RESILIA tissue showed excellent and consistent outcomes over 7 years7
RESILIA tissue data from the COMMENCE aortic trial* show:
99.3%
Freedom from SVD at 7 years*
97.2%
Freedom from re-operation at 7 years*
85.4%
Freedom from all-cause mortality at 7 years
*Includes the following valve sizes: 19 mm, 21 mm, 23 mm, 25 mm, 27 mm, 29 mm.
†*SVD: Structural Valve Deterioration defined as dysfunction or deterioration involving the operated valve (exclusive of infection or thrombosis), as determined by reoperation, autopsy or clinical investigation with periodic echocardiography; SVD refers to valve intrinsic changes, such as wear and tear, fracture, calcification, etc. (Akins et al, 2008). SVD was adjudicated by independent committee.
RESILIA tissue is a transformative calcium-blocking technology*3
RESILIA tissue is the product of nearly 20 years of research and development and used in the INSPIRIS valve, the #1 implanted surgical valve in the US. RESILIA tissue is a proprietary stable capping technology targeting free aldehydes to prevent calcification: the primary driver of structural valve deterioration (SVD) for aortic tissue valves.*3
*No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.
References:
1. Data on file.
2. De la Fuente et al. Advanced Integrity Preservation Technology Reduces Bioprosthesis Calcification While Preserving Performance and Safety. Journal of Heart Valve Disease. 2015.
3. Kodali S et al. Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards SAPIEN valve in the PARTNER trial: characterizing patients and impact on outcomes. Eur Heart J. 2015.
4. Makkar R et al. Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement. N Engl J Med. 2020.
5. Stinis CT, Abbas AE, Teirstein P, et al. Real-World Outcomes for the Fifth-Generation Balloon Expandable Transcatheter Heart Valve in the United States. JACC Cardiovasc Interv. 2024.
6. Flameng W, Hermans H, Verbeken E, et al. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. 2015.
7. Beaver T, Bavaria J, Griffith B, et al. Seven-Year Outcomes Following Aortic Valve Replacement with a Novel Tissue Bioprosthesis. Journal of Thoracic and Cardiovascular Surgery. 2023.
No clinical data are available to evaluate the long-term impact of RESILIA tissue in patients. Additional clinical data for up to 10 years of follow-up are being collected to monitor the long-term safety and performance of RESILIA tissue.
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).