The ScienCrown structural design is based on clinical practice, effectively solving existing difficulties such as poor valve expansion, inaccurate positioning, displacement risk, and coronary artery obstruction during TAVR surgery, achieving multiple innovative breakthroughs, and possessing multiple patents. As the first domestically developed self-expanding short valve, it combines the dual advantages of a self-expanding valve and a balloon-expandable valve. It is suitable for patients with severe aortic valve calcification stenosis who need aortic valve replacement and are not suitable for conventional surgical valve replacement after evaluation by the heart team. This product, combined with the ScienMelon aortic valve balloon dilatation catheter that has been approved for marketing some time ago, is expected to provide a more comprehensive and reliable integrated solution for clinical use.
As the CRO partner of the project, LINKS's operation team and medical team provided Lepu Medical with a full range of clinical services and medical technical support in the process of preclinical preparation, clinical monitoring, follow-up, and project completion, relying on their professional and efficient work attitude and rich industry experience. It is worth mentioning that the project completed the enrollment work during the epidemic from September 2021 to September 2022. The LINKS team actively coordinated and worked hard to cooperate with the researchers' screening recommendations and enrollment work. At the project completion stage, with the full support of the company, the summary report of the dual-lead units was signed more than two months after the last case was followed up, helping the applicant to complete the registration submission within the plan.