Sinuous™ Heparin-Coated Covered Stent Makes Debut at the 11th Vascular Innovation Conference

The First Affiliated Hospital of Chongqing Medical UniversityProf. Zhao YuAs the Chair of this conference and the Principal Investigator (PI) for the Sinuous™ clinical trial, [he/she] stated: The launch of Sinuous™ aligns with clinical needs in China and fills a market gap. We look forward to accelerating the product's clinical translation and application, providing more solutions produced in China for vascular interventional diagnosis and treatment, and driving the innovative development of medical devices produced in China.

President of the Vascular Surgery Branch of the Cross-Strait Medical and Health Exchange Association, Zhongshan Hospital, Fudan UniversityHospitalProfessor Fu WeiguoIt is noted that: Chinese-made medical devices are accelerating their transition from a "catch-up" phase to international competition. Sinuous™ has achieved a breakthrough in benchmarking against imported products in the heparin-coated covered stent sector, demonstrating the innovation potential of Chinese-made devices in niche segments.

General Manager of Hongpu MedicalMr. Li HuIntroduction: Sinuous™ has undergone eight years of research and development, continuously advancing key technologies such as covering technology, delivery systems, and heparin coatings. In the future, Hongpu Medical will deepen its collaboration with BrosMed Medical to accelerate the product’s commercialization and better serve clinical needs.

Chairman of BrosMed MedicalMr. Li BinStated: BrosMed Medical will leverage its accumulated expertise in R&D, commercialization, and global distribution networks to partner with Hongpu Medical in advancing the clinical application of Sinuous™ in China and expanding into international markets, thereby providing patients worldwide with original Chinese interventional device solutions.

Witnessed by all distinguished guests in attendance,Sinuous™ Heparin-Coated Covered Stent Launch Ceremonywas held grandly.

Academic Sharing Session, BrosMed MedicalChen YongPresents a featured presentation on "Design Analysis of the Sinuous™ Heparin-Coated Covered Stent," highlighting the product's design features and clinical application value.

The report indicates that the Sinuous™ stent featuresComprehensive Specification and Model Portfolio, can meet various peripheral vascular reconstruction needs; it is equipped withEHBS™ Heparin Terminal Covalent Bonding Technology, helps maintain the anticoagulant activity on the graft surface, supporting long-term vascular patency postoperatively. Meanwhile, the product throughStructural OptimizationEnhances support, flexibility, and durability, adapting to complex vascular anatomies.

As a domestically produced heparin-coated covered stent solution, Sinuous™ addresses clinical needs by providing a new domestic option for peripheral vascular interventional therapy.

Prof. Fenghe LiDeliver a thematic presentation on 《Interpretation of Sinuous™ Clinical Trial Data》, analyzing the clinical study results of Sinuous™ in light of clinical challenges such as the high recurrence rate of hemodialysis access stenosis and suboptimal long-term patency.

Based on data from a multicenter, prospective, single-arm objective performance criteria (OPC) study in China (N=141), the study shows that,The Sinuous™ device success rate, procedural success rate, and clinical success rate were all 100%; the 6-month and 12-month target lesion primary patency rates were 79.43% and 58.16%, respectively,The safety and efficacy of the product in the treatment of hemodialysis access stenosis were verified.

Professor Li Fenghe stated that Sinuous™, as a heparin-coated peripheral vascular covered stent produced in China with independent intellectual property rights, demonstrates favorable handling characteristics and long-term patency outcomes in clinical data, and is expected to provide a reliable Chinese-produced option for interventional therapy of hemodialysis access.

During the invited expert discussion session,Prof. Guo Mingjin, Prof. Gao Zhanfeng, Prof. Li Kunsparked a lively discussion among the attending experts. The experts respectively noted that Sinuous™ arrives at a pivotal industry juncture where the clinical application of imported products is constrained by centralized procurement policies, precisely filling a gap in the clinical market. They look forward to the product’s swift regulatory approval and market launch, enabling its integration into routine clinical practice to effectively address real-world challenges in hemodialysis vascular access and peripheral vascular intervention, thereby benefiting a broad patient population. Furthermore, they recommended expanding the product’s indications to better accommodate multi-scenario clinical diagnosis and treatment needs, and continuously iterating the design by developing thinner and finer delivery sheaths. These enhancements would improve crossability in complex procedures, optimize hands-on clinical handling, and drive further product evolution.