China's First-in-Class Transcatheter Tricuspid Valve Replacement System LuX-Valve® Enrolls First Patients in Global Pivotal Trial Led by Academician Hu Shengshou’s Team
On June 16, 2020, the team led by Professor Pan Xiangbin from the Structural Heart Disease Center of Fuwai Hospital, under the guidance of Academician Hu Shengshou, Director of Fuwai Hospital, Chinese Academy of Medical Sciences, and Director of the National Center for Cardiovascular Diseases, successfully completed the LuX-Valve procedure.®The first patient was enrolled in the global inaugural registered clinical trial for transcatheter tricuspid valve replacement, marking China’s entry into the international forefront of interventional tricuspid valve therapy.
Today, the first two enrolled patients, aged 71 and 61, both presented with severe tricuspid regurgitation accompanied by leaflet destruction and extreme annular dilation. Both had a history of prior cardiac surgery, combined with biventricular dysfunction, cachexia, and other high-risk surgical factors. Their STS scores were both greater than 8, indicating that they had virtually lost the opportunity for conventional redo surgery and were not candidates for transcatheter minimally invasive valve repair. The two patients could only rely on long-term diuretic therapy to manage edema, but the efficacy of medical treatment was increasingly diminishing. Just as these two elderly patients found themselves in a “desperate” predicament, LuX-Valve®The news that the clinical trial had officially begun brought them hope.
To this end, under the leadership of Academician Hu Shengshou, Professor Pan Xiangbin’s team conducted a thorough evaluation and, upon meeting the study’s inclusion and exclusion criteria, decided to adopt the LuX-Valve.®Minimally invasive transcatheter tricuspid valve therapy was administered to the patients, with a detailed diagnosis and treatment plan formulated. Ultimately, with the concerted efforts and assistance of a multidisciplinary team, two patients successfully underwent transcatheter tricuspid valve replacement (TTVR). The procedure involved only a small incision in the right chest; under beating-heart conditions, access was gained via right atrial puncture, allowing catheter-based intracardiac valve replacement. The valve deployment process took less than 10 minutes. Postoperative imaging confirmed optimal valve positioning and function, with immediate resolution of severe tricuspid regurgitation, thereby marking the launch of LuX-Valve®The Prelude to Multicenter Clinical Trials.
Postoperatively, Professor Pan Xiangbin on China’s Original Lux-Value®The system gave it high praise: “This product features an ingenious design and user-friendly operation, with low requirements for tricuspid valve positioning. Its internationally pioneering new concept of ‘non-radial force dependence’ and the novel technology of ‘intraventricular anchoring’ facilitate intraoperative adjustments, reflecting the LuX-Valve”®Unique Design Appeal. Fuwai Hospital has consistently provided strong support for the development of innovative Chinese medical devices, as exemplified by the LuX-Valve®As the lead institution for the multicenter clinical trial, we will fully support Chinese original technologies in going global, while accelerating clinical progress with guaranteed quality and quantity.”
Tricuspid regurgitation is a common valvular heart disease. In China, there are nearly 10 million patients with moderate-to-severe or severe tricuspid regurgitation. The five-year survival rate for patients with severe tricuspid regurgitation is less than 50%, which is even lower than the survival rates for certain malignant tumors. Patients with severe disease generally have poor cardiac function and multiple comorbidities, making them extremely high-risk candidates for conventional open-heart surgery requiring cardiopulmonary bypass. The in-hospital mortality rate for such surgical interventions exceeds 10%, resulting in a very low treatment rate for tricuspid regurgitation and significantly compromising the health of these patients. LuX-Valve® It is the first domestically developed transcatheter intervention artificial valve replacement device with full independent intellectual property rights, jointly researched and developed by the team of Xu Zhiyun and Lu Fanglin from the Department of Cardiovascular Surgery at Changhai Hospital and Ningbo Jian Shi Company. With its unique design and superior performance, it has successfully been exported to North America and completed human implantation at St. Paul's Hospital in Vancouver, Canada.
The success of these two surgeries officially marked the launch of LuX-Valve®The curtain has been raised on the pivotal clinical trial for the transcatheter tricuspid valve replacement system. This clinical trial is led by Academician Hu Shengshou of Beijing Fuwai Hospital, in collaboration with multiple renowned cardiac centers across China, including Shanghai Changhai Hospital, Beijing Anzhen Hospital, Chengdu West China Hospital, Xi’an Xijing Hospital, Wuhan Union Hospital, and Guangdong Provincial People’s Hospital. Upon completion of all clinical trial activities, LuX-Valve®Poised to become the world’s first approved transcatheter tricuspid valve replacement product, it will bring new hope to a broad population of patients with severe tricuspid regurgitation.