Medtronic plc, a leader in healthcare technology, has announced the U.S. Food and Drug Administration (FDA) approval of its Percept RC Deep Brain Stimulation (DBS) system.

医疗保健技术的领导者美敦力公司宣布，美国食品和药物管理局（FDA）批准其Percept RC深部脑刺激（DBS）系统。

The rechargeable neurostimulator is the latest innovation in the Medtronic Percept family, which includes the Percept PC neurostimulator, BrainSense technology, and SenSight directional leads. The Percept family is a sensing-enabled DBS system that allows the physician to personalize treatment for patients with movement disorders such as Parkinson's disease, essential tremor, and dystonia as well as epilepsy.

可充电神经刺激器是美敦力Percept家族的最新创新，其中包括Percept PC神经刺激器、BrainSense技术和SenSight定向引线。Percept家族是一个感应功能的DBS系统，允许医生对帕金森氏病、原发性震颤、肌张力障碍和癫痫等运动障碍患者进行个性化治疗。

Over 11 million people in the U.S. are living with movement disorders1-2 and approximately 3.4 million with epilepsy3..

美国有1100多万人患有运动障碍1-2，约340万人患有癫痫3。。

Helping Control Debilitating Tremors

帮助控制衰弱的震颤

'Our DBS therapy with exclusive BrainSense technology can help control debilitating tremors for people living with Parkinson's, providing patients with the ability to physically engage in everyday moments – something many of us unintentionally take for granted,' said Amaza Reitmeier, vice president and general manager, Brain Modulation within the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic.

神经调节业务部门大脑调节副总裁兼总经理Amaza Reitmeier说：“我们的DBS疗法采用独家BrainSense技术，可以帮助帕金森氏症患者控制虚弱的震颤，为患者提供参与日常生活的能力，这是我们许多人无意中认为理所当然的事情。”，这是美敦力神经科学投资组合的一部分。

'We are transforming brain modulation through sensing-enabled DBS and will continue to drive therapy innovation with the goal of many more peoples' lives improved with Medtronic DBS therapy.'.

“我们正在通过感知DBS改变大脑调节，并将继续推动治疗创新，目标是通过美敦力DBS治疗改善更多人的生活。”。

About the Percept RC Deep Brain Stimulation System

关于Percept RC深部脑刺激系统

DBS uses a surgically implanted medical device, similar to a cardiac pacemaker. Medtronic Percept neurostimulators transmit electrical signals via slender wires to specific brain targets affected by debilitating neurological disorders like Parkinson's disease.

DBS使用手术植入的医疗设备，类似于心脏起搏器。美敦力感知神经刺激器通过细长的电线将电信号传输到特定的大脑目标，这些目标受到帕金森氏病等衰弱性神经疾病的影响。

Percept RC is the smallest and thinnest dual channel neurostimulator available for DBS. It is equipped with BrainSense technology that captures and records brain signals to provide insights that enable a healthcare provider to adapt and personalize therapy to a patient's evolving needs.

Percept RC是可用于DBS的最小和最薄的双通道神经刺激器。它配备了BrainSense技术，可以捕获和记录大脑信号，提供见解，使医疗保健提供者能够根据患者不断变化的需求调整和个性化治疗。

Unlike other rechargeable devices, the Percept RC battery offers at least 15 years of service life with consistent and fast recharge performance. Medtronic patented battery technology has less battery fade than other rechargeable devices for a more reliable, long-lasting battery.  Patients can experience rapid recharging from 10% to 90% full charge in less than an hour. .

与其他可充电设备不同，Percept RC电池的使用寿命至少为15年，充电性能稳定快速。美敦力专利电池技术比其他可充电设备的电池衰减更少，电池更可靠，寿命更长。患者可以在不到一小时的时间内快速充电，从10%到90%完全充电。。。

'While more data are needed, the sensing capability of this unique deep brain stimulation system allows me the potential to tune stimulation delivery to brain activity, which may be a way to personalize this therapy for Parkinson's disease in the future,' said Casey H. Halpern, M.D., Neurosurgeon and deep brain stimulation expert. .

神经外科医生、深部脑刺激专家凯西·哈尔伯恩（CaseyH.Halpern）医学博士说：“虽然需要更多数据，但这种独特的深部脑刺激系统的感知能力使我有可能将刺激传递调整到大脑活动，这可能是未来个性化帕金森病治疗的一种方法。”。。。

Nearly 70 percent of all DBS-eligible patients are estimated to require an MRI as part of their essential care4. Medtronic was the first in the United States to offer full-body MR Conditional DBS systems for patients to have safe scans anywhere on the body under specific conditions.

