神经技术公司CorTec宣布FDA批准涉及闭环脑互换植入系统的研究设备豁免（IDE）申请-动脉网

FDA approves Investigational Device Exemption for Early Feasibility Study for rehabilitation of stroke patients using CorTec’s Closed-Loop Brain Interchange implant system.

BioSpace 等信源发布 2024-06-11 21:53

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CorTec has announced today that the US Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application by the University of Washington School of Medicine (UW) involving the closed-loop Brain Interchange Implant System. This clinical study will investigate a novel stroke rehabilitation treatment using cortical stimulation to enhance plasticity within the brain.

CorTec今天宣布，美国食品和药物管理局（FDA）已批准华盛顿大学医学院（UW）的研究性设备豁免（IDE）申请，涉及闭环大脑交换植入系统。这项临床研究将研究一种新的中风康复治疗方法，使用皮质刺激来增强大脑内的可塑性。

With the clearance of the Brain Interchange System for human use CorTec is prepared to serve clinicians and research groups with its advanced implant technology to investigate novel treatment options for neurological diseases..

随着人类大脑交换系统的清除，CorTec准备用其先进的植入技术为临床医生和研究小组服务，以研究神经系统疾病的新治疗选择。。

With the Brain Interchange System, CorTec aims to provide a fully implantable closed-loop Brain-Computer Interface (BCI) to clinicians for the investigation of therapies. According to CorTec CTO Dr. Martin Schuettler, this closed-loop functionality provides new possibilities for highly individualized treatments.

通过大脑交换系统，CorTec旨在为临床医生提供一个完全可植入的闭环脑-计算机接口（BCI），用于研究治疗方法。根据CorTec首席技术官Martin Schuettler博士的说法，这种闭环功能为高度个性化的治疗提供了新的可能性。

He states, 'The system is capable of interchanging information between biology and technology, between brain and computer. That's why we call it CorTec Brain Interchange. With our system, we are providing the technological tools that are needed to develop new therapies and brain-computer interface applications.'.

他说，“该系统能够在生物学和技术之间，大脑和计算机之间交换信息。这就是为什么我们称之为大脑皮层交换。通过我们的系统，我们正在提供开发新疗法和脑机接口应用程序所需的技术工具。”。

With FDA clearance secured, CorTec joins forces with partners in the USA to continue the development of novel therapies. The first IDE study1 involving the Brain Interchange System will be conducted in collaboration with one of the world’s leaders in the field, principle investigator professor Jeffrey G.

在获得FDA批准后，CorTec与美国的合作伙伴联手，继续开发新疗法。第一个涉及大脑交换系统的IDE研究1将与该领域的世界领导者之一，首席研究员JeffreyG教授合作进行。

Ojemann from the University of Washington School of Medicine in Seattle as well as Prof. Steven C. Cramer from the University of California Los Angeles and their respective teams. With funding by the US-American National Institutes of Health (NIH)2, the consortium aims at obtaining initial first-in-human safety data and at the development and evaluation of novel therapeutical rehabilitation approaches for upper limb impairment in stroke patients via direct cortical electrical stimulation delivered by the Brain Interchange System.

西雅图华盛顿大学医学院的Ojemann以及加州大学洛杉矶分校的Steven C.Cramer教授及其各自的团队。在美国国立卫生研究院（NIH）2的资助下，该联盟旨在获得人类安全数据的初步领先，并通过大脑交换系统提供的直接皮层电刺激开发和评估中风患者上肢损伤的新型治疗康复方法。

Enrollment of patients and the first implantation of the neural interfacing system are schedule for the third quarter of 2024..

患者登记和神经接口系统的首次植入计划于2024年第三季度进行。。

Assistant Professor Dr. Jeffrey Herron from University of Washington is a co-investigator of the NIH funded study and the engineering lead on the project. He explains the importance of the FDA approval for the upcoming IDE study: “In the United States, all studies involving devices which pose a significant risk require the approval by both the FDA and institutional review board prior to participant recruitment.

华盛顿大学助理教授杰弗里·赫伦博士是美国国立卫生研究院资助的这项研究的联合研究员，也是该项目的工程负责人。他解释了FDA批准即将进行的IDE研究的重要性：“在美国，所有涉及具有重大风险的设备的研究都需要在招募参与者之前获得FDA和机构审查委员会的批准。

The FDA review of Investigational Device Exemptions for significant risk device studies is a rigorous process involving the submission of extensive documentation by both UW, the research site, and CorTec, the device manufacturer. The FDA makes their determination for a specific study based upon the details of the study protocol, an extensive hazard analysis, and an in-depth evaluation of the manufacturer’s documents pertaining to the design and testing of the device to ensure that it will perform as needed for the study.

