edwards lifesciences 2006 investor...
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Edwards Lifesciences2006 Investor Conference
Edwards Lifesciences2006 Investor Conference
WelcomeWelcome
David K. EricksonVice President, Investor Relations
David K. EricksonVice President, Investor Relations
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Cautionary StatementCautionary Statement
Presentations and comments made today by the management of Edwards Lifesciences Corporation will include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to, the company’s ability to achieve 2006 and 2007 financial goals for sales growth, gross profit margin improvement, net income, EPS and free cash flow; the continued success of recently introduced products and the regulatory approval for additional products in heart valve therapy; the continued adoption and sales of FloTrac and LifeStent; the success of the RESILIENT clinical trial; the timing and progress of clinical studies of, regulatory approvals of, and the market opportunity for transcatheter valve technologies; the impact on valuation and/or financial results of option expensing, foreign exchange and special items. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict.Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward looking statements include the productivity of the R&D pipeline; the strength of the company’s core franchises and their ability to provide a strong platform for sustainable growth; the potential opportunity of the company’s transcatheter valve programs and the ability of the company to continue to lead in the development of this field; and more generally, the ability to obtain regulatory approvals for and market new products; the ability to generate and maintain sufficient cash resources to increase investments in the company’s business and repay debt; the success and timing of new product launches; the impact of currency exchange rates; the timing or results of pending or future clinical trials; actions by the U.S. Food and Drug Administration and other regulatory agencies; technological advances in the medical field; product demand and market acceptance; changing conditions in the economy in general and in the healthcare industry; and other risks detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2005.
Clinician DisclosureClinician Disclosure
The following clinicians are consultants to Edwards Lifesciences and may have received compensation from the company
David H. Adams, M.D.Gary Ansel, M.D.Maurice Buchbinder, M.D.Stephen Clute, M.D.David Ferson, M.D.Barry Katzen, M.D.
John Laird, M.D.Martin B. Leon, M.D. Al Minjock, RNSteve Ramee, M.D.Craig R. Smith, M.D.
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Opening RemarksOpening Remarks
Michael A. MussallemChairman and CEO
Michael A. MussallemChairman and CEO
Key MessagesKey Messages
Edwards Lifesciencesis a global leader in its core business operates in attractive, growing marketsis pursuing exciting new growth opportunitiesis financially stronghas a clear strategy for growth
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Edwards’ Core Business is RobustEdwards’ Core Business is Robust
Heart Valve TherapyStrong market leadership in replacement and repairConversion to tissue continuingUnmatched product pipeline will fuel sustained growth
Critical Care technologies“Gold standard” products in market leading positionsDependable growth and strong customer loyalty
~85% of sales from products with #1 global positionsHigh barriers to entry and strong brand recognition
Edwards’ Core Markets are RobustEdwards’ Core Markets are Robust
Heart Valve DiseaseDemographics will continue to drive incidence Early studies suggest disease is under-treatedTreatments improve life expectancy
Critical Care TechnologyUse is expanding globallyTrained clinicians increasingly in demandSimpler predictive tools are needed
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Edwards is Pursuing Exciting New Growth OpportunitiesEdwards is Pursuing Exciting New Growth Opportunities
Transcatheter aortic replacement substantially expands the heart valve marketFloTrac is expanding hemodynamic monitoringLifeStent will achieve a landmark SFA indication in 2007Transcatheter mitral repair is a large unmet needPursuing advanced technologies to address emerging field of structural heart disease
Edwards is Financially StrongEdwards is Financially Strong
Balanced portfolio of market leading productsMeeting our 2006 financial goalsGross margin expansion continuesStrong balance sheet and cash flowNet income growth continues while increasing investment in R&D and sales channel
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Edwards’ Strategy for Growth is ClearEdwards’ Strategy for Growth is Clear
Remain focused on specific cardiovascular opportunitiesEmphasize differentiated, physician preference products with leadership potential Be a trusted partner Constantly prioritize investments
Recent Business Decisions Sharpen Edwards’ FocusRecent Business Decisions Sharpen Edwards’ Focus
Transferring angiogenesis program to SangamoDiscontinuing Optiwave 980 programTargeted regional exits
Exiting perfusion and mechanical valves internationallyEuropean vascular distribution arrangementU.S. pharmaceutical agreement
Selectively realigning resources Increased investment in advanced technologies
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Environmental Challenges are IncreasingEnvironmental Challenges are Increasing
New product reimbursement pressuresIncreased emphasis on economic value
Rigorous regulatory compliance climateIncreasingly demanding heart valve approval standards
Strategic ImperativesStrategic Imperatives
Increase growth of core heart valve businessLead in transcatheter aortic heart valves Execute on growth opportunitiesStrengthen infrastructure
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Increase Growth of Core Heart Valve BusinessIncrease Growth of Core Heart Valve Business
Surgical heart valve market remains attractive with significant growth opportunities for tissue and repair therapiesEdwards’ product portfolio is unequaled; new products in pipelineInvesting in programs to expand market and enhance surgeon loyalty
Lead in Transcatheter Aortic Heart ValvesLead in Transcatheter Aortic Heart Valves
Opportunities are large and transformationalNew option for currently untreated patientsPotential to increase device content while lowering overall costsStrengthens and further differentiates EdwardsFacilitates mechanical-to-tissue conversion
Complete successful clinical trials
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Execute on Growth OpportunitiesExecute on Growth Opportunities
FloTrac – a market expansion opportunityContinuing adoption will drive additional growthClinical studies will help validate benefits
LifeStent – better technology for an underserved and growing market
Differentiated technologyExpanding sales channel
Advanced Technologies provide longer-term opportunitiesComplementary acquisitions
Strengthen InfrastructureStrengthen Infrastructure
Accelerating new product introductionsEnhancing quality systems Building clinical and reimbursement capabilities to support new technologiesOptimizing product sourcing
Exiting Japan manufacturing facility Building new Singapore heart valve facility
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Management’s Incentives are Aligned with Growth ObjectivesManagement’s Incentives are Aligned with Growth Objectives
Financial goalsRevenue growthNet incomeFree cash flow
Five “Key Operating Drivers”Achieve sales goals for strategic product linesAchieve key R&D, clinical and regulatory milestones
Solid Fundamentals Will Drive Sustainable Financial Performance in 2007Solid Fundamentals Will Drive Sustainable Financial Performance in 2007
2007 Financial Goals: Net sales of $1,075 – $1,125 millionGross profit margin increase of 100 – 150 b.p.Net income growth of 12% – 14%*Free cash flow of $160 – $170 million
*Excludes special items in 2006
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Conference AgendaConference Agenda
Transcatheter Heart Valve Therapy –Perspectives from a Cardiologist and a Surgeon
Martin B. Leon, MDCraig R. Smith, MD
Aortic Transcatheter TechnologiesLarry Wood
Sustaining Growth in Heart Valve TherapyAnita BesslerAlex Martin
Recognizing Undertreatment in Aortic Stenosis David H. Adams, MD
Conference Agenda (cont.)Conference Agenda (cont.)
