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.

Le innovazioni chiave affrontano le sfide cliniche critiche:

1. I foglietti pericardici bovini anti-calcificazione e un design a breve stent garantiscono la durata, riducono al minimo l'ostruzione coronarica e preservano l'accesso coronarico futuro.

2. Uno stent a tubo dritto autoespandibile bilancia flessibilità e stabilità, ottimizzando l'area dell'orifizio della valvola e riducendo i gradienti di pressione.

3. La tecnologia a ricattura completa a 12 ganci e la consegna pre-curvata consentono un posizionamento preciso, recuperabilità al 100% e una distribuzione regolare.

4. La compatibilità a doppio accesso (transfemorale/transapicale) espande le opzioni procedurali.

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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