Columbus®三维心脏电生理标测系统

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获批上市!首款开放三维介电标测系统
思宇MedTech· 2025-05-21 08:16
Core Viewpoint - The article highlights the significant advancements in cardiac electrophysiology technology, particularly focusing on the launch of the StarTrek® system by Jianhu Medical, which represents a breakthrough in domestic electrophysiology solutions [2][8]. Group 1: Industry Overview - Atrial fibrillation (AF) is the most common arrhythmia, affecting nearly 20 million patients in China, yet the number of surgical procedures remains low compared to coronary interventions [7]. - The market for three-dimensional mapping technology has evolved significantly, with major players like Johnson & Johnson and Abbott dominating the field, creating a monopolistic environment [7][8]. Group 2: Product Introduction - The StarTrek® system is the first domestic open three-dimensional dielectric imaging mapping system, integrating imaging, mapping, navigation, and damage assessment [8][10]. - The system offers high precision with a positioning accuracy of 0.4 mm and stability of 0.1 mm, significantly reducing the time required for mapping compared to traditional methods [14]. Group 3: Clinical Performance - In clinical trials, the StarTrek® system demonstrated lower pain responses and no adverse events during procedures for drug-resistant paroxysmal atrial fibrillation [10]. - The system allows for real-time observation of myocardial conditions and damage assessment during ablation, enhancing the success rate of procedures [14]. Group 4: Company Background - Jianhu Medical was founded in 2021, led by a team with extensive experience from major medical device companies, focusing on integrated solutions for cardiac electrophysiology [31]. - The company has developed both three-dimensional dielectric mapping technology and nanosecond pulsed electric field ablation technology, positioning itself uniquely in the market [31]. Group 5: Competitive Landscape - Other notable players in the three-dimensional mapping system market include Boston Scientific, Medtronic, and Abbott, each with their own innovative products and technologies [16][18][20][23]. - The competitive landscape is characterized by continuous technological advancements and regulatory approvals, with several systems recently gaining market entry [22][25][27][29].
2025年中国电生理器械行业产业链图谱、产业环境、市场现状及未来趋势研判:心律失常患者早筛治疗率不断提升,国产电生理器械加速渗透市场[图]
Chan Ye Xin Xi Wang· 2025-05-19 01:01
Core Viewpoint - The electrophysiology device market in China is experiencing rapid growth due to an aging population, increasing prevalence of arrhythmias, improved early screening rates, and advancements in electrophysiological procedures, with the market expected to reach over 40 billion yuan by 2032 [1][10][21]. Industry Overview - Electrophysiology devices are used to monitor and study electrical activities in biological systems, widely applied in medical, research, and clinical diagnosis fields. Common products include ECG machines, EEG machines, EMG machines, and electrophysiological navigation systems [2][4]. Industry Environment - The number of patients with rapid arrhythmias in China is projected to reach 28.2 million by 2024, driving demand for treatment. Electrophysiological surgeries have become a primary treatment method due to their advantages such as minimal invasiveness and high safety [6][8]. Industry Status - The market size for electrophysiology devices in China has grown from 2.42 billion yuan in 2017 to 12.55 billion yuan in 2024. The surgical volume for electrophysiology has increased from 138,000 cases in 2017 to 456,000 cases in 2024, indicating significant growth potential [10][8]. Competitive Landscape - The market is dominated by foreign companies such as Johnson & Johnson, Abbott, and Medtronic, which hold a combined market share of over 64%. Domestic companies like Huatai Medical and MicroPort EP have a much smaller share, indicating a high concentration in the industry [12][14]. Key Enterprises - MicroPort EP focuses on innovative medical devices for electrophysiology and has achieved significant revenue growth, with a projected income of 413 million yuan in 2024, up 25.51% [17]. Huatai Medical, specializing in electrophysiology and interventional medical devices, expects a revenue of 440 million yuan in 2024, reflecting a 19.73% increase [19]. Development Trends 1. **Accelerated Domestic Substitution**: Domestic brands are gaining market share due to supportive policies and technological advancements, with MicroPort EP and Huatai Medical leading in key areas [21]. 2. **Technological Innovation**: The industry is moving towards smart and precise technologies, enhancing the performance of electrophysiology devices and expanding clinical applications [22]. 3. **Growing Market Demand**: The demand for electrophysiology devices is surging, particularly in grassroots healthcare and international markets, with significant growth in overseas revenues for domestic companies [23].
微电生理摘U后首份成绩单亮眼,三款自主研发产品已进入“绿色通道”
Zheng Quan Shi Bao Wang· 2025-05-05 07:36
Core Viewpoint - Microelectrophysiology (688351.SH) has demonstrated strong growth in Q1 2025, with significant increases in revenue and net profit, indicating robust performance and development potential in the electrophysiology market [1] Financial Performance - In Q1 2025, the company achieved revenue of 104 million yuan, a year-on-year increase of 16.77% - The net profit attributable to shareholders reached 17.87 million yuan, up 328.63% year-on-year - The net profit after deducting non-recurring items also turned positive, amounting to 12.56 million yuan [1] Product Development and Commercialization - The company has completed the commercialization of PFA and has three products in the "green channel" for expedited approval - By 2024, over 30 registered products have been developed around the Columbus® 3D cardiac electrophysiology mapping system, with more than 70,000 surgeries performed using the 3D ablation series [2] - The PulseMagic™ pressure pulse catheter has entered the "green channel" for special review, with approval expected in 2025 [2] Technological Advancements - The EasyEcho™ intracardiac ultrasound catheter has also entered the "green channel," marking a significant innovation in high-end interventional imaging - This product utilizes intracardiac echocardiography technology for real-time, high-quality imaging without radiation, enhancing surgical precision and safety [3] Market Expansion and Growth Potential - The cardiac electrophysiology market is expected to reach 15.73 billion yuan in China by 2025, driven by increasing patient numbers and improved clinical outcomes - The PFA technology is anticipated to create a market space of over 10 billion yuan, reflecting significant growth opportunities [4] - The company plans to submit registrations for additional products in 2025, including pressure pulse ablation catheters and intracardiac ultrasound catheters [4] Internationalization Efforts - The company has expanded its international presence, with its 3D surgery covering 21 countries by 2024, and over 1,000 overseas surgeries performed using its pressure monitoring magnetic navigation RF ablation catheter [5] - The company has received CE certification for its cryo mapping catheter and cryo ablation devices, with further certifications expected for its magnetic navigation RF ablation catheter and high-density mapping catheter [6] Market Outlook - The global electrophysiology device market is projected to reach $14.49 billion by 2025 and could further increase to $32.45 billion by 2032, indicating a strong growth trajectory for the industry [6]