Growth Opportunities in Critical Care and Peripheral Vascular
Carlyn SolomonKeith Reisinger
Advanced Technologies and Mitral Transcatheter Technologies
Stan RoweDon Bobo
Strengthening Edwards’ Infrastructure and 2007 Financial Outlook
Corinne LyleTom Abate
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Helping Patients is Our LifeHelping Patients is Our Life’’s Work, ands Work, and
Transcatheter Aortic Valve Transcatheter Aortic Valve Replacement: Rationale, Early Replacement: Rationale, Early
Clinical ResultsClinical Results
Martin B. Leon, MDMartin B. Leon, MDColumbia University Medical CenterColumbia University Medical Center
Cardiovascular Research FoundationCardiovascular Research FoundationNew York CityNew York City
Edwards Lifesciences Investor MeetingEdwards Lifesciences Investor MeetingDecember 8, 2006December 8, 2006
New York CityNew York City
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Consultant or Advisory Board:Edwards Lifesciences (non-paid)Consultant or Advisory Board:Consultant or Advisory Board:Edwards Lifesciences (nonEdwards Lifesciences (non--paid)paid)
Presenter Disclosure InformationPresenter Disclosure Informationfor this presentationfor this presentation……
Martin B. Leon, M.D.Martin B. Leon, M.D.
Predicting the FuturePredicting the Future
TranscatheterTranscatheterAVR is the AVR is the
MOST EXCITINGMOST EXCITINGnew procedure in the new procedure in the field of interventional field of interventional
cardiovascular cardiovascular therapeutics!!!therapeutics!!!
Transcatheter AVR Transcatheter AVR
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Transcatheter Aortic Valve ReplacementTranscatheter Aortic Valve Replacement
92 92 yoyo man withman withcritical AScritical AS……Treated at CUMCTreated at CUMCon 2/8/06on 2/8/06……Playing golf in Playing golf in Palm Springs onPalm Springs on3/8/06!!!3/8/06!!!
Patient #1Patient #1
RationaleRationale……(why are we doing (why are we doing
this?)this?)
Transcatheter AVR Transcatheter AVR
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“Surgical intervention should be performed promptly
once even … minor
symptoms occur”
““Surgical Surgical intervention intervention should be should be performed performed promptly promptly
once even once even …… minor minor
symptoms symptoms occuroccur””
40 50 60 70 800
20
40
60
80
100
AgeYears
SurvivalPercent Onset severe
symptoms
6420Avg. survivalYears
AnginaSyncope
Failure
Latent Period (Increasing Obstruction, Myocardial Overload)
Severely Symptomatic PatientsSeverely Symptomatic PatientsRequire Urgent AttentionRequire Urgent AttentionValvular Aortic Stenosis In Adults Valvular Aortic Stenosis In Adults
(Average Course)(Average Course)
Sources: Ross J Sources: Ross J JrJr, , BraunwaldBraunwald E. Aortic stenosis. E. Aortic stenosis. CirculationCirculation 1968;38 (1968;38 (SupplSuppl 1) 1) C.M. Otto. Valve Disease: Timing of Aortic Valve Surgery. HeartC.M. Otto. Valve Disease: Timing of Aortic Valve Surgery. Heart 2000.2000.
•• Symptomatic patients with severe AS Symptomatic patients with severe AS (Class I(Class I--B)B)
•• Patients with severe AS undergoing CABG Patients with severe AS undergoing CABG (Class I(Class I--C)C)
•• Patients with severe AS undergoing Patients with severe AS undergoing AoAo or or other heart valve surgery (Class Iother heart valve surgery (Class I--C)C)
•• Patients with severe AS and LV systolic Patients with severe AS and LV systolic dysfunction dysfunction -- EF<50% (Class IEF<50% (Class I--C)C)
•• Patients with moderate AS undergoing CABG, Patients with moderate AS undergoing CABG, or or AoAo, or other heart valve surgery , or other heart valve surgery (Class (Class IIaIIa--B)B)
Transcatheter AVRTranscatheter AVRIndications for Surgical AVRIndications for Surgical AVRIndications for Surgical AVR
Why is surgical AVR so great?Why is surgical AVR so great?
Because our patients…1. Live longer2. Feel better (marked Sx benefit)3. Have improved LV function
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Natural History of Aortic StenosisNatural History of Aortic Stenosis
0
20
40
60
80
100
40 50 60 70 80Age (years)Age (years)
Sur
viva
l (pe
rcen
t)S
urvi
val (
perc
ent) Increasing obstruction,
myocardial overload
Average Age DeathAverage Age Death
Latent Period
SymptomsSymptoms
from Ross and from Ross and BraunwaldBraunwald, Circulation 1968, Circulation 1968
The Potential Population of AS Pts The Potential Population of AS Pts Requiring TreatmentRequiring Treatment
232,833,408232,833,40817,830,51317,830,51318,463,47218,463,47229,078,92429,078,92441,618,80541,618,805
125,841,694125,841,694
2004 Population2004 Population
––4.60%4.60%1.40%1.40%0.60%0.60%0.20%0.20%0.10%0.10%
AS AS PrevalencePrevalence
487,415487,415273,401273,40186,16386,16358,15858,15827,74627,74641,94741,947
Severe Severe ASAS
243,708243,708TotalTotal
43,08143,0816565--7474
13,87313,8734545--5454
136,701136,701>75>75
29,07929,0795555--6464
20,97420,9741818--4444
Severe AS Severe AS 50% with 50% with SxSx
Based upon the Olmsted County AS prevalence data Based upon the Olmsted County AS prevalence data and US and US poplulationpoplulation statistics;statistics; more than half of the more than half of the
severe AS patients are >75 years old!severe AS patients are >75 years old!
