LivaNova宣布 CORE-VNS 24个月数据显示，辅助性迷走神经刺激（VNS）治疗与耐药性癫痫患者的全身性强直-阵挛性发作显著减少相关-动脉网

LivaNova Announces CORE-VNS 24-Month Data Show Adjunctive VNS Therapy is Associated with Substantial Reductions in Generalized Tonic-Clonic Seizures in People with Drug-Resistant Epilepsy

会上厂商等信源发布 2025-06-05 20:08

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This is the latest prospective evaluation of VNS Therapy in generalized tonic-clonic seizures

这是最新的关于VNS疗法在全面性强直-阵挛性癫痫发作中的前瞻性评估。

Findings include 77% median seizure reduction and 43% of participants reporting seizure freedom at 24-month visits

研究结果包括发作中位数减少77%，并且43%的参与者在24个月的随访中报告无发作。

LONDON

伦敦

--(BUSINESS WIRE)--Jun. 5, 2025--

--（商业资讯）--2025年6月5日--

LivaNova PLC

理瓦诺瓦公共有限公司

(Nasdaq: LIVN), a market-leading medical technology company, today announced that 24-month data on generalized tonic-clonic (GTC) seizures in people with drug-resistant epilepsy (DRE) from the

(Nasdaq: LIVN)，一家市场领先的医疗技术公司，今天宣布了来自药物难治性癫痫（DRE）患者的强直-阵挛（GTC）发作的24个月数据。

CORE-VNS three-year study

CORE-VNS三年研究

have been published in

已在

Epilepsia

癫痫

。

Several CORE-VNS study findings were highlighted in the recent article on GTC seizures in DRE patients who received VNS Therapy™, including:

最近一篇关于接受VNS治疗™的DRE患者GTC发作的文章中强调了多项CORE-VNS研究结果，其中包括：

At 12 months, the median reduction in GTC seizure frequency was 74%, and this reduction was sustained through 24 months with a median reduction increasing to 77%.

在12个月时，GTC发作频率的中位减少率为74%，这种减少持续到24个月，中位减少率增加到77%。

Freedom from GTC seizures (defined as the absence of GTC seizures in the three months prior to the study visit) was reported by 37% and 43% of people at the 12- and 24-month study visits, respectively, despite people having a median 10-year duration of epilepsy.

尽管患者的癫痫中位持续时间为10年，但在12个月和24个月的研究访视中，分别有37%和43%的患者报告了无GTC发作（定义为研究访视前的三个月内无GTC发作）。

Approximately half of those experiencing GTC seizures were under 18 years of age, and nearly all (94%) had no history of any other previous surgery for epilepsy.

大约一半的全面性强直-阵挛（GTC）发作患者年龄小于18岁，且几乎所有人（94%）之前没有任何其他癫痫手术史。

GTC seizure reduction was seen early, with a median 52% reduction in GTC seizure frequency at the three-month study visit.

早在三个月的研究访问时就观察到GTC发作减少，GTC发作频率中位数减少了52%。

“GTC seizures can be some of the most severe and debilitating seizures a patient can experience,” said

“GTC发作可以是患者所能经历的最严重和最衰弱的发作之一，”

Ana Suller Marti

安娜·苏勒·马蒂

, M.D., Assistant Professor of Neurology at

医学博士，神经学助理教授 tại

Western University

西方大学

在

London, Ontario, Canada

加拿大安大略省伦敦市

, and the lead author for this study. “The observed reductions in seizure frequency and severity, as well as the achievement of complete seizure freedom in some cases, are key findings that clinicians should be aware of.”

“, 也是这项研究的主要作者。“观察到的癫痫发作频率和严重程度的减少，以及在某些情况下实现完全无癫痫发作，是临床医生应该了解的关键发现。”

The CORE-VNS study evaluated comprehensive outcomes of real-world evidence for more than 800 epilepsy patients treated with VNS Therapy worldwide. The 115 people with drug-resistant epilepsy and generalized seizures at baseline in this analysis had a median of 10 years between epilepsy diagnosis and VNS Therapy implantation.

CORE-VNS 研究评估了全球超过 800 名接受 VNS 治疗的癫痫患者的真实世界证据综合结果。本分析中，115 名患有耐药性癫痫和全面性发作的患者在基线时，从癫痫诊断到 VNS 治疗植入的中位间隔时间为 10 年。

Additionally, 90% of this participant population were under 18 years of age at the time of diagnosis..

此外，90%的该患者群体在确诊时未满18岁。

“I am struck by the significant seizure burden carried by the people, many of whom are so young, in this real-world dataset. Participants in this study failed a median number of six anti-seizure medications—some even as high as 20—and had a median of four tonic-clonic seizures per month at baseline,” said .

“我被这份真实世界数据集中的人们所承受的巨大癫痫发作负担所震撼，其中许多人如此年轻。本研究的参与者平均尝试了六种抗癫痫药物失败——有些人甚至高达20种——在基线时每月平均发生四次强直-阵挛性癫痫发作，”研究人员表示。

Stephanie Bolton

斯蒂芬妮·博尔顿

，

LivaNova

丽瓦诺瓦

President, Global Epilepsy. “Our focus remains on contributing to the science of the treatment of epilepsy, working in partnership with physicians, and transparently communicating the latest scientific information available.”

总裁，全球癫痫部门。“我们的重点仍然是为癫痫治疗的科学发展做出贡献，与医生合作，并透明地传达最新的科学信息。”

CORE-VNS participants have been followed through the 36-month study interval, and

CORE-VNS 的参与者已经通过了 36 个月的研究间隔期，

LivaNova

丽娃诺瓦

is currently in the process of publishing 36-month study outcomes.

