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.

Les innovations clés répondent à des défis cliniques critiques:

1. les feuillets péricardiques bovins d'Anti-calcification et une conception de court-stent assurent la longévité, réduisent au minimum l'obstruction coronaire, et préservent le futur accès coronaire.

2. un stent à tube droit auto-expansible équilibre la flexibilité et la stabilité, optimisant la zone de l'orifice de la valve et réduisant les gradients de pression.

3. la technologie de plein-recapture de 12 crochets et la livraison pré-incurvée permettent le positionnement précis, le retrievability 100% et le déploiement sans heurt.

4. La compatibilité à double accès (transfémorale/transapicale) élargit les options procédurales.

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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