JensCare's LuX-Valve, the World’s First Transcatheter Tricuspid Valve Replacement System, Completes Pivotal Trial Enrollment, Marking a Key Milestone Ahead of IPO

VCBeat (WeChat ID: vcbeat) has learned that on August 18, 2021, with the close collaboration of Academician Hu Shengshou and Professor Pan Xiangbin’s team at Fuwai Hospital, Chinese Academy of Medical Sciences, LuX-Valve implantation procedures were successfully performed on two patients with tricuspid regurgitation. This marks the completion of patient enrollment for the confirmatory clinical trial of LuX-Valve, a globally innovative product independently developed by Jenscare. This achievement represents the most advanced research progress among similar products worldwide and constitutes a significant milestone for Jenscare’s flagship product, further confirming the safety and efficacy of LuX-Valve.

Professor Pan Xiangbin is performing a tricuspid valve LuX-Valve implantation procedure.

It is reported that eight top-tier medical institutions in China participated in this confirmatory clinical trial. In addition to the teams led by Academician Hu Shengshou and Professor Pan Xiangbin mentioned earlier, the participating institutions included: the team of Director Xu Zhiyun and Professor Lu Fanglin at Shanghai Changhai Hospital; the team of Director Meng Xu and Professor Zhang Haibo at Beijing Anzhen Hospital, Capital Medical University; the team of Director Dong Nianguo and Professor Shang Xiaoke at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; the teams of Professor Guo Yingqiang and Professor Chen Mao at West China Hospital, Sichuan University; the team of Professor Yang Jian at the First Affiliated Hospital of Air Force Medical University of the Chinese People's Liberation Army; the team of Professor Guo Huiming at Guangdong Provincial People's Hospital; and the team of Party Secretary Wang Jian'an and Professor Liu Xianbao at the Second Affiliated Hospital, Zhejiang University School of Medicine. From the feasibility clinical trial to the completion of enrollment in the confirmatory clinical trial, the safety and efficacy of LuX-Valve have been further validated, marking that China’s transcatheter tricuspid valve replacement products and therapeutic technologies are now at the forefront globally.

Tricuspid valve disease is one of the most common cardiac conditions. Due to its insidious onset and the initial lack of attention paid to its clinical symptoms, it is often referred to as the "forgotten valve." Clinically, tricuspid regurgitation is more prevalent than tricuspid stenosis, affecting a substantial patient population. Incomplete closure of the tricuspid valve leads to the backflow of blood from the right ventricle into the right atrium during systole. Over the long term, tricuspid regurgitation can result in heart failure, with symptoms including peripheral edema, ascites, and hepatic pathology.

The global population of patients with moderate-to-severe tricuspid regurgitation increased from 46.6 million in 2016 to 50.6 million in 2020, and is projected to reach 60.7 million by 2030. In China, the number of patients with moderate-to-severe tricuspid regurgitation rose from 8.6 million in 2016 to 9.2 million in 2020, and is expected to increase to 10.6 million by 2030. Patients with tricuspid valve disease suffer from poor quality of life and high mortality rates (approximately 36% of patients with severe tricuspid regurgitation die within one year after diagnosis, and approximately 47.8% die within five years). In recent years, the treatment of tricuspid regurgitation has become one of the urgent clinical priorities.

Despite the high prevalence of tricuspid regurgitation, there are currently no approved transcatheter interventional products for its treatment. In clinical research, transcatheter interventions for tricuspid regurgitation include two approaches: valve repair and valve replacement. Compared with transcatheter tricuspid valve repair, transcatheter tricuspid valve replacement has a broader scope of application and can effectively reduce the severity of tricuspid regurgitation. Therefore, Jenscare has prioritized transcatheter tricuspid valve replacement products as its key area of breakthrough.

After eight years of continuous independent research and development, Jenscare’s LuX-Valve transcatheter tricuspid valve replacement system, which possesses fully independent intellectual property rights, has completed preliminary validation of its safety and efficacy. Adopting a “non-radial force-dependent” design concept, the LuX-Valve minimizes organic damage to patients’ cardiac structures and is suitable for treating high-risk patients with severe tricuspid regurgitation who are not candidates for surgical intervention.

The LuX-Valve transcatheter tricuspid valve replacement system comprises three main components: the prosthetic tricuspid valve, the delivery catheter system, and the loading system. The prosthetic tricuspid valve consists of five key parts: a self-expanding nitinol valve stent covered with polyester, an adaptive annular anti-leak ring, an anterior leaflet clip, a tongue-shaped septal anchoring element, and bovine pericardial leaflets. Furthermore, the LuX-Valve is available in six different sizes to accommodate patients with varying anatomical conditions.

LuX-Valve Prosthetic Valve

In September 2020, Jenscare completed the feasibility clinical trial of LuX-Valve. The all-cause mortality rates at hospital discharge and at 30 days were both 0%, preliminarily confirming the safety and efficacy of LuX-Valve. As of press time, LuX-Valve is the only investigational product worldwide to have completed enrollment in its confirmatory clinical trial. It will be eligible for regulatory submission after one year of follow-up and is poised to become the first commercially available product globally for the treatment of tricuspid regurgitation. Based on the current progress of its clinical trials, Jenscare is well-positioned to seize the first-mover advantage in the tricuspid valve replacement device market, becoming a global pioneer in this field.

Meanwhile, adhering to the principle of “independent innovation,” Jenscare continues to develop a comprehensive suite of therapeutic solutions for structural heart disease—including tricuspid valve disease, aortic valve disease, mitral valve disease, and heart failure—thereby further diversifying its product portfolio. As an innovation leader in the field of structural heart disease, Jenscare remains committed to forging ahead and continuously breaking new ground, delivering superior solutions to patients across China and around the world.