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心泰医疗(02291.HK):ScienCrown经导管植入式主动脉瓣膜系统取得医疗器械登记证

Xintai Medical (02291.HK): ScienCrown transcatheter implanted aortic valve system has obtained the medical instruments registration certificate.

Gelonghui Finance ·  Dec 17 05:25

On December 17, Gloronghui reported that the China National Pharmaceutical Administration has granted the medical device registration certificate for the ScienCrown transcatheter aortic valve system (registered by Lepu (Peking) Medical Instrument Co., Ltd.).

The design of the ScienCrown transcatheter aortic valve system is based on clinical realities, effectively addressing existing challenges such as poor valve expansion during TAVR, inaccurate positioning, risk of displacement, and coronary artery obstruction, achieving multiple innovative breakthroughs and possessing several patents. The product has the following features and advantages: (1) It uses anti-calcification bovine pericardial leaflets, which have higher durability; the short valve frame does not obstruct the coronary openings, allowing for safe and effective coronary re-intervention; (2) The self-expanding straight tube design has strong compliance and stable support, providing a larger valve orifice area, effectively reducing pressure differences and minimizing long-term complications; (3) The fully hanging connection combined with a pre-bent delivery system allows smooth arch passage and coaxial release, enabling stable retrieval and repositioning, making operations convenient and safe; and (4) It offers both transfemoral and transapical dual access approaches for interventional treatments, providing more choices to meet various clinical needs.

In the future, the company will continue to uphold the spirit of innovation, deepen clinical cooperation, continuously optimize product performance, expand application scenarios, and contribute more to the development of the cardiovascular intervention field for the benefit of patients.

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