Jenscare Scientific Co., Ltd. (HKG: 9877), a Ningbo-based manufacturer of devices for structural heart disease, has released promising one-year results from a confirmatory study of its transcatheter tricuspid valve replacement system, LuX-Valve.
The prospective, multi-center, single-arm study aimed to evaluate the safety and efficacy of the LuX-Valve in patients suffering from severe tricuspid regurgitation, enrolling a total of 126 participants. The primary endpoint focused on the one-year cumulative all-cause mortality rate post-surgery. The results demonstrated that LuX-Valve significantly reduced tricuspid regurgitation, enhanced heart function, and improved overall quality of life for patients. Notably, ultrasound assessments revealed that 99.1% of patients experienced an improvement in tricuspid regurgitation grade, with 94.4% reducing to mild or below, and 75.7% achieving no or trace regurgitation.
At the 30-day follow-up, 66.3% of patients saw their New York Heart Association (NYHA) functional class improve from preoperative grades III/IV to I/II. This figure increased to 79.8% at the one-year mark, underscoring the sustainable benefits of the LuX-Valve in enhancing heart function. Additionally, the baseline six-minute walking distance (6MWD) improved from 324.3 meters to 333.6 meters at 30 days, further rising to 383.2 meters at one year, indicating a significant enhancement in patients’ quality of life.- Flcube.com
