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The INSPIRIS RESILIA aortic valve

Get closer to the data.

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A closer look at the evidence behind the INSPIRIS RESILIA aortic valve

The INSPIRIS RESILIA aortic valve is backed by a strong and growing base of preclinical and clinical evidence. Edwards Lifesciences are committed to continuing this innovation.

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COMMENCE aortic clinical trial

At 7-year follow-up, RESILIA tissue demonstrated favourable haemodynamic and safety outcomes in the COMMENCE aortic trial1

Aim: To evaluate the safety and effectiveness of a bioprosthetic valve with RESILIA tissue.1,2

Results: At the 7-year follow-up, RESILIA tissue demonstrated:1

195 patients
195 patients
195 patients

The COMMENCE aortic trial is a 10-year prospective, multicentre, single-arm, observation, FDA approved pivotal trial.1,2

Safety outcomes

  • 85.4% freedom from all-cause mortality (95% CI: 82.2, 88.7)
  • 99.3% freedom from SVD (95% CI: 98.3, 100)
  • 97.2% freedom from reoperation (95% CI: 95.5, 99.0) 

Haemodynamic performance

  • Effective orifice area (mean ± SD): 1.82 ± 0.57 cm2
  • Mean pressure gradient(mean ± SD): 9.4 ± 4.5 mmHg

*225 patients re-consented out of the 694 patients initially enrolled at the beginning of the trial. Re-consented cohort had a mean age of 65.1±10.9 years, 76.9% were male, 43% and 19% of patients were classed as NYHA II and III, respectively. 23 or 25 mm valve was implanted in 60.4% of patients.

7-year outcomes from the COMMENCE aortic trial

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

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Read more about the pre-clinical and clinical studies on RESILIA tissue
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Consider the INSPIRIS RESILIA aortic valve for your next SAVR patient

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Visit our resources section for additional information on aortic valve disease and the INSPIRIS RESILIA aortic valve.

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Who is the INSPIRIS RESILIA aortic valve designed for?

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Abbreviations

CI, confidence interval; EOA, effective orifice area; EU, European Union; IDE, investigational device exemption; FDA, United States Food and Drug Administration; MPG, mean pressure gradient; NYHA, New York Heart Association; SAVR, surgical aortic valve replacement; SD, standard deviation; SVD, structural valve deterioration.

References

  1. Beaver T, et al. J Thorac Cardiovasc Surg. 2023;S0022-5223(23)00873–5.
  2. Bavaria JE, et al. Ann Thorac Surg. 2023;115(6):1429-1436.
  3. Sadri V, et al. JTCVS Open. 2021;9:59-69.
  4. Meuris B et al. Presented at 36th European Association for Cardio-Thoracic Surgery Annual Meeting, 2022.
  5. Merius B, et al. J Cardiothorac Surg. 2020;15(1):119. 
  6. Bakhtiary F et al. Presented at 74th Meeting of the Thoracic and cardiovascular surgeons, 2021.
  7. Bakhtiary F, et al. J Cardiothorac Surg. 2021:25;16(1):51. 
  8. Francica A, et al. J Clin Med. 2023;12(5):2077.

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 use 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

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).