据估计，所有符合DBS条件的患者中，近70%需要进行MRI检查，作为其基本护理的一部分4。美敦力是美国第一家为患者提供全身MR条件性DBS系统的公司，以便患者在特定条件下对身体任何部位进行安全扫描。

Percept offers greater freedom and scan access for patients with 3T scans and best-in-class 1.5T MRI scan labeling5-7. Medtronic has the only DBS system that allows patients to have stimulation on in bipolar mode during an MRI5-7. In addition, the Percept neurostimulators are engineered to allow for future software updates designed for the Percept platform without a neurostimulator device exchange. .

Percept为3T扫描和一流的1.5T MRI扫描标签5-7的患者提供了更大的自由度和扫描权限。美敦力拥有唯一的DBS系统，允许患者在MRI5-7期间以双极模式进行刺激。此外，Percept神经刺激器的设计允许为Percept平台设计的未来软件更新，而无需神经刺激器设备交换。。。

'This new rechargeable neurostimulator technology provides me with insights into my patients' symptoms and can capture data even when they're outside of the clinic,' said Eleni Okeanis Vaou, M.D., FAAN, associate professor of neurology. 'Now I have a rechargeable DBS therapy option with sensing technology allowing me to track a patient's response to DBS and medications.

神经病学副教授、医学博士埃利尼·奥卡尼斯·沃乌（EleniOkanisVaou）说，这种新的可充电神经刺激技术为我提供了对患者症状的深入了解，即使他们不在诊所也能捕捉数据现在，我有了一个可充电的DBS治疗选项，它具有传感技术，可以跟踪患者对DBS和药物的反应。

I use this data to inform how to personalize and optimize patient therapy.' .

我使用这些数据来告知如何个性化和优化患者治疗。”。。

Percept RC is available immediately throughout the U.S., as well as via CE Mark approval in Europe and availability in Japan.

Percept RC可立即在美国各地提供，也可通过欧洲的CE标志批准和日本的供应。

References:

参考文献：

1. Statistics on Parkinson's. Parkinson's Disease Foundation Web site. https://www.parkinson.org/understanding-parkinsons/statistics. Accessed 11/1/23

1、帕金森病统计。帕金森病基金会网站。（笑声）https://www.parkinson.org/understanding-parkinsons/statistics.23年11月1日访问

2. Louis ED, Ferreira JJ.  How common is the most common adult movement disorder?  Update on the worldwide prevalence of essential tremor.  Mov Disord. 2010;25(5):534-541.

2.Louis ED，Ferreira JJ。最常见的成人运动障碍有多常见？全球原发性震颤流行的最新情况。Mov不一致。2010年；25（5）：534-541。

3. https://www.epilepsy.com Accessed 11/1/23

三https://www.epilepsy.com23年11月1日访问

4. Falowski S, Safriel Y, Ryan MP, Hargens L. The rate of magnetic resonance imaging in patients with deep brain stimulation. Stereotact Funct Neurosurg. 2016; 94(3):147-153

4.Falowski S，Safriel Y，Ryan MP，Hargens L.脑深部刺激患者的磁共振成像率。立体定向功能神经外科。2016年；94（3）：147-153

5. ImageReady™ MRI Guidelines for Boston Scientific Deep Brain Stimulation Systems — 92195369-01, accessed on 10/18/2023

5、图像就绪™ 波士顿科学脑深部刺激系统的MRI指南-92195369-01，于2023年10月18日访问

6. MRI Procedure Information for Abbott Medical™* MR Conditional Deep Brain Stimulation Systems —ARTEN600090482 A. Accessed on October 18, 2023.

雅培医疗的MRI程序信息™*MR条件性深部脑刺激系统-ARTEN600090482 A.于2023年10月18日访问。

7. MRI guidelines for Medtronic deep brain stimulation systems 37601 37602 37603 37612 B35200 B35300 — M929535A_a_092 https://manuals.medtronic.com/manuals/mri/region

美敦力脑深部刺激系统MRI指南37601 37602 37603 37612 B35200 B35300-M929535A\U a\U 092https://manuals.medtronic.com/manuals/mri/region

8. Medtronic data on file.

美敦力数据存档。