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CURRENTCURRENT Candidates for Candidates for Transcatheter AVRTranscatheter AVR
UnreferredUnreferredUnreferred
Severe ASSevere ASSevere AS
High Surgical RiskHigh Surgical RiskHigh Surgical Risk
symptomaticsymptomatic> 70 > 70 yoyo
High Risk AVRHigh Risk AVRHigh Risk AVR
CURRENTCURRENT Candidates for Candidates for Transcatheter AVRTranscatheter AVR
UnreferredUnreferredUnreferred
Severe ASSevere ASSevere AS
High Surgical RiskHigh Surgical RiskHigh Surgical Risk
symptomaticsymptomatic> 70 > 70 yoyo
High Risk AVRHigh Risk AVRHigh Risk AVR
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SEVERE AS SEVERE AS PatientsPatients
AORTIC VALVE AORTIC VALVE REPLACEMENT REPLACEMENT
SURGERYSURGERY
SURGEONS view of the SURGEONS view of the aortic aortic stenosisstenosis populationpopulation
We operate onWe operate onEverybody!Everybody!
31.8% did not undergo intervention, despite NYHA
class III/IV symptoms
Do patients with Do patients with valvularvalvular heart disease receive heart disease receive treatment according to established guidelines?treatment according to established guidelines?
•• 92 92 hospitalshospitals fromfrom 25 countries25 countries•• 5,001 patients 5,001 patients fromfrom AprilApril--July, 2001July, 2001
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Aortic Stenosis ≥ 75 yearsN=408
No Severe AS(n=114)
Severe AS(n=284)
No SymptomsN=68
SymptomsN=216
InterventionN=144 (67%)
No InterventionN=72 (33%)
NYHA III :106
NYHA IV : 36
Angina : 148
IungIung, B, et al. , B, et al. EurEur HeartHeart J 2005;26:2714J 2005;26:2714--2020
Euro Euro HeartHeart SurveySurveySymptomaticSymptomatic AS (AS (elderlyelderly))
Loma Linda Echo Study Loma Linda Echo Study in Patients with Severe ASin Patients with Severe AS
•• EchocardiographyEchocardiography perspective of all screened patients perspective of all screened patients between between 19931993--20032003
•• 740 patients740 patients identified with identified with severe ASsevere AS (AVA (AVA ≤≤ 0.8cm0.8cm22))•• 457 did not undergo AVR 457 did not undergo AVR –– 62%62%•• AVR was not offeredAVR was not offered in many of the patients with severe in many of the patients with severe
AS for various reasons: AS for various reasons: clinical coclinical co--morbidities, morbidities, ““lack of lack of symptomssymptoms””, or , or ““patient refusalpatient refusal””
•• Medically managed severe AS patients have a dismal Medically managed severe AS patients have a dismal prognosis (1,5 and 10 yr prognosis (1,5 and 10 yr survivialsurvivial = 60, 32, and 18%)= 60, 32, and 18%)
•• Independent risk factors for higher mortality includeIndependent risk factors for higher mortality includeAdvanced age, low ejection fraction , CHF, PHT, 3Advanced age, low ejection fraction , CHF, PHT, 3--4+ MR 4+ MR and CRI and CRI
PaiPai RG et. al. RG et. al. EurEur J J CardioThoracCardioThorac Surgery 2006Surgery 2006
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U of Michigan Echo Study U of Michigan Echo Study in Patients with Severe ASin Patients with Severe AS
CourtesyCourtesy of David Bach; U of Michiganof David Bach; U of Michigan
Echo Echo severesevere ASASN=145*N=145*
2005 U of Michigan andMichigan Heart & Vascular
AVRAVR(n=73)(n=73)
NO AVRNO AVR(n=68)(n=68)
* 4 pts not felt to be severe AS clinically* 4 pts not felt to be severe AS clinically
•• 84% co84% co--morbidities (67% multiple)morbidities (67% multiple)•• 40% previous cardiac surgery40% previous cardiac surgery•• 34% asymptomatic 34% asymptomatic
FU FU meanmean 206 206 ++ daysdays::16 pts 16 pts dieddied (24%)(24%)
(47%)(47%)
The Potential Population of AS Pts The Potential Population of AS Pts Requiring TreatmentRequiring Treatment
232,833,408232,833,40817,830,51317,830,51318,463,47218,463,47229,078,92429,078,92441,618,80541,618,805
125,841,694125,841,694
2004 Population2004 Population
––4.60%4.60%1.40%1.40%0.60%0.60%0.20%0.20%0.10%0.10%
AS AS PrevalencePrevalence
487,415487,415273,401273,40186,16386,16358,15858,15827,74627,74641,94741,947
Severe Severe ASAS
243,708243,708TotalTotal
43,08143,0816565--7474
13,87313,8734545--5454
136,701136,701>75>75
29,07929,0795555--6464
20,97420,9741818--4444
Severe AS Severe AS 50% with 50% with SxSx
Based upon the Olmsted County AS prevalence data Based upon the Olmsted County AS prevalence data and US and US poplulationpoplulation statistics,statistics, the potential AS the potential AS
treatment cohort could exceed 250,000 patients!treatment cohort could exceed 250,000 patients!
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Projected AVR Procedures (US)Projected AVR Procedures (US)
66,980 69,768 72,619
59,263 61,658 64,196
0
10,000
20,000
30,000
40,000
50,000
60,000
70,000
80,000
2005 2006 2007 2008 2009 2010
# Im
plan
ts#
Impl
ants
CURRENTCURRENT Candidates for Candidates for Transcatheter AVRTranscatheter AVR
UnreferredUnreferredUnreferred
Severe ASSevere ASSevere AS
High Surgical RiskHigh Surgical RiskHigh Surgical Risk
symptomaticsymptomatic> 70 > 70 yoyo
High Risk AVRHigh Risk AVRHigh Risk AVR
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High RiskHigh Risk AVR PatientsAVR Patientswith Poor Outcomeswith Poor Outcomes
•• Radiation chest wall/heart diseaseRadiation chest wall/heart disease•• Octogenarians with multiple coOctogenarians with multiple co--morbiditiesmorbidities•• STS Predicted Risk >8%, Logistic STS Predicted Risk >8%, Logistic
EuroSCOREEuroSCORE >30% (~10% operative risk)>30% (~10% operative risk)•• Cirrhosis with portal hypertensionCirrhosis with portal hypertension•• ESRD on dialysisESRD on dialysis•• Porcelain aortaPorcelain aorta•• Degenerative Degenerative neurocognitiveneurocognitive dysfunction dysfunction
There is no perfect formula! There is no perfect formula! Requires some quantitative risk algorithmRequires some quantitative risk algorithm
+ a thoughtful surgeon/cardiologist!!! + a thoughtful surgeon/cardiologist!!!
