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.
Key innovations address critical clinical challenges:
1. Anti-calcification bovine pericardial leaflets and a short-stent design ensure durability, minimize coronary obstruction, and preserve future coronary access.
2. A self-expanding straight-tube stent balances flexibility and stability, optimizing valve orifice area and reducing pressure gradients.
3. 12-hook full-recapture technology and pre-curved delivery enable precise positioning, 100% retrievability and smooth deployment.
4. Dual-access compatibility (transfemoral/transapical) expands procedural options.
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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