Edwards Lifesciences Corporation · NYSE:EW
Edwards Lifesciences — Fact Sheet (April 2023)
20 slides from Edwards Lifesciences's fact sheet, April 2023
Slide 1: INSPIRIS RESILIA aortic valve Master deck
INSPIRIS RESILIA aortic valve Master deck Version 1.0
Slide 2: Contents
Contents Introduction RESILIA tissue and INSPIRIS RESILIA valve in practice RESILIA tissue and INSPIRIS RESILIA aortic valve literature review References Abbreviations TKHFRQWHQWVRIWKLVVOLGHGHFNDUHK\SHUOLQNHGIRU\RXUFRQYHQLHQFH7KHK\SHUOLQNVDUHDFWLYHRQO\LQµ6OLGH6KRZ¶ IXOOVFUeen) mode Click on to retur
Slide 3: Introduction
Introduction ai FE ee Edwards
Slide 4: 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 5: 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 6: 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 7: 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 8: PERIMOUNT Magna and Magna Ease valves' mid-term outcomes in almost 6,000 patients
3(5,028170DJQDDQG0DJQD(DVHYDOYHV¶PLG-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 or wor
Slide 9: 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 10: 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 11: Book a meeting with an Edwards representative to find out more
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Slide 16: References
References Anselmi A, Ruggieri VG, Belhaj Soulami R et al. Hemodynamic results and mid-term Borger MA, Dohmen P, Misfeld M and Mohr FW. Current trends in aortic valve follow-up of 850 19 to 23 mm PERIMOUNT Magna Ease valves. Thorac Cardiovasc replacement: Development of the rapid deployment EDWARDS
Slide 17: References (continued)
Forcillo J, El Hamamsy I, Stevens LM et al. The PERIMOUNT valve in the aortic Manzan E, Musumeci F, Glauber M et al. Early and mid-term results from the RESILIA position: Twenty-year experience with patients under 60 years old. Ann Thorac Surg. Aortic Tissue Valve ITAlian Registry (RES-ITA). AATS 10
Slide 18: References (continued)
Salaun E, Clavel M-A, Rodés-Cabau J and Pibarot P. Bioprosthetic aortic valve durability in the era of transcatheter aortic valve implantation. Heart. 2018; 104: 1323±32 Sharabiani MTA, Fiorentino F, Angelini GD, Patel NN. Long-term survival after surgical DRUWLFYDOYHUHSODFHPHQWDPRQJSDWLHQWVRYHU\HD
Slide 19: Abbreviations
Abbreviations ACC: American College of Cardiology LV: left ventricular AF: atrial fibrillation LVEDV: left ventricular end-diastolic volume AHA: American Heart Association LVEF: left ventricular ejection fraction AI: aortic insufficiency MDCT: multidetector computed tomography AR: aortic regurgitati
Slide 20: Important safety information and trademarks
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 WHFKQRORJ\7KHVHIHDWXUHVKDYHQRWEHHQREVHUYHGLQFOLQLFDOVWXGLHVWRHVWDEOLVKWKHVDIHW\DQGHႇHFWLYHQHVVRIWKHPRGHO 11500A for use in valv