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先健科技:主动脉弓支架系统获得中国国家药品监督管理局的正式注册批准
Zhi Tong Cai Jing· 2025-05-15 10:21
Core Viewpoint - The announcement highlights the approval of the aortic arch stent system by the National Medical Products Administration of China, marking a significant advancement in the treatment of Stanford type B aortic dissection patients through innovative technology [1][2] Group 1: Product Approval and Features - The aortic arch stent system is the first of its kind approved for the specific use of windowing technology in aortic arch branch reconstruction, aimed at treating Stanford type B aortic dissection [1] - The system consists of the AnkuraTM Plus aortic arch main stent system and the CSkirtTM aortic arch branch stent system, which entered the "Special Review Procedure for Innovative Medical Devices" in 2022 [1] - Clinical research involving 120 participants demonstrated a technical success rate of 97.5% during surgery, a branch vessel patency rate of 99.1% after one year, and a low type III endoleak occurrence rate of only 1.8% [1] Group 2: Technological and Market Implications - Windowing technology is recognized as a mainstream technique for reconstructing aortic arch branches in thoracic endovascular aortic repair (TEVAR), with international guidelines recommending its use for patients with insufficient anchoring zones or affected left subclavian arteries [2] - The company holds independent intellectual property rights for the product, which is expected to provide a complete, safe, and effective endovascular treatment solution for aortic dissection involving the aortic arch [2] - The product's market approval enhances the company's product portfolio in the peripheral vascular intervention field, aiming to offer a more flexible, comprehensive, and user-friendly solution for aortic arch endovascular reconstruction [2]