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.

Inovasi utama mengatasi tantangan klinis yang penting:

1. Selebaran bovin anti-kalisifikasi dan desain stent pendek memastikan daya tahan, meminimalkan obstruksi koroner, dan mengatur akses koroner di masa depan.

2. Tabung lurus yang berkembang sendiri keseimbangan stent dan stabilitas, mengoptimalkan area lubang katup dan mengurangi gradien tekanan.

3. Teknologi recapture penuh 12 kait dan pengiriman pre-curved memungkinkan pemosisian yang tepat, pengambilan 100% yang cepat dan peluncuran yang lancar.

4. Kompatibilitas akses ganda (transfemoral/transical) mengembang opsi resisural.

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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