Shanghai, China - VitaFlow™ Transcatheter Aortic Valve and Delivery System ("VitaFlow™"), in-house developed by Shanghai MicroPort Medical (Group) Co ., Ltd. ("MicroPort®"), was granted the Green-Path by the China Food and Drug Administration ("CFDA"), a special fast-track procedure for innovative medical devices to gain CFDA approval.
The outflow of VitaFlow™ System adopts creativity design with low density cells, which provides better alignment during deployment, the large cells spare more space for coronary access. The extended inner and outer skirt may reduce perivalvular leak and heart block. The delivery system has exclusive hybrid driven handle, which offers more simplified operation and allows easier wire manipulation during deployment. The reinforced inner/outer shaft enhances stability and accuracy of valve deployment.
Currently, the prospective, multi-center, single-armed clinical trial of evaluating the safety and efficacy of VitaFlow™ in the treatment of severe aortic stenosis has been launched in China with relevant researches running smoothly. The Green-Path status will significantly shorten the approval time for VitaFlow™, which means the device will be launched in the market earlier than expected to benefit patients with aortic stenosis that can’t treated with traditional methods.