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RESILIA tissue surgical valve portfolio

The Edwards Advantage

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(+44).163.527.7334 tech_support_UK@edwards.com
Magna ease
Magna ease
Magna ease

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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 Cardiovasc Surg. 2015;149(1):340-345. 
  2. Beaver T, Bavaria J, Griffith B, et al. Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis. J Thorac Cardiovasc Surg. 2023;x:1-11. 
  3. 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. JTCVS Open. 2023;15:151-163. 
  4. Bartus K, Bavaria J, Thourani V, et al. Structural hemodynamic valve deterioration durability of RESILIA-tissue versus contemporary aortic bioprostheses. J Comp Eff Res. 2023;12(3):e220180. 
  5. Saxon JT, Allen K, Cohen D, et al. Bioprosthetic valve fracture during valve-in-valve TAVR: bench to bedside. Interv Cardiol. 2018;13(1):20-26. 
  6. Saxon JT, Allen K, Cohen D, et al. Complications of bioprosthetic valve fracture as an adjunct to valve-in-valve TAVR. Structural Heart. 2019;3(2):92-99. 
  7. Wang DD, O’Neill B, Caranasos T, et al. Comparative differences of mitral valve-in-valve implantation: A new mitral bioprosthesis versus current mosaic and epic valves. Catheter Cardiovasc Interv. 2022;99(3):934-942.

No clinical data are available that 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.

Refer to device instructions for important warnings related to VFit technology. These features have not been observed in clinical studies to establish the safety and effectiveness of the model 11500A for use in valve-in-valve procedures. VFit technology is available on sizes 19–25 mm.

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).