有效性结果显示：(1)所有受试患者三尖瓣反流等级得到改善，30天资料显示97.81%的患者显示无或仅微量瓣周漏，6个月期资料显示97.62%的患者显示无中度及以上反流，1年期资料显示95.30%的患者显示无中度及以上反流；(2)于美国纽约心脏协会心功能改善方面，30天资料显示约80%的患者由术前III/IV级提升至I/II级，6个月期资料显示约92%的患者由术前III/IV级提升至I/II级，1年期资料显示约85%的患者由术前III/IV提升至I/II级；及(3)于生活品质改善方面，30天资料显示患者堪萨斯市心肌病变问卷评分平均提升15分，6个月期资料显示患者评分平均提升20分，1年期资料显示患者评分平均提升21分。Gelonghui, October 31 | Jianshi Technology-B (09877.HK) announced that recently, the one-year clinical follow-up results of the LUX-VALVE Plus Transcatheter Tricuspid Valve Interventional System (TRAVEL II) were released at the 2024 American Transcatheter Cardiovascular Academic Conference (TCT 2024).
TravelII is mainly used to evaluate the long-term safety and efficacy of LUX-Valve Plus in patients with severe tricuspid valve reflux. The TRAVEL II clinical trial included a total of 96 patients from 15 centers in China.
The results of this clinical study showed that (1) the success rate of the device was about 97%; and (2) the average operation time of the device was 35.56 ± 20.82 minutes.
Efficacy results showed: (1) The tricuspid valve reflux level of all tested patients improved. The 30-day data showed that 97.81% of patients showed no or only minor perivalvular leakage, the 6-month data showed no moderate or above reflux, and the 1-year data showed that 95.30% of patients showed no moderate or above reflux; (2) In terms of improving cardiac function, the 30-day data showed that about 80% of patients were upgraded from grade III/IV before surgery to grade I/II. The 6-month data showed that about 92% of patients had no moderate or above reflux. Level IV Upgraded to grade I/II. The 1-year data showed that about 85% of patients were upgraded from III/IV before surgery to grade I/II; and (3) in terms of improving quality of life, 30-day data showed an average increase of 15 points in the Kansas City cardiomyopathy questionnaire, 6-month data showed an average increase of 20 points, and 1-year data showed an average increase of 21 points in patient ratings.
The one-year clinical follow-up results of the TRAVEL II study showed that LUX-Valve Plus had excellent clinical performance in the medium to long term. After entering a longer clinical observation period, the incidence of safety events remained low, and the efficacy continued to improve, further improving patients' cardiac function and quality of life, bringing continuous clinical benefits.
As of the date of this announcement, the company's self-developed transcatheter tricuspid valve replacement system products have been implanted in more than 600 cases worldwide, and the longest follow-up record has been over six years. The company will continue to advance the application and commercialization of the company's products worldwide.