Early Clinical Early Clinical ResultsResults……
Transcatheter AVR Transcatheter AVR
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Transcatheter AVR Transcatheter AVR
TranscatheterAVR
TranscatheterTranscatheterAVRAVR
Trans-femoral (cath lab)
TransTrans--femoral femoral ((cathcath lab)lab)
Trans-apical(OR)
TransTrans--apicalapical(OR)(OR)
•• Antegrade = femoral Antegrade = femoral veinvein
•• Retrograde = femoral Retrograde = femoral arteryartery
Transcatheter AVRTranscatheter AVR
TranscatheterAVR
TranscatheterTranscatheterAVRAVR
Trans-femoral (cath lab)
TransTrans--femoral femoral ((cathcath lab)lab)
24
CribierCribier--Edwards Aortic Edwards Aortic BioprosthesisBioprosthesisEnrollment (2002Enrollment (2002--06) 06)
282 282 Cases*Cases*
AntegradeAntegrade(n=59)(n=59)
RetrogradeRetrograde(n=143)(n=143)
TransTrans--apicalapical(n=80)(n=80)
40 Rouen40 Rouen7 US7 US
12 other OUS12 other OUS
59 Vancouver59 Vancouver54 US54 US
30 other OUS30 other OUS
19 Vancouver19 Vancouver38 Leipzig38 Leipzig21 Vienna21 Vienna2 Dallas2 Dallas
* Updated October 16, 2006* Updated October 16, 2006
Embolized valve 2Embolized valve 2Embolized valve 2
St. PaulSt. Paul’’s Hospital Vancouver Experiences Hospital Vancouver Experience
Unable to deliver/cross 5Unable to deliver/cross 5Unable to deliver/cross 5
80 Patients80 Patients80 Patients
58 Femoral58 Femoral58 Femoral 22 Apical22 Apical22 Apical
Successful Deployment
51
Successful Successful DeploymentDeployment
5151
Unsuccessful Deployment
7
Unsuccessful Unsuccessful DeploymentDeployment
77
Successful Deployment
18
Successful Successful DeploymentDeployment
1818
3030--day mortality: 12.1%day mortality: 12.1%3030--day stroke: 3.4% day stroke: 3.4% Logistic Logistic EuroSCOREEuroSCORE: 28%: 28%
J. Webb and colleagues
ImplantImplantsuccess: 88%success: 88%
25
Vancouver RegistryVancouver RegistryAortic Valve Area (TTE, n=50 femoral)Aortic Valve Area (TTE, n=50 femoral)
Baseline Post 1 Month 6 month 12 monthBaseline Post 1 Month 6 month 12 month
0.6
1.7 1.6 1.6 1.6
AVA
(CM
AVA
(CM
22 ))Echo Assessments of Valve PerformanceEcho Assessments of Valve Performance
Preliminary Results from the Preliminary Results from the PePeRRcutaneouscutaneous EEndondoVVascularascular
IImplantation of mplantation of VALVALvesves Trial in Trial in High Risk Patients with Critical High Risk Patients with Critical
Aortic StenosisAortic Stenosis
SusheelSusheel K. K. KodaliKodali, William O, William O’’Neill, Neill, Jeffrey W. Moses, Jeffrey W. Moses, SamirSamir KapadiaKapadia, , Mathew Williams, George Mathew Williams, George HanzelHanzel, ,
Allan Stewart, Murat Allan Stewart, Murat TuzcuTuzcu, Michael , Michael Collins, and Martin B. LeonCollins, and Martin B. Leon
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Malpositioned valve 1MalpositionedMalpositioned valve 1valve 1
US Retrograde US Retrograde CribierCribier--Edwards ExperienceEdwards Experience
Unable to cross 3Unable to cross 3Unable to cross 3
55 Patients*55 Patients*55 Patients*
Trans-femoral55
TransTrans--femoralfemoral5555
Unsuccessful Deployment
7
Unsuccessful Unsuccessful DeploymentDeployment
77
3030--day Mortality: 7.3% (4) day Mortality: 7.3% (4) 3030--day MACCE: 16.4% (9) day MACCE: 16.4% (9) Logistic Logistic EuroSCOREEuroSCORE: 33%: 33%STS score: 13%STS score: 13%
PI: Wm OPI: Wm O’’NeillNeill
Centers:Centers:29 Columbia29 Columbia15 Beaumont 15 Beaumont 11 Cleveland 11 Cleveland
ClinicClinic
REVIVAL IIREVIVAL II
* Updated October 16, 2006* Updated October 16, 2006
Failed access 3Failed access 3Failed access 3
ImplantImplantsuccess: 87%success: 87%
Successful Deployment
48
Successful Successful DeploymentDeployment
4848
REVIVAL IIREVIVAL IIPatient Characteristics (n=54)Patient Characteristics (n=54)
20.4% (11)20.4% (11)≥≥ 90 years90 years
63.0% (34)63.0% (34)≥≥ 80 years80 years
53% 53% ±± 16%16%Ejection Fraction (echo)Ejection Fraction (echo)
53.7% (29)53.7% (29)FemaleFemale
33.3 33.3 ±± 17.3 (517.3 (5--83)83)EuroSCOREEuroSCORE (%)(%)
2.05 2.05 ±± 0.67 (10.67 (1--3) 3) PrePre--AR grade (echo)AR grade (echo)0.59 0.59 ±± 0.12 (0.4 0.12 (0.4 -- 0.81)0.81)PrePre--AVA (cmAVA (cm22 –– echo)echo)
13.0 13.0 ±± 7.1 (47.1 (4--31)31)STS score (%)STS score (%)
82.4 82.4 ±± 6.4 (696.4 (69--100) 100) Age (yrs)Age (yrs)
27
REVIVAL IIREVIVAL IIHigh Risk CoHigh Risk Co--morbiditiesmorbidities
9.3% (5)9.3% (5)Severe COPDSevere COPD3.7% (2)3.7% (2)CirrhosisCirrhosis
7.4% (4)7.4% (4)Chest wall radiationChest wall radiation14.8% (8)14.8% (8)Renal failure Renal failure (Cr > 2.0)(Cr > 2.0)
9.2% (5)9.2% (5)Porcelain aortaPorcelain aorta25.9% (14)25.9% (14)Peripheral vascular diseasePeripheral vascular disease40.7% (22)40.7% (22)Prior CABGPrior CABG
37.5% (20)37.5% (20)10% (5)10% (5)
Impaired LVEF <40%Impaired LVEF <40%<30%<30%
76% (41)76% (41)NYHA Class III/IV (CHF) NYHA Class III/IV (CHF)
Unable to cross - 3Unable to cross Unable to cross -- 33
REVIVAL IIREVIVAL IIProcedural ResultsProcedural Results
54 Patients Enrolled
54 Patients 54 Patients EnrolledEnrolled
Successful Deployment
47
Successful Successful DeploymentDeployment
4747
Unsuccessful Deployment
7
Unsuccessful Unsuccessful DeploymentDeployment
77
Failed access - 3Failed access Failed access -- 33
