Medtronic today announced it received approval from the National Medical Products Administration (NMPA) in China for its Symplicity Spyral™ renal denervation (RDN) system, also known as the Symplicity™ blood pressure procedure. Symplicity Spyral is the first RDN system in China to receive NMPA approval.

美敦力今天宣布，其Symplicity Spyral™肾脏去神经支配（RDN）系统（也称为Symplicity™血压程序）已获得中国国家医疗产品管理局（NMPA）的批准。Symplicity Spyral是中国第一个获得NMPA批准的RDN系统。

The company intends to go through the provincial registration process and expects sales of Symplicity Spyral in China to be modest in the short-term..

该公司打算通过省级注册程序，预计Symplicity Spyral在中国的销售额短期内不会太大。

Hypertension is one of the most prominent public health challenges in China, with over 245 million people affected by the condition.1 Further, only 13.8% of those living with hypertension in China have their condition under control.2 Worldwide, control rates remain low, despite available medications and lifestyle interventions.

高血压是中国最突出的公共卫生挑战之一，超过2.45亿人受到这种疾病的影响。此外，中国只有13.8%的高血压患者的病情得到了控制。2尽管有可用的药物和生活方式干预措施，但在世界范围内，控制率仍然很低。

These challenges speak to the possibility that patients may benefit from an adjunctive treatment option to better manage their blood pressure..

这些挑战表明，患者可能会受益于辅助治疗选择，以更好地控制血压。。

This NMPA approval milestone comes shortly after Medtronic announced both the approval from the U.S. Food and Drug Administration for the Symplicity Spyral system as well as the launch of the technology in India and Canada. These achievements reinforce Medtronic’s commitment to expand global access to this technology for individuals with hypertension.

在美敦力宣布获得美国食品和药物管理局（FDA）对Symplicity Spyral系统的批准以及该技术在印度和加拿大的推出后不久，NMPA获得了这一里程碑式的批准。这些成就加强了美敦力致力于为高血压患者扩大全球使用该技术的机会。

The Symplicity Spyral system also recently received approval under the Greater Bay Area policy in China to commercially sell the system to hospitals in the Greater Bay Area..

根据中国大湾区政策，Symplicity Spyral系统最近也获得批准，将该系统商业销售给大湾区的医院。。

The Symplicity blood pressure procedure is an innovative, minimally invasive procedure that delivers radiofrequency energy to calm the nerves near the kidneys that can become overactive and cause elevated blood pressure.  After sedation, the doctor inserts a single thin tube (known as a catheter) into the artery leading to the kidney.

Symplicity血压程序是一种创新的微创程序，可提供射频能量，以平静肾脏附近可能过度活跃并导致血压升高的神经。镇静后，医生将一根细管（称为导管）插入通向肾脏的动脉。

Once the tube is in place, the doctor administers energy to the system to calm the excessive activity of the nerves connected to the kidney. The tube is removed, leaving no implant behind. .

一旦导管就位，医生就会向系统输送能量，以平息与肾脏相连的神经的过度活动。管子被移除，没有留下植入物。。

“As the leader in renal denervation, we are looking forward to bringing the Symplicity blood pressure procedure to China, where high blood pressure rates continue to increase,” said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic.

美敦力心血管投资组合的冠状动脉和肾脏去神经支配业务高级副总裁兼总裁杰森·魏德曼（JasonWeidman）表示：“作为肾脏去神经支配的领导者，我们期待着将Symplicity血压程序引入中国，那里的高血压率持续上升。”。

“As these rates continue to climb, the need for innovative, alternative treatments is strong. The Symplicity procedure can provide people in China with another potential option when seeking high blood pressure solutions, complementing lifestyle modifications and medication.”.

“随着这些比率持续攀升，对创新替代疗法的需求非常强烈。Symplicity程序可以为中国人提供另一种潜在的选择，以寻求高血压解决方案，补充生活方式的改变和药物治疗。”。

Data have shown that small blood pressure reductions significantly reduce cardiovascular risk. Decreasing blood pressure by 10 mmHg leads to a 20% relative risk reduction of major cardiovascular events.3

数据显示，血压的小幅下降可以显著降低心血管疾病的风险。血压降低10 mmHg导致主要心血管事件的相对风险降低20%。3

Symplicity Spyral, one of the most thoroughly tested cardiovascular interventional devices coming to market, is backed by experience in more than 25,000 patients globally.4 The procedure showed:

Symplicity Spyral是上市的经过最彻底测试的心血管介入设备之一，拥有全球25000多名患者的经验。4该程序显示：

Mean reduction in patients’ office-based systolic blood pressure (OSBP) of 9 mmHg at three months (OFF MED), 9.9 mmHg at six months (ON MED), and 18 mmHg (OSBP) at three years, with sustained blood pressure reductions in more than 1,500 patients. 5-11

患者基于办公室的收缩压（OSBP）在三个月时平均降低9 mmHg（OFF MED），六个月时平均降低9.9 mmHg（ON MED），三年时平均降低18 mmHg（OSBP），持续降低1500多名患者的血压。5-11页

Very low rates of adverse events, making for a safe procedure.5-11

不良事件发生率非常低，有利于安全操作

Symplicity also demonstrated improved blood pressure control with significantly more time in treatment range after radiofrequency RDN when compared to sham through three years. 12

与假手术相比，Symplicity还显示出改善的血压控制，射频RDN后治疗范围内的时间明显更长。12

Currently limited for investigational use in Japan, the Symplicity Spyral Renal Denervation System is approved for commercial use in more than 70 countries around the world.

Symplicity Spyral肾脏去神经支配系统目前仅限于日本的研究使用，已被批准在全球70多个国家商业使用。

About Medtronic

关于美敦力

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, 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 150 countries.

大胆思考。更大胆的行动。我们是美敦力。总部位于爱尔兰都柏林的美敦力公司（Medtronic plc）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，延长寿命，我们团结了150个国家的95000多名充满激情的全球团队。

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. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com and follow @Medtronic on LinkedIn..

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。有关美敦力（纽约证券交易所代码：MDT）的更多信息，请访问www.Medtronic.com并在LinkedIn上关注@Medtronic。