Jenscare’s Lux-Valve Plus Evaluated in 1-Year TRAVEL II Study Data

November 8, 2024—Jenscare Scientific Co., Ltd., which is based in Ningbo, China, recently announced the 1-year outcomes from the TRAVEL II trial of Lux-Valve Plus, the company’s transcatheter tricuspid valve replacement (TTVR) system. The device is designed to treat patients with severe tricuspid regurgitation (TR) and high surgical risk.

The company stated that the TRAVEL II results showed that the Lux-Valve Plus TTVR system is safe and effective in achieving short delivery times, low composite event rates, significant TR reduction, and improvements in functional and quality of life (QOL) metrics at 1 year.

The findings were presented during the late-breaking clinical trial sessions at TCT 2024, the 36th annual Transcatheter Cardiovascular Therapeutics annual scientific symposium of the Cardiovascular Research Foundation held October 27-30 in Washington, DC.

According to the company, TRAVEL II aims to evaluate Lux-Valve Plus’s long-term safety and efficacy in the application on patients with severe TR and high surgical risk. The clinical trial enrolled 96 patients from 15 centers in China. The patients’ average age was 71.35 years and the average Society of Thoracic Surgeons (STS) score of 9.09%.

Additionally, 37.5% of the patients had previous left heart valve surgery or intervention, and 15.63% of patients had previously been implanted with a pacemaker/implantable cardioverter defibrillator. Patients were combined with multiple other comorbidities, which formed a poor baseline and increased the risks of surgical treatment or difficulties of other interventional therapies.

Jenscare summarized the study results as follows:

• The procedural results included:
  • Device success rate was approximately 97%
  • Average device operation time was approximately 35.56 minutes
• The safety indicators included:
  • The incidence of composite events remained low at 12.5%
  • Incidence of myocardial infarction, acute liver failure, cardiovascular injury requiring surgical intervention, life-threatening hemorrhage were 0%
  • All-cause mortality was only 4.17%
  • Incidence of acute renal failure, severe paravalvular leakage, and conversion to surgical tricuspid valve replacement or tricuspid valvuloplasty were 1.04%, 2.08%, and 3.13%, respectively
  • Incidence of new onset degree III atrioventricular block requiring permanent pacemaker implantation was only 2.08%
• The efficacy indicators included:
  • Significant improvements in TR grade, New York Heart Association (NYHA) classification, and QOL
  • At 1 year, 95.30% of patients showed no moderate or greater TR
  • 85% of patients showed cardiac function improvement from preprocedure NYHA class III/IV to class I/II
• QOL indicators included:
  • Patients increased their Kansas City Cardiomyopathy Questionnaire averaging score by 21 points
  • Cardiac function and QOL of patients improved continuously

In the Jenscare press release, Professor Juan F. Granada, MD, concluded that the Lux-Valve Plus system is a versatile TTVR device that does not depend on radial force for anchoring. Further, its design—ventricular septal anchor and leaflet-grasping clips—provides optional mechanisms for anchoring and stability. The multicenter, TRAVEL II study showed that Lux-Valve Plus system is safe and effective in achieving short delivery times, low 1-year composite event rates, significant TR reduction, and improvement in functional and QOL metrics at 1 year.

Additional studies in Europe and the United States using the Lux-Valve Plus system are underway, and more clinical results are expected to be released in the future, advised Jenscare.