LivaNova PLC ((LIVN)) announced an update on their ongoing clinical study.
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Study Overview: LivaNova PLC is conducting a global, multi-center observational study titled ‘A Global PRospective, Multi-cEnter, ObServational Post-markeT Study tO Assess shoRt, Mid and Long-term Effectiveness and Efficiency of VNS Therapy® as Adjunctive Therapy in reaL-world patIents With diFficult to Treat dEpression.’ The study aims to evaluate the short, mid, and long-term outcomes of Vagus Nerve Stimulation (VNS) Therapy in patients with treatment-resistant depression, highlighting its significance in addressing this challenging condition.
Intervention/Treatment: The study focuses on Vagal Nerve Simulation (VNS) Therapy, a device-based intervention designed to stimulate the vagus nerve. This therapy involves an implantable generator, lead, and an external programming system, intended to provide adjunctive treatment for patients with difficult-to-treat depression.
Study Design: This is an observational cohort study with a prospective time perspective. It does not involve random allocation or masking, focusing instead on real-world data collection over a five-year duration to assess the effectiveness of VNS Therapy.
Study Timeline: The study began on October 5, 2017, and is currently recruiting participants. The last update was submitted on June 19, 2025. These dates are crucial as they indicate the study’s progress and ongoing nature, providing investors with a timeline for potential results and market impact.
Market Implications: The ongoing study could significantly influence LivaNova’s stock performance by demonstrating the efficacy of VNS Therapy in a real-world setting, potentially enhancing investor confidence. As the therapy targets a niche market of treatment-resistant depression, successful outcomes could position LivaNova favorably against competitors in the medical device industry.
The study is ongoing, with further details available on the ClinicalTrials portal.