Core Viewpoint - The company has received formal notification from the National Medical Products Administration confirming that its Concave Supra integrated arch branch reconstruction system (CSTM stent system) has entered the special review procedure for innovative medical devices, marking a significant advancement in minimally invasive treatment for complex aortic arch aneurysms and penetrating ulcers [1][3]. Group 1: Product Development and Innovation - The CSTM stent system is the world's first integrated arch branch reconstruction solution designed for complex aortic arch pathologies, addressing the challenges of traditional endovascular techniques [1][2]. - The product features a unique groove design that fits the anatomy of the arch, significantly reducing the risk of cerebral ischemia, and employs an integrated structure to prevent endoleaks while ensuring high branch patency rates [2][3]. - The company holds independent intellectual property rights for the product, which has already been successfully implanted in multiple clinical cases across Germany, Switzerland, Greece, and Hong Kong, receiving high recognition from international clinical experts [3]. Group 2: Clinical Research and Results - The feasibility study (FIM study) led by Professor Shu Chang completed enrollment of 10 patients in June 2023, showing no endoleaks and high patency rates at 12-month follow-up, validating the safety and effectiveness of the CSTM stent system [2]. - A subsequent prospective, multi-center clinical trial aims to enroll 103 patients across 25 authoritative centers, with 52 patients enrolled as of August 31, 2025, demonstrating a 100% technical success rate and a 1.92% all-cause mortality rate at 30 days post-operation [2]. - The absence of severe complications such as permanent paralysis or retrograde type A aortic dissection further supports the clinical value and application prospects of the CSTM stent system in aortic arch reconstruction [2]. Group 3: Market Impact and Future Outlook - The entry of the CSTM stent system into the special review procedure is expected to shorten the registration process and accelerate its market launch, benefiting patients with aortic arch aneurysms and ulcers [3]. - The anticipated market introduction will expand the company's product offerings and establish a comprehensive minimally invasive treatment solution for aortic diseases, covering key technical areas such as endovascular reconstruction of the arch branches, visceral branch, and iliac arteries [3].