Promising Results from Jenscare's LuX-Valve Plus and JensClip Trials Presented at EuroPCR 2025

Jenscare's Innovations in Heart Valve Technology Presented at EuroPCR 2025

Jenscare Scientific Co., Ltd., a groundbreaking medical device company, showcased significant results from its latest studies at EuroPCR 2025 in Paris, France. The event highlighted the 30-day follow-up results of the LuX-Valve Plus TRINITY trial and the one-year follow-up outcomes of the JensClip TMVr system. These trials represent important advancements in treating patients with severe heart valve conditions, particularly those with high surgical risks.

LuX-Valve Plus: A Novel Solution for Tricuspid Regurgitation

The TRINITY trial, which is a global, prospective, multicenter, single-arm clinical study, focuses on evaluating the safety and effectiveness of the LuX-Valve Plus in patients suffering from severe tricuspid regurgitation (TR). The study enrolled a total of 161 patients across 20 centers, primarily from France, Germany, Spain, Denmark, and the UK. With an average age of 77, these patients faced a challenging combination of comorbidities that put them at significant surgical risk.

Within this cohort, an impressive 97% device success rate was recorded, with an average device operation time of just 41.6 minutes. The study's safety metrics indicated a 30-day composite event rate of 14.8%, demonstrating the potential of LuX-Valve Plus to perform effectively and safely. Shockingly, only 1.3% of patients experienced cardiovascular mortality post-operation, and there were no reported cases of major access site complications or device-related pulmonary embolisms.

Additionally, improvements in quality of life were considerable, with 95.7% of patients demonstrating no more than moderate TR at the 30-day mark, and 84.1% achieving better functionality reflected by lower NYHA classification. These outcomes have profound implications for the treatment of patients who previously had limited options due to high surgical risks.

JensClip: Committed to Mitigating Mitral Regurgitation

Alongside the success of the LuX-Valve Plus, Jenscare also presented data on its JensClip TMVr system, aimed at addressing symptomatic degenerative mitral regurgitation (DMR). This study engaged 114 patients, with a median age of 71, reflecting a demographic that frequently suffers from associated conditions such as hypertension and coronary artery disease.

Over one year, the JensClip demonstrated a device success rate of 97% within the initial 30 days, establishing itself as a reliable intervention for patients. Notably, all-cause mortality was minimal at 1.8%, and incidences of unplanned surgeries and strokes remained relatively low. Furthermore, by the end of the year, 96.29% of patients no longer experienced above moderate MR, and substantial improvements were noted in functional capacity, with KCCQ scores rising around 20 points.

According to Professor Xiangbin Pan, the JensClip device delivers innovative solutions for those at high surgical risk, enhancing procedural safety while achieving sustained reductions in mitral regurgitation.

Advancements and Future Implications

Both trials underscore Jenscare’s commitment to pushing boundaries in cardiovascular treatment, demonstrating the effectiveness and safety of their innovative devices. The LuX-Valve Plus and JensClip not only promise to alleviate symptoms for high-risk patients but also contribute to enhancing their overall quality of life, which has historically been a challenging obstacle in this demographic.

As ongoing clinical research continues, including further follow-ups for TRINITY and additional studies in the US, Jenscare aims to solidify its position at the forefront of medical device innovation. With unwavering dedication to improving outcomes for patients with structural heart disease, Jenscare’s endeavors could change the landscape of heart valve interventions forever, making these once-daunting procedures more accessible and safer for those in dire need.

With over 700 cases of LuX-Valve series products implanted and maintaining a forward-thinking approach towards real-world applications, Jenscare is certainly a company to watch in the coming years within the field of interventional cardiology.