Venus Medtech releases seven-year follow-up data on VenusA series, total number of implantations exceeding 10,000
On June 17, Venus Medtech (Hangzhou) Inc. (2500.HK, hereinafter referred to as "Venus Medtech") released the seven-year follow-up data on VenusA series at the 20th China Interventional Therapeutics (CIT 2022). Presented by Prof. Yongjian Wu at Fuwai Hospital, Chinese Academy of Medical Sciences, the data corroborated the long-term efficacy and safety of Venus Medtech’s in-house developed transcatheter aortic valve replacement (TAVR) products, which are the first of its kind approved by NMPA in China.
Data show that there were only 12 cardiac mortality cases at seven postoperative years, accounting for only 13.5% of VenusA-ValveTM implantations, while the incidence of stroke events, the primary safety endpoint of the study, was only 6.7% over seven years. According to Prof. Wu, peak velocity of aortic flow, mean gradient, and left ventricular ejection fraction showed significant improvements in the immediate postoperative period as measured in echocardiography and maintained functional and stable as reflected in long-term outcomes. In addition, the effective aortic valve area was above 1.2cm² on average, sufficiently substantiating the long-term safety and efficacy of VenusA-ValveTM as well as the continuous benefits it brings to patients.
Spanning from September 2012 to February 2015, the study enrolled 101 patients with severe aortic stenosis at multiple hospitals nationwide at an average age of 75.86±6.45 years. Bicuspid aortic valve (BAV) screening found a nearly 50% incidence and prevalent high calcium scores. All patients were diagnosed with severe aortic stenosis and associated clinical symptoms and were treated with TAVR with VenusA-ValveTM.
Strong radial force is a key feature of VenusA-ValveTM. As noted by Prof. Wu, the unparalleled radial force of VenusA-ValveTM protects the valve frame from distortion in a highly calcified environment and ensures the movement space of the leaflets. A recent study titled Multi-center Experience of Transcatheter Aortic Valve Replacement with Venus-A Valves in Real-world Bicuspid Aortic Valve Patients with Severe Aortic Stenosis published in the Chinese Circulation Journal also testified to the safety and efficacy of TAVR with VenusA-ValveTM in BAV patients.
To date, VenusA-ValveTM has been applied in more than 10,000 cases, making Venus Medtech the first maker to hit the five-digit milestone. In 2021, VenusA series maintained its leading position in the industry with a nearly 70% share in the terminal market. In addition, VenusA-ValveTM has been marketed in Colombia, Brazil, Thailand, and other countries outside China.
Eric Zi, Executive Director and General Manager of Venus Medtech commented “Ten years have passed since the first TAVR procedure with Chinese-made VenusA-ValveTM in 2012 in Fuwai Hospital, Chinese Academy of Medical Sciences. The past decade witnessed the meteoric growth and continuous innovation of Venus Medtech’s VenusA series. Although TAVR has been formally introduced to the Chinese market, there are quite a few technical difficulties to be resolved. As a witness and promoter of TAVR’s progress in China, Venus Medtech is ready to make relentless efforts to take it to new heights.”