Implant Success Implant Success 87.0%87.0%
23 mm Valve(18)
23 mm 23 mm ValveValve(18)(18) Malplacement - 1MalplacementMalplacement -- 11
26mm Valve(29)
26mm 26mm ValveValve(29)(29)
61.7%38.3%
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REVIVAL IIREVIVAL IIMean AV Gradients (n=42 pts)Mean AV Gradients (n=42 pts)
0
10
20
30
40
50
60
70
80
Pre Post
Mea
n G
radi
ent
P<0.0001
Measured post-PHV placement in cath lab
REVIVAL IIREVIVAL II –– Clinical OutcomesClinical Outcomes
5 (9.2%)5 (9.2%)5 (9.2%)5 (9.2%)5 (9.2%)5 (9.2%)NeurologicNeurologic eventsevents
2 (5.5%)*2 (5.5%)*2 (5.5%)*2 (5.5%)*2 (5.5%)*2 (5.5%)*Renal failure (Renal failure (reqreq dialysis)dialysis)7 days7 daysMedian hospital stayMedian hospital stay
000000Device migration (postDevice migration (post--proc)proc)1 (1.8%)1 (1.8%)7 (13.0%)7 (13.0%)
00
0 0 4 (7.4%)4 (7.4%)
9 (16.7%)9 (16.7%)
30 Day30 Day
2 (3.7%)2 (3.7%)7 (13.0%)7 (13.0%)
00
0 0 8 (14.8%)8 (14.8%)
13 (24.1%)13 (24.1%)
> 30 Days> 30 DaysInIn--HospitalHospital
OtherOther
007 (13.0%)7 (13.0%)
00
0 0 4 (7.4%)4 (7.4%)
9 (16.7%)9 (16.7%)MACCEMACCE
Repeat balloon dilatationRepeat balloon dilatationVascular complicationVascular complication
MIMIDeathDeath
ReopReop for valve failurefor valve failure
* One patient on CVVHD prior to valve implantation* One patient on CVVHD prior to valve implantation
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REVIVAL IIREVIVAL IIPatient DeathsPatient Deaths
Liver failureLiver failure102 102 7/87/876 F76 F
Acute abdomen with shockAcute abdomen with shock15815837/1137/1183 F83 F
CHF (failure to cross)CHF (failure to cross)565614/5514/5577 M77 M
4141
1414
33
11
00
Day #Day #
HyperosmolarHyperosmolar coma and renal failurecoma and renal failure21/2821/2891 F91 F
CHF and renal failure (failed access + CHF and renal failure (failed access + vascular complications)vascular complications)
13/7313/7391 F91 F
Ascending aortic dissection Ascending aortic dissection (failure to cross)(failure to cross)
13.3/ 5213.3/ 5292 F92 F
Ascending aortic dissection Ascending aortic dissection (failure to cross)(failure to cross)
7/ 207/ 2069 M69 M
MalplacementMalplacement of valve with severe AR of valve with severe AR and shockand shock
26/ 6026/ 6085 M85 M
CauseCauseSTS/STS/EuroSCOREEuroSCOREAge/GenderAge/Gender
outout--ofof--hospitalhospital
REVIVAL IIREVIVAL IIVascular and Vascular and NeuroNeuro ComplicationsComplications
3 (5.6%)3 (5.6%)Minor StrokeMinor Stroke
1 (1.8%)1 (1.8%)SubarachnoidSubarachnoid HemorrhageHemorrhage
1 (1.8%)1 (1.8%)Major StrokeMajor Stroke
NeurologicNeurologic EventEvent
2 (3.7%)2 (3.7%)Unplanned Unplanned IliofemoralIliofemoral bypass graftbypass graft
5 (9.2%)5 (9.2%)Iliac PerforationIliac Perforation
VascularVascular
30
REVIVAL IIREVIVAL IINYHA Class (to 3 months)NYHA Class (to 3 months)
0
0.5
1
1.5
2
2.5
3
3.5
4
44 34 17
Baseline 30 days 3 months
NYH
A
n
P < 0.05
REVIVAL IIREVIVAL IILV Function LV Function -- Echo (n=27)Echo (n=27)
Ejection Fraction
48.653.3
0.0
10.0
20.0
30.0
40.0
50.0
60.0
70.0
%
Baseline30 Days
P<0.01P<0.01
31
REVIVAL IIREVIVAL IIImprovement in LV Function (n=27)Improvement in LV Function (n=27)
Baseline EF < 50%
01020304050607080
Baseline 30 Days
EF (%
)
P < 0.01P < 0.01
Echo ResultsEcho Results
REVIVAL IIREVIVAL II -- Aortic Regurgitation Aortic Regurgitation (n=21)(n=21)
None
Mild
Moderate
Trace
Mod-Severe
Severe
4
4
9
4
12
1
2
11
3
6
3
1
2
8
9
2
Pre Post
32
•• Improved valve implant success (87%)Improved valve implant success (87%)•• Excellent immediate valve performance (minimal Excellent immediate valve performance (minimal
AV gradients and no severe AR)AV gradients and no severe AR)•• Acceptable inAcceptable in--hospital clinical outcomes (mortality hospital clinical outcomes (mortality
7.4% and MACCE 16.6%)7.4% and MACCE 16.6%)•• Frequent vascular and neurological complications Frequent vascular and neurological complications
(13.0 % and 9.2% respectively)(13.0 % and 9.2% respectively)
REVIVAL IIREVIVAL IIConclusions Conclusions --11
Preliminary results of transcatheter AVR using the Preliminary results of transcatheter AVR using the CribierCribier--Edwards PHV, via Edwards PHV, via transfemoraltransfemoral retrograde retrograde access, in elderly patients at high risk for access, in elderly patients at high risk for conventional AVR, indicate:conventional AVR, indicate:
•• Improved LV function at 30 daysImproved LV function at 30 days•• Improved symptoms up to 3 monthsImproved symptoms up to 3 months•• Continued excellent valve performance up to 3 Continued excellent valve performance up to 3
monthsmonths•• No valveNo valve--related late cardiac deathsrelated late cardiac deaths
REVIVAL IIREVIVAL IIConclusions Conclusions -- 22
Clearly, longer term followClearly, longer term follow--up is required to assess up is required to assess valve durability. A valve durability. A multicentermulticenter U.S. pivotal U.S. pivotal randomized clinical trial is being planned to assess randomized clinical trial is being planned to assess the value of this new the value of this new tAVRtAVR therapy in high risk therapy in high risk patients with critical AS. patients with critical AS.
