Edwards updates on heart valve disease clinical programs

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Edwards Lifesciences has announced clinical results from the company’s transcatheter mitral and tricuspid programs have been presented and confirm positive outcomes for patients impacted by mitral or tricuspid heart valve disease.

The company said the two-year outcomes from the CLASP study of the PASCAL system for mitral valve repair demonstrated a sustained high rate of survival at 80 per cent as well as 87 per cent clinical events committee (CEC) adjudicated freedom from heart failure rehospitalisation and an 85 per cent reduction in annualised heart failure hospitalisation rates.

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 remodelling. At two years, 78 per cent of patients had mild (1+) or no trace MR and 97 per cent had ≤2+ MR, with echo core lab adjudication.

The company said six-month outcomes from the CLASP TR early feasibility study of the PASCAL system for tricuspid valve repair demonstrated favourable safety and significant TR reduction.

"The results showed high implant, procedural and clinical success rates, while also demonstrating low complication rates," it said.

Patients enrolled in the CLASP TR study had symptomatic severe TR and, at six months after treatment, 78 per cent of patients had mild or moderate TR. 

Results at 30 days from the TriBAND post-market clinical follow-up study of the cardioband tricuspid valve reconstruction system demonstrated high device success of 97 per cent and low all-cause mortality of 1.6 per cent. Patients in the study had chronic symptomatic TR and 94 per cents had severe or greater TR at baseline. The company said data from 30 days after treatment with the cardioband system showed that 85 per cent of patients experienced at least one grade reduction of significant TR as well as improvements in functional status and quality of life measures.

“In addition to the positive clinical outcomes the patients treated in these studies experienced, it was also encouraging to see improvements in functional status and quality of life,” said Bernard Zovighian, corporate vice president, transcatheter mitral and tricuspid therapies.

“The patient populations impacted by mitral and tricuspid valve disease are large, diverse and complex. As we pursue our focus to lead and transform their treatment, the results from clinical studies that span our differentiated portfolio of therapies are important contributors to building the evidence to support these transformative transcatheter mitral and tricuspid treatments in different types of patients.”