Leaflex™ catheter performs mechanical scoring of valve calcification, restoring leaflets' mobility and improving valve hemodynamics.

The product was developed by Pi-Cardia Ltd. (Pi-Cardia), a global leader in the development of non-implant catheter-based solutions for treating heart valve calcification, and was introduced to China by Venus Medtech in September 2020. In October 2021, Leaflex™ completed its FIM (First-in-man) clinical trial in China.

The Leaflex™ catheter is designed to be a cost-effective, durable standalone treatment. It can be used for patients who are not planning to undergo transcatheter aortic valve replacement (TAVR) and it can be a means to defer TAVR in patients who may be too young for the procedure. It can also be a preparatory step for improving the outcome of TAVR in heavily-calcified and bicuspid aortic valves. Leaflex is also applicable for patients for those who’ve implanted a prosthetic heart valve for years. Affordable solution with short hospitalization is of great significance for patients suffering from aortic stenosis