ScienCrown™ TAVR System Approved in China: World's First Self-Expanding Short Valve with Balloon-Expandable Advantages

In December 2024, Lepu Scientech announced that its ScienCrown™ Transcatheter Aortic Valve Replacement (TAVR) System received approval from China's National Medical Products Administration (NMPA). As the world's first and only self-expanding short-valve TAVR system combining the benefits of balloon-expandable technology, it aims to enhance procedural safety and long-term outcomes for patients with severe aortic stenosis (AS) unsuitable for traditional surgery.

As principais inovações abordam desafios clínicos críticos:

1. Os folhetos pericárdicos bovinos anticalcificação e um design de stent curto garantem durabilidade, minimizam a obstrução coronariana e preservam o acesso coronário futuro.

2. Um stent de tubo reto autoexpansível equilibra flexibilidade e estabilidade, otimizando a área do orifício da válvula e reduzindo os gradientes de pressão.

3. a tecnologia da completo-recaptura 12-hook e a entrega pre-curvada permitem o posicionamento preciso, o retrievability 100% e o desenvolvimento liso.

4. A compatibilidade do Duplo-acesso (transfemoral/transapical) expande opções processuais.

Clinical data from multicenter studies demonstrated 98.4% immediate implantation success rate, 99.2% procedural success rate, and low rates of mortality and pacemaker implantation. Patients showed sustained hemodynamic improvements post-TAVR: stable mean pressure gradients (~10 mmHg), increased effective orifice area (>1.5 cm²), and enhanced left ventricular ejection fraction. No severe paravalvular leaks were reported.

Combined with the approved ScienMelon™ Balloon Catheter, Scientech offers a comprehensive solution for AS treatment, reinforcing China's leadership in innovative structural heart therapies.

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