Vagus Nerve Stimulation Shows Promise for Treatment-Resistant Depression
• A large-scale clinical trial reveals that vagus nerve stimulation (VNS) can significantly improve depressive symptoms, quality of life, and daily functioning in individuals with severe, treatment-resistant depression.
• The study, involving nearly 500 participants, showed that VNS therapy led to measurable improvements, even in patients who had previously failed multiple treatments.
• VNS delivers focused stimulation to mood-regulating brain regions and can be used alongside other treatments, offering sustained relief for those who do not fully respond to antidepressants or therapy.
• The RECOVER trial aims to provide data that could lead to health insurance coverage for VNS, making it more accessible for patients with treatment-resistant depression.
Livanova's Aura6000 Meets Endpoints in Sleep Apnea Implant Trial
• Livanova's aura6000 hypoglossal nerve stimulator met primary safety and efficacy endpoints in a randomized trial for obstructive sleep apnea (OSA).
• The trial demonstrated improvements in OSA severity and blood oxygen levels after six months of treatment with the aura6000 device.
• Livanova plans to file for premarket approval with the FDA after completing data analysis from the seven-month follow-up visits.
• Analysts suggest that while the data looks promising, Livanova may face challenges entering the competitive sleep apnea market.
LivaNova's Aura6000 System Shows Promise in Obstructive Sleep Apnea Trial
• LivaNova's OSPREY trial met primary safety and efficacy endpoints for the aura6000 system, an implantable device for moderate to severe obstructive sleep apnea.
• The study demonstrated a 66.2% reduction in the apnea-hypopnea index and a 63.3% reduction in the oxygen desaturation index after six months.
• No serious device- or procedure-related adverse events were reported, supporting the safety profile of the aura6000 system.
• LivaNova plans to submit the OSPREY data to the FDA for premarket approval, with 12-month data expected in the first half of 2025.
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