FDA对重大风险设备研究的研究设备豁免的审查是一个严格的过程，涉及研究网站UW和设备制造商CorTec提交大量文件。FDA根据研究方案的细节，广泛的危害分析以及对制造商有关设备设计和测试的文件的深入评估，确定了具体研究的决定，以确保其按照研究的需要进行。

The fact that UW and CorTec have now received this IDE approval from FDA is an absolutely critical milestone demonstrating a readiness to proceed towards participant recruitment for this study, pending local UW IRB approval.”.

事实上，UW和CorTec现在已经获得FDA的IDE批准，这是一个绝对关键的里程碑，表明在当地UW IRB批准之前，已经准备好进行这项研究的参与者招募。”。

CorTec’s CEO, Dr. Oliver Baertl adds, “We are very excited about the feedback from the FDA! This was an important first step for CorTec to support clinical research in the fast growing neuromodulation and Brain Computer Interface space. We foresee many more studies with our device. The first in human use will be the next milestone for our technology and our company.”.

CorTec的首席执行官Oliver Baertl博士补充道：“我们对FDA的反馈感到非常兴奋！这是CorTec在快速增长的神经调节和脑-计算机接口领域支持临床研究的重要的第一步。我们预计我们的设备将进行更多的研究。人类首次使用将成为我们技术和公司的下一个里程碑。”。

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Disclaimer: The research reported in this publication is supported by the National Institute Of Neurological Disorders And Stroke of the National Institutes of Health under Award Number UH3NS121565. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health..

免责声明：本出版物中报道的研究得到了美国国立卫生研究院国家神经疾病和中风研究所的支持，奖项编号为UH3NS121565。内容完全由作者负责，不一定代表美国国立卫生研究院的官方观点。。

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References:

参考文献：

[1] IDE Application reference G230003/A001

[1] IDE应用程序参考G23003/A001

[2] NIH Project 1UH3NS121565-01A1: ” Motor Recovery through Plasticity-Inducing Cortical Stimulation”, in response to RFA-NS-18-023: https://reporter.nih.gov/search/-xvTvG85Ukm-KXyunAWaJw/project-details/10357993

[2] NIH项目1UH3NS121565-01A1：“通过可塑性诱导皮层刺激进行运动恢复”，响应RFA-NS-18-023：https://reporter.nih.gov/search/-xvTvG85Ukm-KXyunAWaJw/project-details/10357993

About CorTec

关于CorTec

CorTec was founded in 2010 in Freiburg, Germany. CorTec offers high-quality neurotechnology to industry and clinics. CorTec is offering components and active systems that allow users in industry and clinic to explore new clinical applications and to develop Medical Devices for specific indications.

CorTec于2010年在德国弗莱堡成立。CorTec为工业和诊所提供高质量的神经技术。CorTec提供组件和主动系统，允许工业和临床用户探索新的临床应用，并开发针对特定适应症的医疗设备。

The heart of CorTec’s product portfolio is the Brain Interchange System, which is a fully implantable investigational device for both sensing and stimulating on 32 channels. The system is designed for discovery of novel therapies for the central nervous system and for the exploration of brain-computer interface applications..

CorTec产品组合的核心是大脑交换系统，它是一种完全植入式的研究设备，可在32个通道上进行感知和刺激。该系统旨在发现中枢神经系统的新疗法，并探索脑-计算机接口应用。。

On basis of the Brain Interchange CorTec also offers the Brain Interchange Evaluation Kit, which is a bench-top-version of the actual implant for testing and validation of your intended therapy. It is electrically identical to the implant and is therefore the ideal entrance to the clinical use of the brain interchange system..

在大脑交换的基础上，CorTec还提供了大脑交换评估工具包，这是一个台式版本的实际植入物，用于测试和验证您的预期治疗。它在电气上与植入物相同，因此是大脑交换系统临床应用的理想入口。。

Based on the Brain Interchange Technology, CorTec offers individualized solutions for components of active implants. The Brain Interchange System as well as each component can be individualized to meet indication specific requirements – as a system solution or single component design. CorTec is offering the °AirRay Electrode Technology, high-channel implant housing technology and other components/technologies as service to 3rd parties.

基于大脑交换技术，CorTec为主动植入物的组件提供个性化解决方案。大脑交换系统以及每个组件都可以个性化，以满足特定指示的要求-作为系统解决方案或单个组件设计。CorTec向第三方提供°AirRay电极技术、高通道植入物外壳技术和其他组件/技术。

CorTec provides its customers with individual systems and components to interface the central and peripheral nervous system..

CorTec为其客户提供单独的系统和组件，以连接中枢神经系统和周围神经系统。。

Contact:

联系人：

CorTec GmbH

Dr. Oliver Bärtl (CEO), Dr. Martin Schuettler (CTO)

Oliver Bärtl博士（首席执行官）、Martin Schuettler博士（首席技术官）

Neuer Messplatz 3

新测量站3

79108 Freiburg – Germany

79108德国弗莱堡