Medtronic secures FDA approval for the Altaviva™ device, a simple experience for treating urge urinary incontinence
Medtronic (NYSE:MDT) has received FDA approval for its Altaviva™ device, a minimally invasive implantable tibial neuromodulation (ITNM) therapy for treating urge urinary incontinence. The device, implanted near the ankle without sedation or imaging, helps restore bladder-brain communication through electrical impulses to the tibial nerve.
The Altaviva device features a 15-year battery life, automatic therapy delivery, and MRI compatibility. It is designed to address a significant market, with 16 million Americans affected by urge urinary incontinence. This approval positions Medtronic as the only company offering a complete portfolio of neuromodulation therapies for bladder control issues.
Medtronic (NYSE:MDT) ha ottenuto l'approvazione FDA per il Altaviva™ dispositivo, una terapia di neuromodulazione tibiale implantabile minimamente invasiva (ITNM) per il trattamento dell'incontinenza urinaria da urgenza. Il dispositivo, impiantato vicino alla caviglia senza sedazione o imaging, aiuta a ripristinare la comunicazione tra vescica e cervello tramite impulsi elettrici al nervo tibiale.
Il dispositivo Altaviva presenta una batteria con durata di 15 anni, erogazione automatica della terapia e compatibilità con MRI. È progettato per rispondere a un mercato significativo, con 16 milioni di americani affetti da incontinenza urinaria da urgenza. Questa approvazione posiziona Medtronic come l'unica azienda a offrire un portfolio completo di terapie di neuromodulazione per i disturbi del controllo della vescica.
Medtronic (NYSE:MDT) ha obtenido la aprobación de la FDA para el Altaviva™ dispositivo, una terapia de neuromodulación tibial implantable mínimamente invasiva (ITNM) para tratar la incontinencia urinaria de urgencia. El dispositivo, implantado cerca del tobillo sin sedación ni imágenes, ayuda a restaurar la comunicación entre la vejiga y el cerebro mediante impulsos eléctricos al nervio tibial.
El dispositivo Altaviva cuenta con una vida de la batería de 15 años, entrega automática de la terapia y compatibilidad con MRI. Está diseñado para abordar un mercado significativo, con 16 millones de estadounidenses afectados por incontinencia urinaria de urgencia. Esta aprobación posiciona a Medtronic como la única empresa que ofrece un portafolio completo de terapias de neuromodulación para problemas de control de la vejiga.
Medtronic (NYSE:MDT)가 FDA의 승인을 받았으며 Altaviva™ 장치는 긴급성 요실금을 치료하기 위한 최소 침습적 이타뷸라 신경조절(ITNM) 치료법으로 임상적으로 사용됩니다. 이 장치는 발목 근처에 수술 없이 시술되며 진정제나 영상촬영 없이 뇌-방광 간의 소통을 다리의 tibial 신경으로 전기 자극을 통해 회복하도록 돕습니다.
Altaviva 장치는 15년의 배터리 수명, 자동 치료 전달 및 MRI 호환성을 특징으로 합니다. 급격한 필요성으로 인한 인구의 상당한 시장을 대상으로 하며, 1,600만 명의 미국인이 급성 요실금으로 영향을 받고 있습니다. 이 승인은 Medtronic을 방광 조절 문제에 대한 신경조절 치료 포트폴리오를 완전하게 제공하는 유일한 기업으로 위치시킵니다.
Medtronic (NYSE:MDT) a obtenu l'approbation FDA pour son dispositif Altaviva™, une thérapie de neuromodulation tibiale implantable peu invasive (ITNM) pour traiter l'incontinence urinaire d'urgence. L'appareil, implanté près de la cheville sans sédation ni imagerie, aide à restaurer la communication entre la vessie et le cerveau par des impulsions électriques vers le nerf tibial.
Le dispositif Altaviva présente une durée de vie de la batterie de 15 ans, une délivrance automatique de la thérapie et une compatibilité MRI. Il est conçu pour répondre à un marché important, avec 16 millions d'Américains touchés par l'incontinence urinaire d'urgence. Cette approbation place Medtronic comme la seule entreprise à offrir un portefeuille complet de thérapies de neuromodulation pour les troubles du contrôle de la vessie.
Medtronic (NYSE:MDT) hat die FDA-Zulassung für sein Altaviva™-Gerät erhalten, eine minimalinvasive implantierbare tibiale Neuromodulations-Therapie (ITNM) zur Behandlung der Dranginkontinenz. Das Gerät wird nahe dem Knöchel implantiert, ohne Sedierung oder Bildgebung, und hilft, die Blasen-Hirn-Kommunikation durch elektrische Impulse an den Tibialnerv wiederherzustellen.
Das Altaviva-Gerät verfügt über eine 15-jährige Batterielebensdauer, automatische Therapielieferung und MRI-Kompatibilität. Es richtet sich an einen bedeutenden Markt, mit 16 Millionen Amerikanern, die von Dranginkontinenz betroffen sind. Diese Zulassung positioniert Medtronic als das einzige Unternehmen, das ein vollständiges Portfolio an Neuromodulationstherapien für Blasenkontrollprobleme anbietet.
Medtronic (NYSE: MDT) قد حصلت على موافقة إدارة الغذاء والدواء الأمريكية على جهاز Altaviva™، وهو علاج تحفيز العصب tibial عبر زرع جراحي بسيط لعلاج سلس البول العاجل. يتم وضع الجهاز بالقرب من كاحل القدم بدون تخدير أو تصوير، ويساعد في استعادة التواصل بين المثانة والدماغ من خلال نبضات كهربائية إلى العصب tibial.
