/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, announced today that it has received U.S. Food and Drug Administration (FDA) approval for the

/ -- 美敦力公司（纽约证券交易所代码：MDT），一家全球领先的医疗技术公司，今天宣布已获得美国食品和药物管理局（FDA）的批准，对于

Altaviva™ device.

阿尔塔维瓦™ 设备。

The minimally invasive implantable tibial neuromodulation (ITNM) therapy is inserted near the ankle and designed to treat urge urinary incontinence.

微创植入式胫神经调节（ITNM）疗法被植入踝关节附近，旨在治疗急迫性尿失禁。

Bladder control problems affect an estimated 43 million – or one in six – U.S. adults. Of those, nearly 16 million people have urge urinary incontinence, a common symptom of overactive bladder (OAB) characterized by a sudden, intense urge to urinate, often followed by involuntary leaks before reaching the bathroom.

膀胱控制问题影响着约 4300 万美国成年人，相当于每六人中就有一人受此困扰。其中，近 1600 万人患有急迫性尿失禁，这是膀胱过度活动症 (OAB) 的常见症状，其特征是突然且强烈的排尿欲望，常常在到达厕所之前出现无法控制的漏尿。

However, only a quarter of people with general bladder control issues have discussed their symptoms with a doctor. These conditions can affect quality of life, mental health, and sleep, while also posing a significant economic burden on both society and patients..

然而，只有四分之一的膀胱控制问题患者与医生讨论过他们的症状。这些问题会影响生活质量、心理健康和睡眠，同时也给社会和患者带来沉重的经济负担。

'The Altaviva device represents a significant advancement for patients with urge urinary incontinence who often weigh the invasiveness of a therapy and the potential side effects when considering treatment options,' said Dr.

“对于急迫性尿失禁患者来说，Altaviva设备代表了一项重大进步，这些患者在考虑治疗方案时常常会权衡治疗的侵入性和潜在副作用，”博士说道。

Kevin Benson

凯文·本森

, Urogynecologist at Sanford Health and investigator for the Altaviva device pivotal study (TITAN 2). 'I'm excited to offer my patients this simple experience and believe the Altaviva device has the potential to transform lives and bring new hope to more people.'

，桑福德健康中心的泌尿妇科医生，也是Altaviva设备关键研究（TITAN 2）的研究者。 “我很高兴能为我的患者提供这种简单的体验，并相信Altaviva设备有潜力改变生活，为更多人带来新的希望。”

Patients who receive an Altaviva device return home with therapy activated, a first among implantable tibial devices for urge urinary incontinence. The device is inserted near the ankle during a minimally invasive procedure that doesn't require sedation or imaging. Approximately half the length of a stick of chewing gum, the Altaviva device sits slightly below the skin and above the fascia.

接受Altaviva装置的患者回家时治疗已经启动，这是用于急迫性尿失禁的可植入胫骨装置中的首例。该装置在微创手术中插入脚踝附近，不需要镇静或成像。Altaviva装置长约半根口香糖，位于皮肤下方略高于筋膜的位置。

It sends electrical impulses to the tibial nerve, helping restore communication between the bladder and the brain to regulate bladder control.  .

它向胫神经发送电脉冲，帮助恢复膀胱和大脑之间的通信，以调节膀胱控制。

'It's an honor to bring the Altaviva device to market,' said

“将Altaviva设备推向市场是一种荣幸，”表示

Emily Elswick

艾米丽·埃尔斯威克

, president of the Pelvic Health business, which is part of the Neuroscience Portfolio at Medtronic. 'For too long, society has told people it is normal to eventually lose bladder control. We say, 'enough'. What is common does not mean it is normal. The Altaviva device is designed to provide a simple and effective experience to treat urge urinary incontinence, empowering patients with a technology that supports them in their daily lives and opens the door to renewed hope and improved quality of life.'.

，美敦力神经科学产品组合中骨盆健康业务的总裁。“长久以来，社会一直告诉人们最终会失去膀胱控制是正常的。我们说，‘够了’。普遍存在的现象并不意味着就是正常的。Altaviva设备旨在提供一种简单而有效的治疗急迫性尿失禁的体验，使患者能够使用一种在日常生活中支持他们的技术，为他们带来新的希望和生活质量的提升。”

The Altaviva device is designed to have a 15-year battery lifespan under expected therapy settings and delivers therapy automatically, requiring no daily intervention or manual adjustments from the patient. Recharging will take up to 30 minutes when using the default recharging speed, eliminating the need for daily at-home charging equipment.

Altaviva设备在预期的治疗设置下设计有15年的电池寿命，并自动提供治疗，不需要患者每天干预或手动调整。使用默认充电速度时，充电最多需要30分钟，从而消除了对日常家用充电设备的需求。

Designed for real-life needs, the Altaviva device is MRI-compatible, providing patients with peace of mind for planned or unexpected medical imaging..

专为现实生活需求而设计，Altaviva 设备兼容 MRI，为患者提供计划内或意外医疗成像的安心保障。

'Too many people silently struggle with the challenges of urgency and loss of bladder control, often believing that relying on diapers or pads

“太多人默默承受着紧迫感和膀胱失控的挑战，常常认为依赖尿布或护垫

is their only option

是他们唯一的选择

Brett Wall

布雷特·沃尔

, executive vice president and president of the Medtronic Neuroscience Portfolio. 'The Altaviva device represents a transformative milestone and ushers in a new bladder control therapy with advanced features. Medtronic has earned its position as the global leader in neuromodulation by consistently pushing the boundaries of innovation, and this FDA approval underscores our unwavering commitment to delivering therapies that truly change lives.'.

，执行副总裁兼美敦力神经科学产品组合总裁。“Altaviva设备代表了一个变革性的里程碑，开启了具有先进功能的新型膀胱控制疗法。美敦力通过不断突破创新边界，赢得了其在神经调节领域的全球领导地位，此次FDA的批准彰显了我们致力于提供真正改变生命的疗法的坚定承诺。”

For over 30 years, Medtronic neuromodulation devices have improved the lives of people with bladder control symptoms. With the introduction of the Altaviva device, Medtronic becomes the only company with a full portfolio of neuromodulation therapies for this condition.

三十多年来，美敦力的神经调节设备改善了膀胱控制症状患者的生活。随着Altaviva设备的推出，美敦力成为唯一一家拥有针对此病症的全系列神经调节疗法的公司。

Medtronic will host an investor call featuring

美敦力将举办一场投资者电话会议，特邀

Emily Elswick

艾米丽·埃尔斯威克

, General Manager of the Pelvic Health business, to discuss the Altaviva™ device and its impact on the treatment landscape for urge urinary incontinence on

骨盆健康业务总经理，讨论Altaviva™设备及其对急迫性尿失禁治疗领域的影响

About Medtronic

美敦力公司简介

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway,

大胆思考。更大胆的行动。我们是美敦力。美敦力公司，总部位于戈尔韦，

Ireland

爱尔兰

, 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.

是全球领先的医疗技术公司，勇于攻克人类面临的最严峻的健康问题，通过寻找和发现解决方案。我们的使命——减轻痛苦、恢复健康、延长生命——将遍布150多个国家的95,000多名充满热情的员工团结在一起。

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。凭借我们广泛的知识、无尽的好奇心和帮助所有需要帮助的人的愿望，我们提供了创新的技术，每秒、每小时、每一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 .

对我们有更多期待，因为我们赋予以洞察力为驱动的关怀，优先考虑人的体验，并为我们的世界带来更好的结果。在我们所做的每一件事中，我们都在创造非凡。欲了解有关美敦力（纽约证券交易所代码：MDT）的更多信息，请访问。