新华财经沈阳11月28日电（记者李宇佳）27日，由沈阳鹏悦科技有限公司自主研发的心脏冷冻消融系统在辽宁省沈抚改革创新示范区举行首台下线仪式。该 产品是辽宁沈抚示范区推进科技创新与产业创新深度融合、培育"低温冷冻医学"产业链的标杆成果，对推动辽宁省战略性新兴产业高端化、集群化发展具有 重要示范价值。 作为最常见的心律失常，房颤已成为全球性健康挑战，其中持续性、长程性房颤因病情复杂，长期依赖高难度的外科手术治疗。2020年起，沈阳鹏悦科技创 始团队与中国人民解放军北部战区总医院王辉山教授团队联合开展研发，攻克了"快速降温""主动复温"和"背侧温度反馈"等核心技术，首创氩气冷媒与氦气 热媒双气循环系统，实现心肌细胞精准消融的同时，最大限度保护心肌纤维骨架与周边神经血管。 （文章来源：新华财经） 历经近五年攻关，"鹏悦科技-冷冻消融系统"日前正式获得国家药品监督管理局批准创新医疗器械注册。该创新医疗设备具有主动复温、真空隔热、背侧温 度反馈等首创技术，获准用于成人心脏病患者持续性房颤治疗，填补了国内高端医疗装备领域空白，为持续性房颤患者带来诊疗新路径。 ...

Core Insights - The first unit of the cardiac cryoablation system developed by Shenyang Pengyue Technology Co., Ltd. has been officially launched, marking a significant advancement in the treatment of persistent atrial fibrillation in adult heart disease patients [1] - This innovative medical device is the first of its kind internationally to feature active rewarming, vacuum insulation, and backside temperature feedback technologies, filling a gap in the domestic high-end medical equipment sector and breaking the technological monopoly of foreign manufacturers in the field of surgical treatment for atrial fibrillation [1] Company Developments - The Pengyue Technology cryoablation system has received approval from the National Medical Products Administration for innovative medical device registration, enabling precise ablation of myocardial cells while maximizing the protection of myocardial fiber skeletons and surrounding nerve blood vessels [1] - The product is seen as a benchmark achievement in promoting the deep integration of technological innovation and industrial innovation within the Shenyang-Fushun Reform and Innovation Demonstration Zone, contributing to the development of a low-temperature cryogenic medical industry chain [1] Industry Impact - The introduction of this product is expected to demonstrate significant value in promoting the high-end and clustered development of strategic emerging industries [1]

Core Viewpoint - The world's first cardiac cryoablation system has been launched in the Shenyang-Fu Reform and Innovation Demonstration Zone, marking a significant advancement in the treatment of persistent atrial fibrillation and breaking the long-standing foreign monopoly in this field [1][3]. Group 1: Product Development - The cardiac cryoablation system features innovative technologies such as active rewarming, vacuum insulation, and backside temperature feedback, specifically designed for the surgical treatment of persistent atrial fibrillation in adult patients [1][3]. - The product was developed through a collaboration between Shenyang Pengyue Technology and the team led by Professor Wang Huishan from the Northern Theater Command General Hospital, overcoming key technical challenges over nearly five years [3][4]. - The system includes both the cryoablation device and disposable sterile cryoablation probes, which have recently received approval from the National Medical Products Administration [3]. Group 2: Industry Impact - The successful launch of this product represents a significant breakthrough in the high-end medical equipment sector in China and serves as a model for integrating medical and engineering fields, as well as for exploring new paths in industry-academia-research applications [3]. - This innovation is expected to enhance the development of the "low-temperature cryogenic medicine" industry chain and contribute to the high-end, clustered development of strategic emerging industries in Liaoning [3][4]. - The widespread adoption of this system is anticipated to optimize and upgrade maze surgical pathways, providing a safer, more efficient, and controllable treatment option for patients with persistent atrial fibrillation [4].

Core Points - The article highlights the approval of two innovative medical devices by Pengyue Technology, specifically a cardiac cryoablation device and a disposable sterile cryoablation probe, which are recognized as national-level innovative medical devices [1][2] - The provincial drug regulatory authority has been actively supporting the innovation of medical devices, optimizing the review and approval processes to accelerate the transformation of innovative results [2][3] - The new cardiac cryoablation system is expected to provide a safer, more efficient, and controllable treatment option for patients with persistent atrial fibrillation, with clinical trial results showing an 80% effectiveness rate in preventing recurrence six months post-surgery [2][3] Company Summary - Pengyue Technology has successfully developed a cardiac cryoablation system that addresses the limitations of traditional treatment methods and significantly reduces patient treatment costs [3] - The company formed a collaborative team to apply argon-helium cryogenic technology to surgical treatments, overcoming challenges related to cooling speed and rewarming processes [2] - The new products are set to be applied clinically in December, marking a significant advancement in the medical device industry [3] Industry Summary - The medical device industry in China is experiencing rapid growth, with the market size surpassing one trillion yuan [3] - The provincial drug regulatory authority plans to deepen reforms in drug regulation and support high-quality development in the pharmaceutical industry, aiming to benefit more companies from the regulatory changes [3]