Core Viewpoint - The approval of the Aortic Arch Stent System by Xianjian Technology marks a significant advancement in the treatment of aortic diseases, particularly for Stanford type B aortic dissections, addressing a critical unmet medical need in the market [1][3][4]. Product Development Background - Aortic endovascular intervention has gained recognition among clinicians and is in a rapid development phase, with approximately 70% of aortic dissection cases involving the ascending aorta and aortic arch [3]. - The complexity of the aortic arch anatomy has historically posed challenges for endovascular treatment, particularly in reconstructing the three branch arteries [3]. - Xianjian Technology's Aortic Arch Stent System, designed for chimney and fenestration techniques, aims to provide effective treatment solutions for patients with aortic arch lesions [3][4]. Product Introduction - The Aortic Arch Stent System is a collaborative innovation between Professor Shuchang's team and Xianjian Technology, having entered the special approval process for innovative medical devices in October 2022 [4]. - The system consists of the Ankura™ Plus Aortic Arch Main Stent System and the CSkirt™ Aortic Arch Branch Stent System, designed to facilitate the creation of a "window" for blood flow during surgery [4][5]. Clinical Trial Data - The prospective, multi-center clinical trial for the Aortic Arch Stent System involved over 30 authoritative centers, with 10 cases completed in the First in Man (FIM) study showing no complications such as vascular rupture or death [9][10]. - The trial included 120 patients, achieving an immediate surgical success rate of 97.46% and a 12-month treatment success rate of 90.83% [10]. Competitors in the Market - Competitors include InnoVascular with the Quick Fenestrater system, which is also designed for aortic arch branch artery reconstruction [11]. - Other notable players include Huamai Technology, Medtronic, Gore, and JOTEC GmbH, each offering various stent systems with unique features and applications in aortic arch treatment [11][13][15][16]. Company Overview - Xianjian Technology, established in 1999 and listed on the Hong Kong Stock Exchange in 2011, focuses on the research, production, and sales of cardiovascular and peripheral vascular interventional medical devices [16]. - As of June 30, 2024, the company has achieved a high-quality patent portfolio with 2,198 patents and has had 15 products approved for the special review process by the National Medical Products Administration (NMPA) [16][20].