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.

주요 혁신은 중요한 임상 문제를 해결합니다.

1. 석회화 소 심낭 전단지와 짧은 스텐트 디자인은 내구성을 보장하고 관상 동맥 폐색을 최소화하며 미래의 관상 동맥 접근을 보존합니다.

2. 자체 확장 직선 튜브 스텐트는 유연성과 안정성의 균형을 유지하여 밸브 오리피스 영역을 최적화하고 압력 구배를 줄입니다.

3. 12 후크 풀 탈환 기술 및 사전 곡선 배송은 정확한 위치, 100% 검색 및 원활한 배치를 가능하게합니다.

4. 이중 액세스 호환성 (대퇴부 간/transapical) 은 절차 옵션을 확장합니다.

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.

Contact us>>Marketing@lepu-medical.com

Visit lepumedical website for more >>En.lepumedical.com