33
Retrograde TranscatheterRetrograde TranscatheterAVR at CUMCAVR at CUMC
A unique collaborative effort!A unique collaborative effort!
•• interventional cardiologistsinterventional cardiologists•• endovascular therapistsendovascular therapists•• cardiac surgeonscardiac surgeons•• vascular surgeonsvascular surgeons•• cardiac anesthesiologistscardiac anesthesiologists•• echocardiographersechocardiographers•• angioplasty assistantsangioplasty assistants•• dedicated nursing staffdedicated nursing staff•• research nurse coordinatorsresearch nurse coordinators•• industry specialists industry specialists
•• 100 100 yoyo Holocaust survivorHolocaust survivor•• critical AS (AVA 0.2 cmcritical AS (AVA 0.2 cm22), ), CAD CAD s/ps/p CABG, PAH, CRI, andCABG, PAH, CRI, andclass IV CHF; class IV CHF; EuScEuSc (log) 49%,(log) 49%,STS 29%STS 29%
•• 23mm 23mm CribierCribier--Edwards PHV,Edwards PHV,retrograde without retrograde without complicscomplics
•• Discharge POD #3Discharge POD #3•• Continues to do well Continues to do well -- markedmarkedlifestyle improvement!!!lifestyle improvement!!!
POD #1
POD #3
Transcatheter AVRTranscatheter AVRCase Example: CUMC (Aug 2006)Case Example: CUMC (Aug 2006)
34
Final Thoughts - 1Final Thoughts Final Thoughts -- 11
•• There is a There is a clear unmet clinical needclear unmet clinical need –– many many patients with severe AS are poorly served with patients with severe AS are poorly served with either surgery or medical therapy. either surgery or medical therapy.
•• Transcatheter AVRTranscatheter AVR has been performed in has been performed in almost 300 pts worldwide and almost 300 pts worldwide and proofproof--ofof--concept concept has been validatedhas been validated for the retrograde transfor the retrograde trans--femoral and the femoral and the antegradeantegrade transtrans--apical apical approachesapproaches…… pivotal pivotal RCTsRCTs are on the verge of are on the verge of beginning in the U.S.!beginning in the U.S.!
Transcatheter AVR Transcatheter AVR
Transapical Surgical Delivery Transapical Surgical Delivery of the of the
CribierCribier--Edwards Aortic Edwards Aortic BioprosthesisBioprosthesis
-- Worldwide Clinical Experience Worldwide Clinical Experience --
Craig R. Smith, MDCraig R. Smith, MDChief, Cardiothoracic SurgeryChief, Cardiothoracic Surgery
Columbia University Medical CenterColumbia University Medical Center
Edwards LifesciencesEdwards LifesciencesInvestor ConferenceInvestor ConferenceDecember 8, 2006December 8, 2006
35
Transapical Surgical Aortic Valve Replacement of the Transapical Surgical Aortic Valve Replacement of the CribierCribier--EdwardsEdwards Aortic Bioprosthesis Aortic Bioprosthesis
The first sternal sparing, offThe first sternal sparing, off--pump/beating heart procedure pump/beating heart procedure targeting high risk patientstargeting high risk patients
Transapical Access
•• Minimal access incision between the ribsMinimal access incision between the ribs
•• Designed to improve clinical outcomesDesigned to improve clinical outcomes
•• Intended to shorten procedure and Intended to shorten procedure and recovery times recovery times
•• Aim to reduce hospital length of stayAim to reduce hospital length of stay
•• Potential to expand the market for valve Potential to expand the market for valve surgery by treating patients not treated surgery by treating patients not treated todaytoday
CribierCribier--EdwardsEdwards Aortic Bioprosthesis and Aortic Bioprosthesis and AscendraAscendraTMTM Transapical Valve Delivery SystemTransapical Valve Delivery System
CribierCribier--Edwards aortic bioprosthesisEdwards aortic bioprosthesis::•• Frame: Balloon expandable stainless Frame: Balloon expandable stainless
steel stent for sutureless implantationsteel stent for sutureless implantation•• Valve: Valve: TrileafletTrileaflet bovine pericardial bovine pericardial
tissue leaflets treated with ThermaFixtissue leaflets treated with ThermaFix™™processprocess
AscendraAscendra™™ valve delivery systemvalve delivery system::•• Balloon catheter system for direct Balloon catheter system for direct
ventricular transapical accessventricular transapical access•• Introducer sheath for direct ventricular Introducer sheath for direct ventricular
transapical access transapical access •• Designed for ease of use and timely Designed for ease of use and timely
aortic valve implantation aortic valve implantation
36
Transapical Surgical Aortic Valve Replacement: Transapical Surgical Aortic Valve Replacement: Procedural StepsProcedural Steps
4) Valve fully deployed3) Valve deployed over a guidewire using balloon catheter into native aortic annulus
1) Small incision between the 5th & 6th ribs of the left chest wall
2) Introducer sheath placed through apex & balloon valvuloplasy performed
CribierCribier--Edwards Edwards TransapicalTransapical Surgery Surgery Clinical ExperienceClinical Experience
•• Clinical indication for the transapical Clinical indication for the transapical approach = high risk surgical patients approach = high risk surgical patients who have one or more of the following:who have one or more of the following:
Significant cardiac & nonSignificant cardiac & non--cardiac cardiac comorbiditiescomorbiditiesContraindication for open chest Contraindication for open chest procedureprocedureAortic arch and thoracic aorta diseaseAortic arch and thoracic aorta diseaseSmall, tortuous, calcified iliofemoral Small, tortuous, calcified iliofemoral vesselsvessels
37
CribierCribier--EdwardsEdwards Transapical Surgery Transapical Surgery Clinical ExperienceClinical Experience
Participating SitesParticipating Sites
CenterCenter CliniciansCliniciansEUROPE EUROPE –– Feasibility Trial Feasibility Trial –– 72 pts (Nov 2006)72 pts (Nov 2006)
