Core Viewpoint - Adagio Medical's vCLAS cryoablation system has received FDA breakthrough device designation, marking a significant regulatory milestone in the treatment of ventricular tachycardia (VT) [2][4][5] Group 1: vCLAS System Overview - The vCLAS system is designed to treat drug-resistant, recurrent, and persistent monomorphic ventricular tachycardia in patients with ischemic or non-ischemic structural heart disease [4][5] - It utilizes Adagio's proprietary ultra-low temperature cryoablation (ULTC) technology, which can create deeper and more durable lesions compared to traditional methods, potentially improving the safety and efficacy of VT ablation procedures [4][5][12] - The system consists of a cryoablation console and a vCLAS ablation catheter, which features a 15cm long distal ablation segment with eight 1mm electrodes for intracardiac electrogram recording and identification [7][9] Group 2: Market and Treatment Landscape - The incidence of VT varies among populations and is associated with various factors, including coronary artery disease and certain hereditary heart disease syndromes [6] - The VT treatment market has been growing rapidly, with traditional methods like drug therapy and radiofrequency ablation facing limitations in effectiveness and safety [6] - There is increasing demand for cryoablation technology, which offers advantages such as minimal trauma and quick recovery, leading to an expanding market size in the coming years [6] Group 3: Technological Innovations - Adagio Medical has developed unique technologies such as near-critical nitrogen (NCN) cryoablation, which addresses issues like liquid nitrogen volume expansion and allows for precise control of the ablation range and depth [13][16] - The ultra-low temperature cryoablation (ULTC) technology enables the creation of extensive and continuous lesions in both atria and ventricles during a single ablation cycle [17][19] - The pulse field cryoablation (PFCA) technology combines ULTC and pulse field ablation (PFA) in a single catheter, potentially revolutionizing cardiac treatment by preventing bubble formation and allowing for higher voltage operations [20][23] Group 4: Company Background - Adagio Medical, founded in 2011 and headquartered in California, focuses on developing and commercializing products for arrhythmia treatment using its proprietary ultra-low temperature cryoablation technology [35][36] - The company's product line includes the iCLAS system for atrial fibrillation and the vCLAS system for VT, with ongoing clinical trials and regulatory approvals in Europe and the U.S. [36]

它采用 Adagio 专有的 超低温冷冻消融（ ULTC ）技术 ，与传统方法相比，能够在心脏组织中形成更 深、更持久的损伤，从而有可能提高 VT 消融手术的安全性和有效性。 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 | 重磅亮点 合作伙伴征集：2025全球手术机器人大会 心未来 2025 年 4 月 17 日，冷冻消融设备制造公司 Adagio Medica l ( Nasdaq: ADGM) 宣布其 vCLAS 冻消 融系统 获得 FDA 授予的" 突破性设备 "称号，这是公司和心律失常治疗领域的一个重要监管里程碑。 vCLAS 冻消融系统旨在 治疗缺血性或非缺血性结构性心脏病 患者的 药物难治性、复发性、持续性单形 性 室性心动过速（ VT ） 。 目前， vCL AS 已在欧 洲和特定市场上市，但在美国仍处于研究阶段 ，等待关键的 FULCRUM-VT 研 究完成，该研究正在招募 206 名患者以支持未来的上市前批准申请。 此外， 2024 年 3 月， vCLAS 获得 CE 标志批准，用于治疗单形室性心动速。 2024 年 5 月，该产品 获得了 FDA 的研究设备豁免 (I ...