Suzhou, China – From March 22 to March 25, MicroPort Shanghai CardioFlow Medtech Co., Ltd. ("MicroPort® CardioFlow"), a wholly owned subsidiary of Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®"), attended CIT 2018 and released the one-year clinical outcome of VitaFlow® Transcatheter Aortic Valve and Delivery System ("VitaFlow®").
Transcatheter aortic valve replacement ("TAVR") is an innovative solution for aortic valve stenosis emerging in the 21 century. In the past 15 years, TAVR experienced fast development which has revolutionized the cardiovascular industry. The CIT 2018 gathered several domestic and overseas experts to have in-depth discussion on the current situation and future development of the TAVR technology. On March 24, in "PCR at CIT – Part One: TAVI Treating Aortic Stenosis With Complex Anatomy", Academician Junbo Ge of Zhongshan Hospital of Fudan University for the first time released the one-year follow-up result of VitaFlow® which demonstrated that VitaFlow® is safe and effective in treating severe calcified aortic stenosis.
The clinical study of VitaFlow® is a prospective, multi-center, single-arm trial, enrolling 110 aged patients suffering from severe calcified aortic stenosis who are either high-risk or can’t undergo open surgery, of which 42 have bicuspid aortic stenosis. Patients are followed up for 30 days, six months, one year, and two to five years after TAVR treatment. The One-year follow-up result shows, the occurrence of all-cause mortality is as low as 2.7%, and there is no major stroke. All of the patients reported good hemodynamic function, no moderate or severe PVL, and significant improvement in NYHA class (97% NYHA≤Ⅱ). The treatment outcomes of patients with BAV stenosis are similar with those who with tricuspid valve stenosis. The one-year clinical data of VitaFlow® is competitive compared to similar products.
VitaFlow® is consisted of transcatheter aortic valve, delivery system, balloon catheter and introducer set. Academician Junbo Ge introduced the design rationale of VitaFlow® series products and highly recognized their safe and effective clinical outcome as well as easy operation. VitaFlow® adopts innovative design with inner and outer skirts, which effectively reduce the occurrence of paravalvular leak. In addition, the low density cells design provides better alignment during deployment and large cell design leaves space for interventional treatment of coronary artery. Delivery system with motorized handle enables the physician to deploy the valve while controlling the guide wire, which improves the overall efficiency.
China has a higher percentage of BAV stenosis patients compared with Western countries, and so it has been the focus of the industry to figure out the safe and effective treatment of BAV stenosis. Academician Ge also introduced the subset analysis outcome of the clinical trial in his presentation, and concluded that there is no major difference in the clinical outcome of using VitaFlow® to treat patients with BAV stenosis and those who with tricuspid valve stenosis. After his presentation, experts in attendance had hot discussion on this clinical outcome and spoke highly of the excellent performance of VitaFlow® in treating BAV stenosis. Currently, 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, and is expected to gain CFDA approval in 2018, to benefit domestic patients.