PresentationRyan WeispfenningVP & Head of Investor Relations Okay. Hello, everyone. Thanks for joining us today. I'm Ryan Weispfenning, Vice President and Head of Investor Relations at Medtronic. Thank you for joining call showcasing the Altaviva device, which just secured FDA approval back on September 18. I want to remind everyone that today's event is being recorded, and a replay will be available on our website shortly after the call. A few quick announcements before we begin. Please note that today's c ...

PresentationRyan WeispfenningVP & Head of Investor Relations Okay. Hello, everyone. Thanks for joining us today. I'm Ryan Weispfenning, Vice President and Head of Investor Relations at Medtronic. Thank you for joining call showcasing the Altaviva device, which just secured FDA approval back on September 18. I want to remind everyone that today's event is being recorded, and a replay will be available on our website shortly after the call. A few quick announcements before we begin. Please note that today's c ...

Core Viewpoint - Medtronic's Altaviva device has received FDA approval as the first implantable tibial nerve stimulation device for treating overactive bladder (OAB), specifically urgency urinary incontinence (UUI), offering a new treatment option for millions of patients suffering from this condition [2][12]. Group 1: Technology and Clinical Features - The Altaviva device is implanted through a small incision at the ankle, making it a minimally invasive procedure that does not require sedation or imaging guidance, thus simplifying the operation [3]. - The device is approximately the size of half a piece of gum and is implanted just above the subcutaneous fascia, ensuring it does not interfere with daily activities [5]. - Compared to traditional therapies, Altaviva offers low invasiveness and long-term efficacy, emphasizing "no daily maintenance," which reduces the burden on patients [7]. Group 2: Clinical Trial Data - The approval of Medtronic's Altaviva is based on a series of clinical studies, including the TITAN 2 pivotal trial (NCT05226286) and the TITAN 1 feasibility study (NCT04873271) [8][9]. - The mechanism of action involves delivering electrical pulses to stimulate the tibial nerve, helping restore nerve signal transmission between the bladder and the brain, thereby improving bladder control [10]. - The core evidence for FDA approval included data from 188 UUI patients, showing that at 6 months post-implantation, at least 50% of patients experienced a reduction in UUI episodes [11]. - Safety data reported five adverse events related to the device or procedure, with one severe case requiring device removal after six weeks [11]. Group 3: Market Overview - Urinary incontinence is a widespread health issue globally, significantly impacting patients' quality of life, with over 25 million adults in the U.S. affected, particularly women over 50 [13]. - The global urinary incontinence treatment device market was valued at approximately $3.1 to $3.8 billion in 2023, projected to reach $6 to $6.5 billion by 2032, with a compound annual growth rate (CAGR) of 8% to 11% [13]. - Sacral nerve stimulation (SNS) is currently the most common implantable therapy in this field, with a market size of around $1.6 billion in 2023, expected to grow at a CAGR exceeding 11% by 2030, particularly in the Asia-Pacific region [13]. Group 4: Product Structure and Regional Market - Among various treatment options, the urethral sling represents the largest revenue-generating product category, with a market size exceeding $1.5 billion in 2023 [14]. - The U.S. remains the largest single market for urinary incontinence treatments, projected to reach approximately $3.78 billion by 2025, while the Chinese market is also growing rapidly, expected to reach about $380 million by 2025, with a similar CAGR of around 11% [14]. Group 5: Industry Trends - The launch of Medtronic's Altaviva device reflects a shift in the urinary incontinence treatment landscape, moving from traditional sacral nerve stimulation to more targeted and compact implantable solutions, indicating a growing demand for "minimally invasive, long-lasting, and high-compliance" treatments [16]. - The significant unmet treatment needs among the large population of urinary incontinence patients are driving accelerated investments in this field, with Altaviva's approval reinforcing Medtronic's leadership in nerve modulation and setting a new direction for product iteration in the industry [16].