Heart Center Leipzig, Leipzig, GermanyHeart Center Leipzig, Leipzig, Germany Professor Professor Dr. F. MohrDr. F. MohrProfessor Dr. T. WaltherProfessor Dr. T. Walther
JWG University Clinics, Frankfurt, GermanyJWG University Clinics, Frankfurt, Germany Professor Dr. G. WimmerProfessor Dr. G. Wimmer--GreineckerGreineckerDr. M. DossDr. M. Doss
AKH/Medical University Vienna, Austria Professor Dr. E.AKH/Medical University Vienna, Austria Professor Dr. E. WolnerWolnerProfessor Dr. P. SimonProfessor Dr. P. Simon
CANADA CANADA –– Special Access Special Access -- 20 pts (Nov 200620 pts (Nov 2006))St. PaulSt. Paul´́s Hospital, Vancouver, BC, Canadas Hospital, Vancouver, BC, Canada Dr. S. LichtensteinDr. S. Lichtenstein
Dr. A. Cheung, Dr. J. YeDr. A. Cheung, Dr. J. Ye
US US –– Compassionate Use Compassionate Use -- 2 pts (Nov 2006)2 pts (Nov 2006)Medical City Dallas, Dallas, Texas, USAMedical City Dallas, Dallas, Texas, USA Dr. Todd DeweyDr. Todd Dewey
Dr. Michael MackDr. Michael Mack
CribierCribier--EdwardsEdwards TransapicalTransapical Surgery Surgery EuropeanEuropean Clinical ExperienceClinical Experience
•• Interim Analysis (Oct. 2006): 44 patients enrolled through Aug. Interim Analysis (Oct. 2006): 44 patients enrolled through Aug. 20062006
•• DemographicsDemographicsMean Age: 80.6 yrs Mean Age: 80.6 yrs Female: 79.5% Female: 79.5% Mean logistic Euroscore: 24.3%Mean logistic Euroscore: 24.3%NYHA Class III: 56.8%; Class IV: 43.2%NYHA Class III: 56.8%; Class IV: 43.2%
•• ResultsResultsExplants: 15.9% (7)Explants: 15.9% (7)
•• Perivalvular leaks: 13.6% (6)Perivalvular leaks: 13.6% (6)Overall Mortality Overall Mortality
•• Early Mortality Early Mortality << 30 days: 11.3% (5) (1 valve related)30 days: 11.3% (5) (1 valve related)•• Late Mortality: 11.3% (5) (0 valve related)Late Mortality: 11.3% (5) (0 valve related)
Significant improvement in mean gradients at dischargeSignificant improvement in mean gradients at discharge•• Preop: mean 45.88 Preop: mean 45.88 ±± 16.91 mmHg16.91 mmHg•• Discharge: mean 10.54 Discharge: mean 10.54 ±± 7.08 mmHg7.08 mmHg
38
Key Considerations for Transapical Surgical Key Considerations for Transapical Surgical Aortic Valve ReplacementAortic Valve Replacement
•• MultiMulti--disciplinary coordinated team approach optimal for 1disciplinary coordinated team approach optimal for 1stst
generation technology & proceduregeneration technology & procedure
•• Surgeons can be readily trained to perform transapical Surgeons can be readily trained to perform transapical procedure, but there will be a learning curveprocedure, but there will be a learning curve
•• Visualization is critical for procedural success Visualization is critical for procedural success -- valve valve placement requires high quality placement requires high quality echocardiographicechocardiographic and and fluoroscopic imaging fluoroscopic imaging
Hybrid OR provides best environmentHybrid OR provides best environment
•• Future standard of care for many high risk surgical patientsFuture standard of care for many high risk surgical patients
SEVERE AORTIC STENOSIS
AORTIC VALVE REPLACEMENT SURGERY
BALLOON AORTIC VALVULOPLASTY
REFUSALS
“MEDICAL THERAPY”
“ASYMPTOMATIC”
Valve Surgery Market Expansion MapValve Surgery Market Expansion Map
HIGH-RISKPATIENTS
39
SEVERE AORTIC STENOSIS
AORTIC VALVE REPLACEMENT SURGERY
BALLOON AORTIC VALVULOPLASTY
REFUSALS
“MEDICAL THERAPY”
“ASYMPTOMATIC”
Mapping TCAVR: The present and PARTNERMapping TCAVR: The present and PARTNER
HIGH-RISKPATIENTS
TCAVR
At Columbia, availability of At Columbia, availability of TransfemoralTransfemoral has:has:
•• Generated AVR referrals from Generated AVR referrals from TransfemoralTransfemoral
•• Generated Generated TransfemoralTransfemoral referrals from AVRreferrals from AVR
•• NNet result: Modest growth in bothet result: Modest growth in both
40
SEVERE AORTIC STENOSIS
AORTIC VALVE REPLACEMENT SURGERY
BALLOON AORTIC VALVULOPLASTY
REFUSALS
“MEDICAL THERAPY”
“ASYMPTOMATIC”
Mapping TCAVR: ShortMapping TCAVR: Short--term impact on AVRterm impact on AVR
HIGH-RISKPATIENTS
TCAVR
SEVERE AORTIC STENOSIS
AORTIC VALVE REPLACEMENT SURGERY
BALLOON AORTIC VALVULOPLASTY
REFUSALS
“MEDICAL THERAPY”
“ASYMPTOMATIC”
The Future: Worst CaseThe Future: Worst Case
HIGH-RISKPATIENTS
TCAVR
41
SEVERE AORTIC STENOSIS
AORTIC VALVE REPLACEMENT SURGERY
BALLOON AORTIC VALVULOPLASTY
REFUSALS
“MEDICAL THERAPY”
“ASYMPTOMATIC”
The Future: Best CaseThe Future: Best Case
HIGH-RISKPATIENTS
TCAVR
SummarySummary
•• Feasibility demonstrated in Europe, Feasibility demonstrated in Europe, Canada & USCanada & US
•• Transitioning to next phase trials in 2007Transitioning to next phase trials in 2007•• Technology & procedure will expand the Technology & procedure will expand the
market for valve surgerymarket for valve surgeryHigh risk patients not treated today High risk patients not treated today –– safer safer procedureprocedure““ValveValve--inin--valvevalve”” should accelerate tissue should accelerate tissue usage in younger patientsusage in younger patients
42
Transcatheter Aortic Technologies Transcatheter Aortic Technologies
Larry L. WoodVice President and General Manager,
Transcatheter Replacement
Larry L. WoodVice President and General Manager,
Transcatheter Replacement
Transcatheter Aortic Program UpdateTranscatheter Aortic Program Update
Target patient population Market potentialTechnology advancementsRegulatory pathway
43
Aortic Stenosis is Under-treatedAortic Stenosis is Under-treated
There are a number of reasons for the under-treatment:
Patients are too ill for traditional surgeryPatients are judged to be asymptomatic and thus not indicated for surgeryPatients decline surgery due to the invasiveness of the procedure
