Chengdu, China – On November 25, MicroPort Shanghai CardioFlow Medtech Co., Ltd. ("MicroPort® CardioFlow") attended the 2017 PCR-CIT China Chengdu Valves and displayed its VitaFlow™ Transcatheter Aortic Valve and Delivery System ("VitaFlow™"). The conference was hosted by PCR, CIT, and Huaxi Hospital of Sichuan University.
In the session of transcatheter aortic valve innovative treatment, the representative of MicroPort® CardioFlow delivered a speech about "Innovative Solution of MicroPort®: to Solve the Unmet needs," sharing MicroPort® CardioFlow's understanding in the unmet needs and proposed solutions. According to the speech, there are three keys factors in technical improvement of TAVI treatment: reducing the occurrence rate of postoperative complications, solving the clinical challenges in special anatomic conditions, and ensuring the long-term efficacy. With its innovative skirt design, VitaFlow™ can effectively reduce the paravalvular leak. It keeps its outer diameter at 16F\18F while reinforcing its radial force, which can skillfully expand calcified leaflets. The excellent clinical outcome of VitaFlow™ has won recognition from industry peers. Moreover, the device has achieved breakthrough in coping with bicuspid aortic valve challenge - there has no significant difference of clinical results between 41 bicuspid aortic valve patients (41/110) and other non-bicuspid patients who are enrolled in Chinese FDA clinical trial. Afterwards, MicroPort® CardioFlow introduced the upcoming second-generation of VitaFlow™. Its added recapturable function will greatly lower the difficulty of positioning during the procedure, which effectively improve the success rate and facilitate physicians in operation. The second generation of VitaFlow™ product has many features including direct access, omnidirectional navigation, and reinforced compatibility which would help reduce vascular complication remarkably. In the end, the representative of MicroPort® CardioFlow presented on the development trend of future products. MicroPort® CardioFlow will continue to innovate and increase product offerings based on the unmet clinical needs to provide comprehensive solutions for physicians.
In the session of valve on the second day, Professor Darren Mylott, a renowned cardiologist from Ireland-based Galway University Hospital, made a presentation on the design features and typical cases of MicroPort® VitaFlow™. Professor Darren Mylott shared his clinical experience in VitaFlow™ and introduced its advantages, clinical follow-up, as well as its second-generation recapturable device. In the following debate session of "Should we simplify TAVI procedure in China now?" Professor Darren Mylott once again mentioned the advantages of the second-generation VitaFlow™ in simplifying operation procedures. At the same time, Professor Yundai Chen of Chinese PLA General Hospital and Professor Xiangqing Kong of Nanjing First Hospital of Nanjing Medical University both spoke highly of the excellent clinical performance of VitaFlow™ in patients with heavy calcified leaflets and bicuspid aortic valve, and they said they looked forward to the durability test of the device.
During the conference, many renowned experts visited MicroPort® CardioFlow booth to learn about the design rationale of VitaFlow™ and they highly recognized its innovative design and excellent clinical performance. Up to date, VitaFlow™ has completed one-year clinical follow-up in China. In August 2016, VitaFlow™ 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, which will significantly shorten the approval time for VitaFlow™. VitaFlow™ is expected to gain CFDA approval in 2018.