COMMENCE Aortic Trial
Seven-Year Data

 
 
 
 
 

Seven-year outcomes from the COMMENCE aortic trial were presented at the 103rd annual meeting of the American Association of Thoracic Surgeons (AATS) 2023.1  The COMMENCE trial is an FDA approved pivotal trial designed to evaluate the safety and effectiveness of a bioprosthetic valve with the novel RESILIA tissue.

Excellent outcomes through 7 years

RESILIA tissue data from the COMMENCE aortic trial show:

  • 85.4% freedom from all-cause mortality through 7 years
  • 99.3% freedom from structural valve deterioration through 7 years
  • Clinically stable hemodynamics
    • Effective orifice area was 1.82 ± 0.57 cm2
    • Mean gradient was 9.4 ± 4.5 mmHg

To read about the results, patient demographics, study methods, and key points, download the COMMENCE aortic trial 7-year clinical summary.

Proven performance at 7 years

With excellent outcomes through 7 years, the COMMENCE trial demonstrates encouraging results for bioprostheses with RESILIA tissue.

Discover the Difference with RESILIA Tissue

Proprietary tissue integrity preservation technology mitigates residual aldehydes. This enables dry storage that simplifies handling.

RESILIA* tissue offers enhanced anti-calcification technology that will potentially allow the valve to last longer than conventional bioprosthetic valves.2

 

*No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.

7-year data from the COMMENCE aortic trial represent the longest follow-up after aortic valve replacement with this novel tissue in a large IDE trial.

The COMMENCE trial 7-year data is only part of the clinical story

 

Our trials aim to raise the bar on established valve safety and efficacy by adding new study variables. Our COMMENCE trial increased the patient population from the EU Feasibility trial, and the RESILIENCE trial is designed to look at different outcome measures to help further establish long-term valve durability.

 

See the growing body of RESILIA tissue data by visiting the Inspiring Results page.

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References

  1. Beaver T, Bavaria JE, Griffith B, et al. Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis. Presented at the 103rd Annual Meeting of the American Association for Thoracic Surgery, May 2023.”
  2. RESILIA tissue tested against tissue from commercially-available bovine pericardial valves from Edwards in a juvenile sheep model. Flameng, et al. J Thorac Cardiovasc Surg 2015;149:340-5.

 

 

No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients

 

Medical device for professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).

 

Edwards, Edwards Lifesciences, the stylized E logo, COMMENCE, INSPIRIS, INSPIRIS RESILIA, 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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