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延长DBS系统主动扫描时间,美敦力获FDA批准扩大MRI标签

Medtronic earns FDA approval for expanded MRI labeling, making its best-in-class MRI capability even stronger

美敦力 等信源发布 2024-08-21 01:42

可切换为仅中文


Medtronic plc, a global leader in healthcare technology, has received U.S. Food and Drug Administration (FDA) approval of its expanded MRI (magnetic resonance imaging) labeling for Medtronic Percept™ PC and Percept™ RC, as well as Medtronic Activa™ PC, RC and SC.

美敦力股份有限公司是医疗保健技术的全球领导者,已获得美国食品和药物管理局(FDA)批准,为美敦力Percept™PC和Percept™RC以及美敦力Activa™PC、RC和SC扩展MRI(磁共振成像)标签。

The MRI labeling approval, exclusive to Medtronic Deep Brain Stimulation (DBS) systems, allows additional active scan time for scans below specified B1+rms limits, increasing the options available for diagnostic and functional assessments. Medtronic was the first medical device innovator in the U.S. to offer full-body MR Conditional DBS systems for patients to have safe scans anywhere on the body under specific conditions††..

美敦力深部脑刺激(DBS)系统专有的MRI标签批准允许在低于指定B1+rms限制的扫描中增加额外的主动扫描时间,从而增加了可用于诊断和功能评估的选项。美敦力是美国第一家提供全身MR条件性DBS系统的医疗器械创新者,该系统可使患者在特定条件下对身体任何部位进行安全扫描。。

“We know that nearly 70 percent of all DBS-eligible patients are estimated to require an MRI as part of their essential care1,” said Ashwini Sharan, chief medical officer, Medtronic Neuromodulation, which is part of the Medtronic Neuroscience Portfolio. “Only Medtronic DBS systems can continue therapy ON in bipolar mode, under certain conditions, while a patient is having an MRI scan2-4.

美敦力神经调节公司(Medtronic Neuroscience Portfolio)首席医疗官阿什维尼·沙兰(AshwiniSharan)表示:“我们知道,在所有符合DBS条件的患者中,估计有近70%的患者需要进行MRI检查,作为其基本护理的一部分1。”。“在某些情况下,只有美敦力DBS系统才能在双极模式下继续治疗,而患者正在进行MRI扫描2-4。

The updated labeling to remove the 30-minute active scan restriction, along with the Medtronic exclusive 3T MRI capability, provides patients with truly uncomplicated MRI access.”.

更新的标签消除了30分钟主动扫描限制,以及美敦力独家3T MRI功能,为患者提供了真正简单的MRI访问。”。

“Patients with movement disorders have debilitating tremors that often impact their ability to physically engage in everyday moments, as well as medical treatments that require stillness like an MRI,” said Amaza Reitmeier, vice president and general manager of Medtronic Brain Modulation within the Neuromodulation business.

“运动障碍患者有令人衰弱的震颤,通常会影响他们在日常生活中的身体活动能力,以及需要像MRI这样静止的药物治疗,”神经调节业务美敦力大脑调节副总裁兼总经理Amaza Reitmeier说。

“This updated labeling is another example of our unwavering commitment to enabling personalized patient care, with the goal of many more patient lives transformed with DBS therapy.”.

“这次更新的标签是我们坚定不移地致力于实现个性化患者护理的另一个例子,目标是通过DBS治疗改变更多患者的生活。”。

Since 1987, Medtronic has served more than 180 thousand patients with movement disorders and other indications in more than 70 countries with its life-changing DBS therapy5. Medtronic is dedicated to continuous advancement, also recently announcing U.S. FDA approval for Asleep DBS.

自1987年以来,美敦力在70多个国家为18万多名运动障碍和其他适应症患者提供了改变生命的DBS治疗5。美敦力致力于不断进步,最近还宣布美国FDA批准睡眠DBS。

About Medtronic

关于美敦力

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries.

大胆思考。更大胆的行动。我们是美敦力。总部位于爱尔兰戈尔韦的美敦力公司是全球领先的医疗保健技术公司,通过寻找和寻找解决方案,大胆应对人类面临的最具挑战性的健康问题。我们的使命是减轻痛苦,恢复健康,延长生命,我们将150多个国家的95000多名充满激情的全球团队团结在一起。

Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day.

我们的技术和疗法治疗70种健康状况,包括心脏设备、手术机器人、胰岛素泵、手术工具、患者监测系统等。凭借我们丰富的知识、永不满足的好奇心以及帮助所有需要帮助的人的愿望,我们提供了创新技术,每秒钟、每小时、每天都在改变两个人的生活。

Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary..

随着我们增强洞察力驱动的护理、以人为本的体验以及为我们的世界带来更好的结果,对我们的期望会更高。在我们所做的每件事中,我们都在创造非凡的。。