Edwards Presents Clinical Data on Transcatheter Mitral and Tricuspid Programs

May 18, 2021—Edwards Lifesciences announced that clinical results from the company’s transcatheter mitral and tricuspid programs were presented during the late-breaking clinical trials sessions at the virtual EuroPCR 2021 conference.

According to the company, the presentations included evaluations of the transfemoral Evoque transcatheter tricuspid valve replacement system and the Pascal and Cardioband transcatheter tricuspid and mitral valve repair systems.

The company noted that the Pascal and Cardioband systems have received CE Mark approval for treatment of patients with both mitral and tricuspid valve disease, and both devices are available commercially in Europe. Pascal and Cardioband are not approved in the United States and are only available via clinical trials. The Evoque system is an investigational device and is not available for sale in any country.

Edwards stated that the 30-day outcomes from the TRISCEND study of the Evoque system demonstrated the device’s technical feasibility and an acceptable safety profile, along with improvements in tricuspid regurgitation (TR) and symptoms in patients with clinically significant TR. The 30-day results showed device and procedural success rates of 98% and 94%, respectively. Additionally, there was a significant reduction in TR severity, with 98% of patients experiencing mild or less.

Next, 2-year outcomes from the CLASP study of the Pascal system for mitral valve repair demonstrated a sustained rate of survival of 80%, a clinical events committee-adjudicated rate of freedom from heart failure rehospitalization of 87%, and an 85% reduction in annualized heart failure hospitalization rates.

The company noted that patients enrolled in the CLASP study had symptomatic, clinically significant mitral regurgitation (MR) despite optimal medical therapy. Patients treated with the Pascal system also experienced durable MR reduction, with evidence of left ventricular reverse remodeling. At 2 years, 78% of patients had mild (1+) or none/trace MR and 97% had ≤ 2+ MR, with echo core lab adjudication.

In the CLASP TR early feasibility study (EFS) of the Pascal system for tricuspid valve repair, the 6-month outcomes demonstrated favorable safety and significant TR reduction. The results showed high implant, procedural and clinical success rates, while also demonstrating low complication rates. Patients enrolled in the CLASP TR EFS had symptomatic severe TR, and, at 6 months after treatment, 78% of patients had mild or moderate TR. Patients also experienced positive functional and quality of life outcomes, which were sustained at 6 months.

Finally, the TriBAND postmarket clinical follow-up study of the Cardioband system demonstrated a 30-day device success of 97%, and all-cause mortality of 1.6%. Patients in the study had chronic symptomatic TR, and 94% of patients had severe or greater TR at baseline. Data from 30 days after treatment with the Cardioband system showed that 85% of patients experienced at least one grade reduction of significant TR, as well as improvements in functional status and quality of life measures, reported Edwards Lifesciences.