Source of the article:Heart NotCome;Editor: Seven Kites
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Recently, the Center for Medical Device Evaluation released the 2024 second batch of special review applications for innovative medical devices, includingAccuPulse MedicalAccuPulse Medical Technology Co.Ltd's Cardiac Pulsed Field Ablation System（AccuPulse Pulsed Electric Field Ablation System。
AccuPulseIndependently Developed Pulsed Field Ablation Technology (PFA), toAtrial Fibrillation AblationAs the entry point,Take the leadDevelopedHost Pulse Ablation System and Ablation Catheter, and successfully completed the enrollment of all subjects for the clinical trials in April 2023. It is currently in the 12-month postoperative long-term follow-up phase.The results of the interim analysis have alreadyMeet the criteria for early success set by the clinical protocol, demonstrating that the product has world-leading safety and efficacy.。
# AccuPulse Pulsed Electric Field Ablation System▲AccuPulse Pulsed Electric Field Ablation System(From official website)AccuPulse Pulsed Electric Field Ablation SystemAdoptBipolar Biphasic Design, canFocusing Energy on the Myocardium, reducing muscle contraction or tremor. It supports 10-channel electrode ablation, achievingMicrosecond-level Single Pulse AblationThe diameter of the catheter tip loop is adjustable, allowing it to accommodate pulmonary veins of different sizes.In April 2023, the AccuPulse Pulsed Electric Field Ablation System completed enrollment for all clinical studies.Expected to be launched in 2025 in synchronization with AccuPulse's self-developed cardiac three-dimensional mapping system.. According to the 2023 International Cardiovascular Device Conference: In clinical research,AccuPulse Achieved a 100% Immediate Success Rate, with an Average Operation Time of 50 Minutes, an Average Total Discharge Time of Only 30 Seconds, and an Average X-ray Fluoroscopy Time of Approximately 7 Minutes。As of April 2023, no device-related adverse events had occurred in the trial.Postoperative patients' quality of life significantly improved。All researchers were able to successfully complete the first surgery. There was no significant difference between the average operation time in the early stage of the trial and the later stage.Researchers can quickly master the application of the AccuPulse pulsed ablation system through a shorter learning curve.。# HeartPulsed Electric Field AblationPulsed Electric Field Ablation（pulsed field ablation, PFA) is also known asIrreversible ElectroporationIt refers to the application of high-voltage electrical pulses to the phospholipid bilayer of the cell membrane in a short period of time, leading to the formation of transmembrane potential and generating unstable electric potential.The cell membrane thereby sustains irreversible permeability damage., generating nanoscale pores, which then leads to changes in cell membrane permeability, disrupts the intracellular environmental homeostasis, and ultimately causesApoptosis, reachingNon-thermal AblationThe purpose.By using pulsed electric field ablation to "kill" the atrial muscle of the pulmonary vein vestibule, the electrical signals in the pulmonary vein are prevented from being transmitted outward, ultimately achieving the goal of eliminating atrial fibrillation.Compared with traditional radiofrequency ablation, pulsed electric field ablation can cause extensive myocardial injury without relying on catheter contact force, which is beneficial forAvoid causing damage to adjacent structures such as the esophagus, coronary artery, and phrenic nerve.，MoreoverFast ablation speed, significantly shortening the operation time.▲Schematic Diagram of Irreversible Electroporation# Pulse Electric Field Ablation Market OverviewAccording to Forst & Sullivan data, the number of patients with arrhythmia in China exceeds 70 million. Supraventricular tachycardia (SVT) and atrial fibrillation are common types of rapid arrhythmia in clinical practice. The prevalence rate of SVT in the population is approximately 0.23%. In 2020, the number of SVT patients in China was 3.273 million, and it is expected to increase to 3.483 million by 2024, with a CAGR of 1.6%.In 2021, the population of patients with atrial fibrillation in China was 11.846 million, and it is expected to reach 2The patient population will grow to 12.602 million in 2024., with a CAGR of 2.1%.▲Data source:Forst&SullivanCurrently, the potential of the electrophysiology market in China is enormous.The penetration rate of electrophysiological surgery is less than 1%., with immense room for development,Market share of Chinese brands is less than 10%.，There is enormous space for domestic substitution.。Due to the significant development potential of the pulsed electric field ablation sector, many multinational corporations (such as Boston Scientific, Johnson & Johnson, and Medtronic) have already started to develop related product pipelines; meanwhile,In ChinaThere are also quite a few companies(such as Jinjiang Electronics, Denovo Electrophysiology, HT Medical, and Hanyu Medicaletc.)Already inHas a layout in the pulsed electric field ablation field and has obtained product approval.In addition, newly established local companies (such as Xuanyu Medical, AccuPulse, and ZHOUlin Medical) are all committed to the research and development of pulsed electric field ablation products.From the perspective of细分领域,Companies such as Denuo EP, AccuPulse, HT Medical, Jinjiang Electronics, and Hanyu Medical have all invested in pulsed field ablation products within the cardiac electrophysiology sector.; Companies such as Nuosheng Medical, Eagle Taoli An Kang, and Sinowave Medical focus on the field of tumor ablation and already have related products approved for marketing; Raydiant Biotech has simultaneously developed multiple product lines in the fields of oncology, cardiac electrophysiology, and endocavitary ablation; AccuPulse and Z-Legend Medical will concentrate on developing pulsed electric field ablation devices for the fields of oncology and cardiac electrophysiology.AccuPulse Medical Technology Co., Ltd. (referred to as: "AccuPulse Medical Technology Co.Ltd was established in November 2020 and is committed to becoming an internationally leadingCardiac Electrophysiology FieldPlatform-based innovative technology companyThe core team comes from multinational companies such as Johnson & Johnson, GE, Acutus Medical, and Abbott. They have rich experience in the research and development, registration, and commercialization of cardiac electrophysiology medical devices and have received strong support from returned overseas scientists, well-known clinical experts, and venture capital institutions.AccuPulse has further expanded its layout3D Mapping and Navigation System and New Supporting Tools，Developing an Integrated Solution for Atrial Fibrillation Pulse Ablation Active Devices and Associated Consumables。
▲Photo of 3D Mapping Experiment (Source: Suzhou Industrial Park Science and Technology Investment Center)
This three-dimensional mapping system innovatively integrates an intelligent magnetic and electric dual positioning system, and will combine with the next-generation intracardiac echocardiography (ICE) function in the future to achieve ultrasound magnetic and electric triple positioning technology. This technology will be perfectly integrated with the pulsed ablation system, effectively eliminating clutter and noise problems, addressing the challenges of precise positioning and contact of pulsed ablation catheters, and is expected to improve surgical success rates, reduce operation time, and provide patients with a safer, more effective, and more accurate treatment experience.
Currently,3D Mapping System Completes Design Finalization, currently undergoing system validation, multiple animal experiments of various types have been completed.About to enter the type inspection phase, expected to meet with a wide range of doctors and patients in China this year.
As of the date of publication,AccuPulse Medical Technology Co., Ltd. has completed four rounds of financing, with the latest round taking place in February 2024.Nearly 200 Million Yuan in A+ Round Financing, co-led by the Shaoxing Binhai New Area Biomedical Industry Equity Investment Fund managed by Shengshi Investment and the Shanghai Biomedical Fund. The company's full financing rounds are as follows:Overseas Cardiovascular Devices:Products of Chinese Cardiovascular Companies:Editor-in-Chief | Zhao Qing Reviewed by | Yi He
