Five-year data on RESILIA tissue in the mitral position
With many patients desiring to avoid lifelong anticoagulation therapy, preferences in mitral valve replacement are evolving. The biggest obstacle with tissue valves has been durability. RESILIA tissue, designed with anti-calcification technology, is helping to overcome that obstacle.*1
So far, the COMMENCE aortic trial has resulted in seven-year data in support of RESILIA tissue for aortic valve replacement. Now, five-year outcomes in the mitral patient cohort support the use of RESILIA tissue in the mitral valve position as well.
* No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.
The first clinical data of RESILIA tissue in the mitral position*1
A prospective, single-arm trial with adult patients requiring mitral valve replacement (MVR) was conducted at 17 sites in the United States and Canada.2
A total of 82 patients successfully underwent MVR with Edwards Lifesciences Model 11000M (Carpentier-Edwards PERIMOUNT Magna Mitral Ease valve with RESILIA tissue).2 The median follow-up for the study cohort was 5.1 (1.4) years, with a total of 374.2 patient-years in aggregate.2
Excellent outcomes at 5 years
In the study, patients who had MVR with a RESILIA tissue valve showed2:
- 98.7% freedom from SVD through 5 years
- 97.1% freedom from reoperation through 5 years
Additionally, hemodynamic valve function measurements were clinically stable through the 5-year follow-up period.2
Expanding possibilities
Through 5 years of follow up, the COMMENCE mitral trial reported a favorable safety profile and clinically stable hemodynamic performance. The clinical implications of this study support the use of RESILIA tissue in the mitral position with excellent durability out to 5 years.2
These results show clinical evidence in support of RESILIA tissue. The information shared here represents an overview of key trial data. To review more findings from the trial, download the clinical summary below.
RESILIA tissue 5-year outcomes in the mitral position
Download the clinical summary
Promising data. Inspiring results.
Explore the data
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