目前正在发布36个月研究结果的过程中。

About CORE-VNS

关于CORE-VNS

CORE-VNS is a real-world, long-term, open-label study focused on the outcomes of VNS Therapy™ in people diagnosed with drug-resistant epilepsy (DRE). Enrolling more than 800 people from 61 worldwide sites, the study is the most comprehensive assessment of the effectiveness of VNS Therapy to date.

CORE-VNS 是一项针对药物难治性癫痫（DRE）患者使用VNS疗法™效果的真实世界、长期、开放标签研究。该研究从全球61个地点招募了800多名患者，是迄今为止对VNS疗法有效性最全面的评估。

Adverse events in this published clinical trial were typical following placement of a VNS Therapy device. The most commonly reported adverse events among participants with GTCs were dysphonia, cough, neck/oropharyngeal pain, and general discomfort. See important safety information at

在此已发表的临床试验中，放置VNS治疗装置后的不良事件是典型的。全面性强直-阵挛发作（GTCs）参与者中最常报告的不良事件包括发声困难、咳嗽、颈部/口咽疼痛以及全身不适。请参阅重要的安全信息。

VNSTherapy.com/safety

VNSTherapy.com/安全性

。

About VNS Therapy™ for Epilepsy

关于VNS疗法™ 癫痫

VNS Therapy is clinically proven safe and effective as an add-on treatment to reduce the frequency of seizures in adults and children as young as 4 years old with drug-resistant epilepsy and partial onset seizures. It is a unique treatment approach developed for people with drug-resistant epilepsy—a condition that affects approximately one in three people with epilepsy.

VNS疗法被临床证实作为一种辅助治疗，可有效且安全地减少患有耐药性癫痫和部分发作性癫痫的成人及4岁以上儿童的癫痫发作频率。它是为耐药性癫痫患者开发的一种独特治疗方法——这种病症影响着大约三分之一的癫痫患者。

Unlike some other surgical treatment options for people with drug-resistant epilepsy, VNS Therapy implantation involves an outpatient procedure and does not require penetration of the skull. Outside .

与一些其他针对药物难治性癫痫患者的手术治疗选项不同，VNS疗法的植入是一个门诊手术，且不需要穿透颅骨。

the United States

美国

, the VNS Therapy indications for use may vary.

，VNS疗法的使用适应症可能会有所不同。

VNS Therapy has not been approved by the

VNS疗法尚未获得批准

U.S. Food and Drug Administration

美国食品药品监督管理局

(FDA) for use in primary generalized seizures, and the safety and effectiveness of VNS Therapy for the reduction of primary generalized seizures has not been established.

（FDA）批准用于全面性癫痫发作，而VNS治疗在减少全面性癫痫发作方面的安全性和有效性尚未确定。

The VNS Therapy system is contraindicated for use in patients with a bilateral or left cervical vagotomy.

VNS治疗系统禁用于双侧或左侧颈迷走神经切断术的患者。

Do not use shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (hereafter referred to as diathermy) on patients implanted with a VNS Therapy System.

请勿对植入VNS治疗系统的患者使用短波透热疗法、微波透热疗法或治疗性超声透热疗法（以下简称为透热疗法）。

VNS Therapy indications for use vary by geographic location. Consult your local labeling.

VNS疗法的使用适应症因地理位置而异。请查阅当地的标签说明。

VNS Therapy Global Physician Manuals

VNS疗法全球医生手册

。

For more information, visit

欲了解更多信息，请访问

VNSTherapy.com

。

References

参考文献

Suller Marti A, Verner R, Keezer M, et al. Reduction of generalized tonic-clonic seizures following vagus nerve stimulation therapy: CORE-VNS Study 24-month follow-up. Epilepsia. Published online

苏勒·马蒂 A，维尔纳 R，基泽 M，等。迷走神经刺激疗法后全身性强直-阵挛性癫痫发作的减少：CORE-VNS 研究 24 个月随访。《癫痫》杂志在线发表。

April 1, 2025

2025年4月1日

. doi:10.1111/epi.18371

About

关于

LivaNova

丽娃诺瓦

LivaNova PLC

丽娃诺瓦公共有限公司

is a global medical technology company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through medical technologies, delivering life-changing solutions in select neurological and cardiac conditions. Headquartered in

是一家全球医疗技术公司，拥有近五十年的经验，并始终致力于通过医疗技术为患者及其家人带来希望，在选定的神经和心脏疾病领域提供改变生活的解决方案。总部位于

London

伦敦

，

LivaNova

丽娃诺瓦

employs approximately 2,900 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals, and healthcare systems worldwide. For more information, please visit

雇用大约2900名员工，并在100多个国家开展业务，为全球患者、医疗专业人员和医疗系统提供服务。欲了解更多信息，请访问

www.livanova.com

。

Safe Harbor Statement

安全港声明

This news release contains “forward-looking statements” concerning the Company’s goals, beliefs, expectations, strategies, objectives, plans, underlying assumptions, and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding the CORE-VNS study or VNS Therapy.

本新闻稿包含有关公司目标、信念、期望、策略、目的、计划、潜在假设及其他不一定是基于历史事实的“前瞻性声明”。这些声明包括但不限于关于 CORE-VNS 研究或 VNS 疗法的声明。

Actual events may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of the Company’s most recent Annual Report on Form 10-K, as supplemented by any risk factors contained in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. .

实际事件可能与我们前瞻性陈述中所指出的有重大差异，原因包括公司最近一份年度报告 Form 10-K 第 1A 项中列出的因素，以及任何季度报告 Form 10-Q 和当前报告 Form 8-K 中补充的风险因素。

LivaNova

丽娃诺瓦

undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.

本新闻稿中的信息如有后续事件或情况发生，不承担更新义务。

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