Alwide® Plus为公司自主研发的手术配套产品，用于在经导管主动脉瓣植入术(TAVI)前扩张钙化的主动 脉瓣膜，降低在TAVI手术中进行瓣膜成形术的挑战性。其主要特点包括：超低顺应性可实现更精准的 球囊扩张，避免血管损伤;高爆破压性能可有效地扩开严重钙化部位，更好地应对患者高钙化的特征;快 速充盈╱回抽性能可最大限度地避免长时间血流阻断对于心功能的影响，减少起搏时间、降低手术风 险;及优异的抗刺破性能可确保术中球囊扩张的安全性，给术者带来更好的使用体验。Alwide® Plus于 2021年8月获得中国国家药品监督管理局批准后，已陆续获得十余个海外国家或地区的注册批准。 Alwide® Plus获得CE标志批准，将为欧洲TAVI手术提供更优化的治疗方案，不仅可为集团贡献海外收 入增量，并可促进VitaFlow Liberty®经导管主动脉瓣及可回收输送系统(VitaFlow Liberty®)在欧洲的商 业化进程，更可加速二者在全球其他国家的注册进程，进一步深化集团海外战略的实施。 心通医疗-B(02160)发布公告，Alwide® Plus心脏瓣膜球囊扩张导管(Alwide® Plus)已获得CE标志 ...

Core Viewpoint - The company has received CE mark approval for its Alwide Plus balloon dilation catheter, enhancing its product offerings in the transcatheter aortic valve implantation (TAVI) market in Europe [1][2]. Group 1: Product Features and Benefits - Alwide Plus is designed to expand calcified aortic valves prior to TAVI, reducing the challenges associated with valve shaping during the procedure [2]. - Key features include ultra-low compliance for precise balloon expansion, high burst pressure for effectively opening severely calcified areas, rapid filling and deflation to minimize blood flow interruption, and excellent puncture resistance for enhanced safety during the procedure [2]. Group 2: Market Impact and Strategic Importance - The CE mark approval will optimize treatment options for TAVI in Europe, contributing to increased overseas revenue for the company [2]. - Alwide Plus is the fourth self-developed product to receive CE mark approval, enriching the company's product matrix in the structural heart disease market in Europe [3]. - The approval demonstrates the company's leading technological reserves and R&D capabilities in the global structural heart disease medical device sector, enhancing its competitive edge in the international high-end medical device market [3].

智通财经APP讯，心通医疗-B(02160)发布公告，Alwide® Plus心脏瓣膜球囊扩张导管(Alwide® Plus)已 获得CE标志(表明欧洲经济区内所售产品符合健康、安全及环保标准的认证标志)批准。 Alwide® Plus为集团继VitaFlow Liberty®、AnchorMan®左心耳封堵器系统及其导引系统后第四款获得 CE标志批准的自主研发产品，丰富了公司在欧洲这一结构性心脏病领域重要市场的产品矩阵，再次展 示了集团在全球结构性心脏病医疗器械领域领先的技术储备和研发实力，以及全球化战略布局的前瞻 性，并可通过四款产品间的协同效应，互相促进各自的商业化进程，进一步增强公司在国际高端医疗器 械市场的综合竞争力。 Alwide® Plus为公司自主研发的手术配套产品，用于在经导管主动脉瓣植入术(TAVI)前扩张钙化的主动 脉瓣膜，降低在TAVI手术中进行瓣膜成形术的挑战性。其主要特点包括：超低顺应性可实现更精准的 球囊扩张，避免血管损伤;高爆破压性能可有效地扩开严重钙化部位，更好地应对患者高钙化的特征;快 速充盈╱回抽性能可最大限度地避免长时间血流阻断对于心功能的影响，减少起搏时间、降低手术风 ...