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 pivotal trial designed to evaluate the safety and effectiveness of a bioprosthetic valve with the novel RESILIA tissue.

Download clinical summary

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.

Download 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 valves².

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 build upon one another by adding new variables which further challenge valve safety and efficacy. 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.

References

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.
Flameng W, et al. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovac Surg. 2015; 149:340-5.

Important safety information

RESILIA Tissue Devices

Indications: INSPIRIS RESILIA Aortic Valve - For use in replacement of native or prosthetic aortic heart valves. KONECT RESILIA Aortic Valved Conduit - For use in replacement of native or prosthetic aortic heart valves and the associated repair or replacement of a damaged or diseased ascending aorta. MITRIS RESILIA Mitral Valve - For use in replacement of native or prosthetic mitral heart valves.

Contraindications: There are no known contraindications with the use of these RESILIA tissue heart valve devices.

Complications and Side Effects: INSPIRIS RESILIA Aortic Valve - Thromboembolism, valve thrombosis, hemorrhage, hemolysis, regurgitation, endocarditis, structural valve deterioration, nonstructural dysfunction, stenosis, arrhythmia, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, any of which could lead to reoperation, explantation, permanent disability, and death. Additional adverse events potentially associated with the use of polyester vascular grafts in the KONECT RESILIA AVC include hemorrhage, thrombosis, graft infection, embolism, aneurysm, pseudoaneurysm, seroma, occlusion (anastomotic intimal hyperplasia), immunological reaction to collagen (shown to be a weak immunogen; infrequent, mild, localized and self-limiting), intimal peel formation, and conduit dilatation. MITRIS RESILIA Mitral Valve - Thromboembolism, valve thrombosis, hemorrhage, hemolysis, regurgitation, endocarditis, structural valve deterioration, nonstructural dysfunction, stenosis, arrhythmia, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, ventricular perforation by stent posts, any of which could lead to reoperation, explantation, permanent disability, and death.

Warnings: INSPIRIS RESILIA Aortic Valve - DO NOT ADJUST THE VALVE DIAMETER BY EXPANDING THE BAND PRIOR TO OR DURING IMPLANTATION OF THE SURGICAL VALVE. The expandable band is not designed to allow for compression or expansion during implantation of the surgical valve. This will cause damage to the valve and may result in aortic incompetence. DO NOT PERFORM STAND-ALONE BALLOON AORTIC VALVULOPLASTY PROCEDURES ON THIS VALVE FOR THE SIZES 19 – 25 mm as this may expand the valve causing aortic incompetence, coronary embolism or annular rupture. Valve-in-valve sizing in the INSPIRIS valve has only been tested with specific Edwards transcatheter heart valves. Use of other transcatheter valves may result in embolization of transcatheter devices anchored within or result in annular rupture.

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, COMMENCE, INSPIRIS, INSPIRIS RESILIA, KONECT, KONECT RESILIA, MITRIS, MITRIS 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.