Inspire Medical Systems

激励医疗系统

(NYSE: INSP)

（纽约证券交易所：INSP）

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announced today that its Inspire therapy has secured its CE mark under the EU’s Medical Device Regulation.

今天宣布，其Inspire therapy已根据欧盟医疗器械法规获得CE标志。

Going into effect in 2021, the tighter regulations in the European Union have been a major challenge for medical device companies. With worries growing that medtech companies would pull products out of the EU because of their inability to comply on time with the MDR, the EU’s government approved extending deadlines to get device designs and quality systems certified to as late as 2028 for some devices..

欧盟更严格的法规将于2021年生效，这对医疗器械公司来说是一个重大挑战。随着人们越来越担心医疗技术公司因无法按时遵守MDR而将产品撤出欧盟，欧盟政府批准将某些设备的设备设计和质量体系认证截止日期延长至2028年。。

“The scale of this transition to a new regulatory framework has proven to be a challenge for medical device manufacturers and the notified bodies who certify them. Given that, Inspire is pleased to reach this critical milestone,” Andreas Henke, Inspire’s EVP and managing director in Europe, said in a news release..

Inspire欧洲执行总裁兼董事总经理安德烈亚斯·亨克（AndreasHenke）在新闻稿中表示：“事实证明，向新监管框架过渡的规模对医疗器械制造商和认证机构来说是一个挑战。鉴于此，Inspire很高兴达到这一关键里程碑。”。。

The company’s implantable sleep apnea treatment device has had uninterrupted CE mark approval since 2020. The pacemaker-like neuromodulation device delivers mild electrical stimulation to the hypoglossal nerve, which controls tongue muscles.

自2020年以来，该公司的植入式睡眠呼吸暂停治疗装置已获得不间断的CE标志批准。这种类似起搏器的神经调节装置向控制舌肌的舌下神经提供轻微的电刺激。

“The Inspire team has worked diligently with our notified body in Europe to complete the review process, which included obtaining temporary approval through derogation authorization to continue to deliver Inspire product in several countries,” said Inspire CEO Tim Herbert.

Inspire首席执行官蒂姆·赫伯特（TimHerbert）表示：“Inspire团队与我们在欧洲的公告机构共同努力，完成了审查过程，其中包括通过克减授权获得临时批准，继续在多个国家交付Inspire产品。”。

There are two changes to Inspire therapy that are now CE marked under the EU MDR, that were not previously certified under the Active Implantable Medical Device Directive. First, patients in the EU may now undergo full-body MRI scans in the 1.5T MRI environment, provided the scans meet conditions in the company’s MRI guidelines manual.

激励治疗有两个变化，现在在欧盟MDR下被CE标记，以前没有根据主动植入式医疗器械指令进行认证。首先，欧盟患者现在可以在1.5T MRI环境中进行全身MRI扫描，前提是扫描符合公司MRI指南手册中的条件。

The MDR also provides a CEO mark for the present version of Inspire therapy’s leads with silicone insulation..

MDR还为目前版本的Inspire therapy导线提供了硅胶绝缘的CEO标志。。