicaid Services (CMS) to seek reconsideration of national Medicare coverage for VNS Therapy™ in unipolar patients with treatment-resistant depression (TRD). This formal request is supported by five recently published or accepted peer-reviewed articles featuring in-depth data analyses from the RECOVER study.
The company believes these articles satisfy the Coverage with Evidence Development (CED) requirement for publicly accessible results. The request also includes strong 24-month clinical outcomes from the RECOVER study's unipolar cohort, demonstrating substantial retention of benefits and durability of VNS Therapy over time.
New top-line 24-month data show that among patients who achieved clinically meaningful benefit at 12 months, the median durability of benefit was 81.3% at 24 months. The median rate of response increased from 40.2% at 12 months to 51.6% at 24 months. Additionally, in-depth analyses on suicidality showed an estimated 43% higher odds of achieving meaningful improvement in suicidal ideation symptoms versus the control arm as early as month three.
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