Slide 1: INSPIRIS RESILIA aortic valve Master deck
INSPIRIS RESILIA aortic valve Master deck Version 2.0
Slide 2: Version updates
Version updates § In this version of the INSPIRIS RESILIA aortic valve clinical deck, the following updates have been made: – Up-to-date literature has been added to the section ‘RESILIA tissue and INSPIRIS RESILIA aortic valve literature review’ – Updated table of contents – A new section ‘Annex’ h
Slide 3: Contents
Contents Introduction RESILIA tissue and INSPIRIS RESILIA valve in practice RESILIA tissue and INSPIRIS RESILIA aortic valve literature review References Abbreviations The contents of this slide deck are hyperlinked for your convenience. The hyperlinks are active only in ‘Slide Show’ (full screen) m
Slide 4: Introduction
Introduction BEAN RA iN ave Edwards
Slide 5: Aortic valve replacement in aortic stenosis
Aortic valve replacement in aortic stenosis Surgical AVR is a fundamental intervention for severe aortic stenosis § Improves symptoms and long-term survival1 § Shows good functional improvement and survival, even in elderly patients with comorbidities2,3 Two options for replacement aortic valves are
Slide 6: Guideline recommendations for the treatment of valvular heart disease
Guideline recommendations for the treatment of valvular heart disease Age recommendations based Mechanical on the 2020 ACC/AHA and Mechanical/biological 2021 ESC/EACTS guidelines1,2 Biological 40 45 50 55 60 65 70 75 Age (years) 2020 ACC/AHA and 2020 ACC/AHA guidelines1 2021 ESC/EACTS guidelines2 20
Slide 7: INSPIRIS RESILIA valve builds upon the trusted Carpentier-Edwards PERIMOUNT aortic valve design
INSPIRIS RESILIA valve builds upon the trusted Carpentier-Edwards PERIMOUNT aortic valve design Carpentier-Edwards Carpentier-Edwards Carpentier-Edwards INSPIRIS RESILIA PERIMOUNT valve1 PERIMOUNT Magna PERIMOUNT Magna aortic valve3 Model 2800TFX valve2 Ease valve2 Model 11500A Model 3000* Model 330
Slide 8: PERIMOUNT valve safety and long-term performance assessed in over 30 studies
PERIMOUNT valve safety and long-term performance have been assessed in over 30 studies for up to 25 years of follow-up Bourguignon et al.1 § Valve-related events: low incidence at 20 years N=2,659; mean age: 71 ± 10 years; § Expected valve durability*: 19.7 years mean follow-up: 7 ± 5 years Forcillo
Slide 9: PERIMOUNT Magna and Magna Ease valves' mid-term outcomes in almost 6,000 patients
PERIMOUNT Magna and Magna Ease valves’ mid-term outcomes have been assessed in almost 6,000 patients Anselmi et al.1 § Magna Ease valve freedom from SVD at 5 years: 99 ± 0.5% N=849; mean age: 74 ± 9 years; § PPM in smaller valves is not associated with mid-term mortality mean follow-up: 4 ± 2 years
Slide 10: INSPIRIS RESILIA aortic valve (model 11500A)
INSPIRIS RESILIA aortic valve (model 11500A) RESILIA tissue Commissure post Three independent Design characteristics leaflets § Low profile for patients with a small aortic root § Flexible, cobalt–chromium alloy wireform ‒ Corrosion resistant ‒ Good spring efficiency and fatigue resistance ‒ Covered
Slide 11: RESILIA tissue mitigates residual aldehydes, a key factor in calcification
RESILIA tissue mitigates residual aldehydes, a key factor in calcification § Bovine pericardium treated with Edwards Integrity Preservation technology1 § Reduced tissue calcification enables the valve to be resilient2 Glutaraldehyde stabilisation Integrity preservation technology RESILIA tissue Free
Slide 12: Book a meeting
Book a meeting with an Edwards representative to find out more...
Slide 13: Book a meeting with an Edwards representative
Sg ta. A Siete werd Book a meeting with an Edwards representative to find out more...
Slide 14: Book a meeting with an Edwards representative
Book a meeting with an Edwards representative to find out more...
Slide 15: Book a meeting with an Edwards representative
Book a meeting with an Edwards representative to find out more...
Slide 16: Book a meeting with an Edwards representative
Book a meeting with an Edwards representative to find out more...
Slide 17: References
References Anselmi A, Ruggieri VG, Belhaj Soulami R et al. Hemodynamic results and mid-term follow-up of Carapinha JL, Al-Omar HA, Aluthman U et al. Budget impact analysis of a bioprosthetic valve with a 850 19 to 23 mm PERIMOUNT Magna Ease valves. Thorac Cardiovasc Surg. 2019; 67: 274–81 novel tiss
Slide 18: References (continued)
Foroutan F, Guyatt GH, O’Brien K et al. Prognosis after surgical replacement with a bioprosthetic Keuffel EL, Reifenberger M, Marfo G et al. Long-run savings associated with surgical aortic valve aortic valve in patients with severe symptomatic aortic stenosis: systematic review of observational rep
Slide 19: References (continued)
Meuris B, Torky M, Langenaeken T et al. Innovation in tissue heart valve anti-calcification Singh SSA, Beattie G, Reid D, Curry P. The first INSPIRIS RESILIA aortic valve replacement technology leads to shorter hospital stay in younger adults undergoing aortic valve replacement. (Edwards Lifescience
Slide 20: Abbreviations
Abbreviations ACC: American College of Cardiology ESC: European Society of Cardiology N/A: not applicable AF: atrial fibrillation EuroSCORE: European System NYHA: New York Heart Association AHA: American Heart Association for Cardiac Operative Risk Evaluation PG: pressure gradient AI: aortic insuffi
Slide 21: Important safety information and clinical data notice
No clinical data are available that evaluate the long term impact of RESILIA tissue in patients. 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 115