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].

报名：首届全球眼科大会 | 议程更新 报名：首届全球骨科大会 | 议程更新 报名：首届全球心血管大会 | 奖项申报 合作伙伴征集：2025全球手术机器人大会 2025年3月26日，NMPA公布了创新医疗器械特别审查申请审查结果公示（2025年第3号），有 14款产品 进入创新通道。其中包括， 博睿康医疗科技（上海）有限 公司 申请的 植入式神经刺激系统 。 # 研究背景 随着全球老龄化加剧， 神经退行性疾病 （如帕金森病、癫痫等）的患病率不断攀升，植入式神经刺激系统的需求也日益增长。近年来，医疗技术的飞速发展显著提 升了植入式神经刺激系统的治疗效果与安全性，使其在慢性疼痛、抑郁症、帕金森病、癫痫、尿失禁、肌张力障碍等众多疾病的治疗中展现出广阔的应用前景。 植入式神经刺激系统 是一种通过电刺激神经系统来治疗疾病的医疗设备，通常由 电极、脉冲发生器和电池 等组成。它通过精确的电信号调节神经活动，从而改善或 恢复功能。根据不同的应用领域，植入式神经刺激系统可分为 脑深部刺激器、脊髓刺激器、迷走神经刺激器、骶神经刺激器、胃刺激器 等。 # 植入式神经刺激系统分类 脑深部刺激（DBS） 脑深部刺激是通过植入脑深部特定核 ...