VitaFlow®’s 7-Year Follow-Up Data Presents at PCR London Valves

London, UK, 14 December 2023 — Recently, evidence-based data from the VitaFlow® Transcatheter Aortic Valve (VitaFlow®), developed by MicroPort® CardioFlow, were revealed on PCR London Valves, a leading global event on structural heart diseases. These findings highlight VitaFlow®’s exceptional long-term clinical performance.

During the conference, Professor Xiaochun Zhang, a member of Professor Xinda Zhou’s team and the Principal Investigator of the VITAL trial at Zhongshan Hospital, presented the long-term results of implanting VitaFlow® in high-risk surgical patients with severe aortic stenosis. The data demonstrated a significant reduction in all-cause mortality, cardiac mortality, and permanent pacemaker implantation rates over seven years compared to other similar studies. Professor Xiaochun Zhang emphasized that the all-cause mortality rate at seven years was 31.4%, with low occurrences of structural valve deterioration (SVD) and bioprosthetic valve failure (BVF). The effective orifice area of the valve remained at 1.88 cm², and hemodynamic outcomes were similar for both bicuspid and tricuspid aortic valve patients. This provided robust long-term data supporting the safety and efficacy of VitaFlow®.

The VITAL trial is an observational, multicenter, single-arm study aimed at assessing the safety and efficacy of VitaFlow® in patients with severe symptomatic aortic stenosis who are not suitable for Standalone Aortic Valve Replacement (SAVR). The study enrolled 110 patients and pursued medium to long-term data post-implantation through echocardiographic follow-up. The primary endpoint was all-cause mortality at 12 months, with secondary endpoints including device success rate, procedure success rate, major stroke events, valve performance, cardiac function improvement, MACCE events, and quality of life enhancements.

"The seven-year follow-up data from the VITAL trial are impressive", said Professor Ole De Backer from the Heart Center, Rigshospitalet, Denmark. In contrast to the NOTION study, PARTNER 3 trial, or the Evolut low risk trial, 42% of the VITAL trial’s population had a bicuspid aortic valve. "Although this is a remarkably high percentage, the data ultimately demonstrated ideal surgical safety, with an all-cause mortality rate of 31.4% at seven years. While the rate of pacemaker implantation is relatively high, this is closely related to the early trial phase and the large number of bicuspid aortic valve patients. With the ongoing maturation of TAVI technology, it is anticipated that this percentage will decrease to around 10% in the future.”

Professor Darren Mylotte from Galway University Hospitals, Ireland, also commented on the data. He noted that the design of VitaFlow® is based on the severe aortic valve calcification and bicuspid aortic valve anatomy common in patients. The higher pacemaker implantation rate might be a considered choice in the face of such special anatomical structures. "What's noteworthy is that the echocardiographic results at the seven-year follow-up showed a high effective orifice area (EOA) and low transvalvular pressure gradient, which are encouraging and raise expectations for this product."

Professor Oscar Mendiz from Favaloro Foundation University Hospital remarked that, "Over the past two years, our team has repeatedly used VitaFlow® and VitaFlow Liberty® for TAVR procedures. The stability of the valve during deployment impressed us. Even in complex anatomical TAVR procedures, the valve's anchoring position remained consistent before and after deployment, and there were no severe incidents of valve displacement or slippage into the left ventricular outflow tract (LVOT). Additionally, the valve could be slightly adjusted for better coaxiality when released to 60% - 70%."

Professor Angela Mclnerney from Galway University Hospitals, Ireland, highlighted that, “The mixed-density stent design of VitaFlow Liberty® provides better radial support. Its double-layer PET skirt design also effectively reduces the incidence of postoperative paravalvular leak. During the 12-month follow-up, patients treated with VitaFlow Liberty® showed very low transvalvular pressure gradients. Moreover, due to its exceptional flexibility, the valve maintained good coaxiality and stability during deployment."

At the conference, CardioFlow also showcased a booth displaying VitaFlow Liberty® and VitaFlow® Ⅲ Retrievable Steering Delivery System. They announced the imminent launch of clinical studies targeting European patient groups and the expectation of obtaining CE certification for VitaFlow Liberty® in the near future. The clinical data gathered post-approval will provide significant evidence-based support for the subsequent expansion of the valve system's indications.

About MicroPort® CardioFlow

Founded in Shanghai in 2015, MicroPort CardioFlow Medtech Corporation (“MicroPort® CardioFlow”, stock code: 02160.HK) is a leading medical device company in China focusing on research, development and commercialization of innovative transcatheter and surgical solutions for valvular heart disease. The Company’s self-developed second-generation Transcatheter Aortic Valve Implantation (TAVI) product VitaFlow Liberty® is the world’s only commercialized motorized retrievable system. In addition to the TAVI products, the Company has also established a strategic R&D pipeline covering Transcatheter Mitral Valve (TMV) therapies, Transcatheter Tricuspid Valve (TTV) therapies and surgical accessories via independent development and collaboration with global partners. At MicroPort® CardioFlow, we strive to provide total solutions for structural heart diseases, dedicated to providing high quality therapeutic solutions to patients and physicians across the globe.

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