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The Surge

Clinical, training, product and patient outcome resources for cardiac surgeons and their heart team partners

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Medical Professional touching digital screen with a heart
Medical Professional touching digital screen with a heart
September 29, 2023

Five-year data on RESILIA tissue in the mitral position

Inspiring Results
Inspiring Results
Inspiring Results

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.

Mitral valve
Mitral valve
Mitral valve

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).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

5 Year Icon
5 Year Icon
5 Year Icon

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

Chart arrow icon going up
Chart arrow icon going up
Chart arrow icon going up

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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References

  1. Flameng W, Hermans H, Verbeken E, et al. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovac Surg. 2015 Jan;149(1):340-5.
  2. Heimansohn DA, Baker C, Rodriguez E, et al. Mid-term outcomes of the COMMENCE trial investigating mitral valve replacement using a bioprosthesis with a novel tissue. Ann Thorac Surg. 2023;115(6):1429-1436.

Important Safety Information

Surgical Mitral Bioprostheses/MITRIS RESILIA Mitral Valve

Indications: For use in patients whose mitral valvular disease warrants replacement of their natural or previously placed prosthetic valve. 

Contraindications: Do not use if surgeon believes such would be contrary to the patient’s best interests. There are no known contraindications with the use of the MITRIS RESILIA mitral valve.

Complications and Side Effects: Stenosis, regurgitation, endocarditis, hemolysis, thromboembolism, valve thrombosis, nonstructural dysfunction, structural valve deterioration, anemia, arrhythmia, hemorrhage, transient ischemic attack/ stroke, congestive heart failure, myocardial infarction, angina, ventricular perforation by stent posts, any of which could lead to reoperation, explantation, permanent disability and death.

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician. See instructions for use for full prescribing information.

Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, COMMENCE, Magna, Magna Mitral Ease, MITRIS, MITRIS RESILIA, PERI, PERIMOUNT, PERIMOUNT Magna, and RESILIA are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

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