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.

Las innovaciones clave abordan los desafíos clínicos críticos:

1. los prospectos pericárdiacos bovinos de la Anti-calcificación y un diseño del acorto-stent aseguran durabilidad, minimizan la obstrucción coronaria, y preservan el acceso coronario futuro.

2. un stent de tubo recto autoexpandible equilibra flexibilidad y estabilidad, optimizando el área del orificio de la válvula y reduciendo los gradientes de presión.

3. tecnología de recaptura completa de 12 ganchos y entrega pre-curvada permiten un posicionamiento preciso, 100% de recuperación y despliegue suave.

4. la compatibilidad del Dual-acceso (transfemoral/transapical) amplía opciones procesales.

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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