يتميز جهاز Altaviva بعمر بطارية يصل إلى 15 عاماً، وتوصيل العلاج تلقائياً، وتوافقه مع التصوير بالرنين المغناطيسي. وهو مصمم لاستهداف سوق كبير، حيث يعاني 16 مليون أمريكي من سلس البول العاجل. هذه الموافقة تضع Medtronic كشركة وحيدة تقدم مجموعة كاملة من علاجات التحفيز العصبي للتحكم في وظائف المثانة.
Medtronic（NYSE: MDT） 已获得 FDA 批准其 Altaviva™ 设备，这是一种用于治疗急迫性尿失禁的微创可植入胫骨神经调节（ITNM）治疗。该设备在踝部附近植入，无需镇静或影像，借助向胫神经的电脉冲来恢复膀胱与大脑之间的通信。
Altaviva 设备的电池寿命为 15 年，可自动提供治疗，且与 MRI 兼容。它面向一个重要市场，有 1600 万美国人受到急迫性尿失禁困扰。这一批准使 Medtronic 成为唯一提供完整膀胱控制神经调节治疗组合的公司。
- FDA approval secured for innovative urge urinary incontinence treatment device
- Device features long 15-year battery life with minimal maintenance requirements
- Addresses large market of 16 million potential patients in the US
- Minimally invasive procedure requires no sedation or imaging
- Makes Medtronic the only company with full neuromodulation therapy portfolio for bladder control
- Only 25% of people with bladder control issues discuss symptoms with doctors, indicating potential adoption challenges
Insights
Medtronic's FDA-approved Altaviva device for urinary incontinence expands their market leadership with innovative features addressing 16M potential patients.
Medtronic has secured a significant FDA approval for Altaviva™, their new implantable tibial neuromodulation (ITNM) device targeting urge urinary incontinence, a condition affecting nearly 16 million Americans. This approval strengthens Medtronic's position as the only company offering a complete portfolio of neuromodulation therapies for bladder control issues.
The Altaviva device offers several competitive advantages in this growing market. It features an impressive 15-year battery life under expected settings, eliminating the need for frequent replacements that plague competing products. The device is MRI-compatible, addressing a key limitation in earlier neuromodulation solutions, and provides automatic therapy delivery without requiring patient adjustments.
What makes this particularly valuable is the minimally invasive procedure that doesn't require sedation or imaging, significantly lowering the barriers to adoption compared to more complex implantable devices. The ankle placement and size (approximately half a stick of gum) make it less intimidating for patients who might otherwise avoid treatment.
This approval expands Medtronic's addressable market in a condition with high unmet need – despite affecting 43 million U.S. adults with bladder control problems, only 25% have discussed symptoms with doctors. By offering a solution that activates immediately and requires minimal maintenance (30-minute recharging sessions), Medtronic is positioning itself to capture significant market share in this underserved therapeutic area.
The economic implications of Medtronic's Altaviva device approval are substantial. Urinary incontinence represents a major economic burden for both patients and healthcare systems, with direct costs including continence pads, medications, and indirect costs from reduced productivity and quality of life impairments.
The market opportunity is significant - with 16 million Americans suffering from urge urinary incontinence but only a quarter discussing symptoms with physicians, there's substantial room for market expansion. Medtronic's strategy of offering a minimally invasive option fits perfectly into the trend toward value-based healthcare, potentially reducing downstream costs from complications or untreated symptoms.
The device's 15-year battery life creates a compelling economic proposition compared to alternatives requiring more frequent replacement procedures. Each avoided replacement surgery represents thousands in saved healthcare costs and reduced patient burden. Similarly, the MRI compatibility eliminates expenses associated with device removal/replacement when imaging is needed.
For Medtronic's business model, this creates a dual revenue stream: initial device sales followed by ongoing service revenue throughout the product lifecycle. As the only company with a full neuromodulation portfolio for this condition, Medtronic can leverage cross-selling opportunities across their product lines, potentially capturing patients at different stages of treatment escalation.
By addressing a condition with significant quality-of-life impact but historical undertreatment, Medtronic has positioned itself to benefit from increased diagnosis rates while delivering meaningful economic value to healthcare systems seeking to reduce the substantial costs associated with untreated incontinence.
The Implantable Tibial Neuromodulation (ITNM) device will expand treatment options for the 16 million people living with urinary urges and involuntary leaks
GALWAY,
Bladder control problems affect an estimated 43 million – or one in six –
"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. Kevin Benson, 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."
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. It sends electrical impulses to the tibial nerve, helping restore communication between the bladder and the brain to regulate bladder control.
"It's an honor to bring the Altaviva device to market," said Emily Elswick, 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."
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. Designed for real-life needs, the Altaviva device is MRI-compatible, providing patients with peace of mind for planned or unexpected medical imaging.
"Too many people silently struggle with the challenges of urgency and loss of bladder control, often believing that relying on diapers or pads is their only option," said Brett Wall, 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."
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.
Medtronic will host an investor call featuring Emily Elswick, General Manager of the Pelvic Health business, to discuss the Altaviva™ device and its impact on the treatment landscape for urge urinary incontinence on October 9, 2025 at 10am CST. A live webcast of this call will be available to the public on Medtronic's Investor Relations website.
About Medtronic
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Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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SOURCE Medtronic plc
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