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.

Anahtar yenilikler kritik klinik zorlukları ele alır:

1. anti-kalsifikasyon sığır perikardiyal broşürler ve kısa stent tasarımı dayanıklılığı sağlar, koroner tıkanıklığı en aza indirir ve gelecekteki koroner erişimi korur.

2. kendiliğinden genişleyen düz tüp stent, esneklik ve stabiliteyi dengeler, valf deliği alanını optimize eder ve basınç gradyanlarını azaltır.

3. 12-hook tam yeniden yakalama teknolojisi ve önceden kavisli teslimat, hassas konumlandırma, % 100 geri alınabilirlik ve pürüzsüz dağıtım sağlar.

4. çift erişim uyumluluğu (transfemoral/transapikal) prosedür seçeneklerini genişletir.

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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