相关临床试验
14
1 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
暂无试验阶段数据
进行中（未招募）
1
7.1%
已完成
9
64.3%
终止
3
21.4%
撤回
1
7.1%
暂无批准数据
- LivaNova's comprehensive CORE-VNS study of over 800 patients worldwide demonstrates sustained effectiveness of VNS Therapy for drug-resistant epilepsy over 36 months. - The study shows 77% median reduction in generalized tonic-clonic seizures at 24 months, with 43% of participants achieving complete seizure freedom. - VNS Therapy proved effective across age groups, with early seizure reduction observed at three months and benefits maintained throughout the study period. - The real-world evidence validates VNS Therapy as an effective adjunctive treatment for patients who have failed multiple anti-seizure medications.
- 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 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 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.
• Device-based therapies are increasingly integral in managing chronic heart failure, offering solutions for structural and neurohormonal abnormalities. • The FDA's Breakthrough Device Program expedites access to innovative heart failure devices, fostering development and evaluation of these therapies. • Recent approvals and novel therapies target structural or neurohormonal issues, complementing pharmacological treatments and filling gaps in unmet needs, such as HFpEF. • Approved devices include MitraClip for mitral regurgitation, Barostim neo for autonomic modulation, and the remedē System for central sleep apnea.