Less invasive therapies will increase diagnosis and referrals for treatment
Represents symptomatic patients diagnosed with severe ASDoes not include undiagnosed or asymptomatic patients with severe AS
About 50% of Severe Aortic Stenosis Patients Get SurgeryAbout 50% of Severe Aortic Stenosis Patients Get Surgery
* Other includes those with financial concerns, don’t want to live longer, etc.Source: Internal analysis
Annual Flow of Symptomatic, Severe Aortic Stenosis Patients
High operative risk, prohibitive comorbidities
Surgery No Surgery
Patient refusalAgeNot offered
60K
Aortic Replacement
25K
15K
10K
Other*
44
Edwards is Uniquely Positioned to Drive Transcatheter and Surgical ProceduresEdwards is Uniquely Positioned to Drive Transcatheter and Surgical Procedures
There is an abundance of patients with severe aortic stenosis who go untreatedA less invasive technology will lead to increased diagnosis and treatment This would increase both the transcatheter and surgical procedures
Source: AHA, Internal analysis* Only includes therapeutic interventions (not diagnostic angiograms)
Predicted CABG volume based on historical growth Actual CABG volume PCI volume*
PCI introduced
Stentsintroduced
0
100
200
300
‘81 ‘82 ‘83 ‘84 ‘85 ‘86 ‘87 ‘88 ‘89 ‘90 ‘91 ‘92 ‘93 ‘94 ‘95 ‘96 ‘97 ‘98
Thousands
400
500
600
Interventional Procedures Expand the Surgical MarketInterventional Procedures Expand the Surgical Market
45
Total Procedures Doubled by Year FourTotal Procedures Doubled by Year Four
Cardiac Procedures(in thousands)
CABG
“Pre-PCI growth”
0
500
1000PCI
‘81 ‘86 ‘91 ‘96 ‘01
Reimbursement Expected to be Favorable Reimbursement Expected to be Favorable
In the U.S., we have a reimbursement code and sites are being reimbursed for cases performed in the trialWe have country-specific plans in Europe We expect to have reimbursement in place for key markets at time of launchExpect pricing to be in the $13-$17K range global basis
46
Procedural Success Drives Therapy AdoptionProcedural Success Drives Therapy Adoption
4-815-20Number of sites added per month
5-77-9Procedures per month
<250>500Number of sites
Low (85%)High (95%)Variable
Procedural Success
While there are many modeling variables, procedural success is the most important.
Next Generation Edwards – SAPIEN THVNext Generation Edwards – SAPIEN THV
Edwards-SAPIEN THVPrevious
Skirt Height
New Skirt Height
Untreated EquineTissue
[]
Bovine TissueThermaFix TreatmentPericardial MappingLeaflet DeflectionProprietary Processing
Cribier-Edwards PHV
47
Next Generation Valve Leverages Edwards’ Proprietary TechnologyNext Generation Valve Leverages Edwards’ Proprietary Technology
PeriMap Technology Leaflets are optimally matched by thickness
Deflection TestLeaflets are matched for elasticity = improvedcoaptation, performance
One Transcatheter Valve – Two ApproachesOne Transcatheter Valve – Two Approaches
Edwards-SAPIEN THV
Transapical approachusing the
Ascendra Delivery System
Transfemoral approachusing the
RetroFlex Delivery System
48
Two Procedures = More Options for PatientsTwo Procedures = More Options for Patients
By having both procedures available, patients can receive optimal therapyTransapical approach provides surgeons with an advanced technology for treating their high-risk patientsTransfemoral approach provides interventional cardiologists with a technology for treating high-risk patients
Procedural Success ImprovementsProcedural Success Improvements
Our procedural success has been driven by many factors:
Better technologyImproved trainingBetter patient screening
While the improvements have been significant, there is still room for improvement
49
Advanced Training Reduces Learning CurveAdvanced Training Reduces Learning Curve
8%
28%
82 yrs.
Vancouver Transfemoral
Pts. 26-50
16%
28%
82 yrs.
Vancouver Transfemoral
Pts 1-25
7.4%30-day actual mortality
33%30-day predicted mortality
82 yrs.Average age
REVIVALN=54
More than 100 patients Significantly lower 30-day mortality versus predicted in target populationLearning curve improved with advanced training
Future DevelopmentsFuture Developments
Procedural outcomes will improve with better technology State-of-the-art simulation training will accelerate learning and adoptionExpanded indications for use, such as pulmonic valve replacementNext generation valve designs are progressing
50
A Procedural Simulator is Being Usedfor TrainingA Procedural Simulator is Being Usedfor Training
Real patient images
Clinical scenarios
Responsive hemodynamics
Adverse event scenarios
Performance metrics
The Edwards-SAPIEN THV is a Platform TechnologyThe Edwards-SAPIEN THV is a Platform Technology
The Edwards-SAPIEN valve platform can be used to treat pulmonicvalvesWhile this is a relatively small market opportunity compared to aortic, it leverages our existing technology and requires only a modest investment
51
Regulatory UpdateRegulatory Update
Expect to add our next generation delivery systems early next yearOn track in Europe for a late 2007 CE Mark approvalExpect to begin the U.S. pivotal trial in early 2007
Transcatheter Aortic Program SummaryTranscatheter Aortic Program Summary
There is a large unmet clinical need that can be addressed by transcatheter valve technologyEdwards’ transcatheter valve technologies are complementary to our surgical heart valve business Clinical feasibility has been demonstrated and we are ready to move to a pivotal trial Edwards is the clear leader and uniquely positioned to drive this technology
52
Helping Patients is Our LifeHelping Patients is Our Life’’s Work, ands Work, and
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