1

Early Design ConceptsEarly Design Concepts

2

CoreValve DesignCoreValve Design

Inflow Portion

(with skirt)

Constrained Portion

(with valve leaflets)

Outflow Portion

1. Intra-annular anchoring

2. Conforms to native annulus

3. Minimizes paravalvular aortic regurgitation

1. Supra-annular leaflet function

2. Designed to avoid coronaries

1. Sits in ascending aorta

2. Provides PAV alignment

High Hoop Strength

Low Radial Force

High Radial Force

• Frame: Self-expanding laser-cut NitinolFrame: Self-expanding laser-cut Nitinol• Bioprosthesis: Single layer of porcine pericardium sutured Bioprosthesis: Single layer of porcine pericardium sutured

to the frame in a tri-leaflet configurationto the frame in a tri-leaflet configuration

3

Valve and Tissue Optimization to Valve and Tissue Optimization to Reduce StressReduce Stress

Leaflet GeometryLeaflet Geometry

17 mm

Deep cut to lengthen free margin

Extra height increases coaptive surface area

Valve designs that reduce leaflet stresses “are likely Valve designs that reduce leaflet stresses “are likely to have improved performance in long-term to have improved performance in long-term

applications”applications”22

Length of commissures

reduces stress

4

Supra annular location enables CoreValve Supra annular location enables CoreValve to maintain coaptation in elliptical to maintain coaptation in elliptical deploymentdeployment

• CoreValve commissure section minimizes redundancy and CoreValve commissure section minimizes redundancy and excess bending of the leaflets by mitigating inflow ellipticity excess bending of the leaflets by mitigating inflow ellipticity 11

1 Medtronic, data on file.

5

Minimizing Valve Ellipticity Helps Minimizing Valve Ellipticity Helps Maintain Proper Leaflet CoaptationMaintain Proper Leaflet Coaptation

• Minimizing valve ellipticity minimizes leaflet Minimizing valve ellipticity minimizes leaflet prolapsing, buckling, and pinwheeling frequently prolapsing, buckling, and pinwheeling frequently observed in elliptical valve deploymentsobserved in elliptical valve deployments11

Circular DeploymentCircular Deployment Elliptical Deployment Elliptical Deployment (22mm x 30 mm) (22mm x 30 mm)

1. Data on file at Medtronic

6

Near Term DevelopmentsNear Term Developments

7

Enable Multiple Access RoutesEnable Multiple Access Routes

TransFemoral

SubClavian

TransApical

TransAorticMITRAL VALVE

PULMONARYVALVE

AORTIC VALVE(by approach)

8

Delivery Profiles

24 FR 22 FR 20 FR 18 FR 16 FR

CoreValve

Further Decreasing Delivery Profile

9

Continued Future Advances

CoreValve Resheath

Shaft Flare

Recapture and Repositioning

Anti-Mineralization Treatment

10

Delivery System Enhancements Delivery System Enhancements

Simplify Valve Loading

Sheath & catheter length modification depending on procedure approach

Ergonomic Handle Design

11

Next Generation TAVINext Generation TAVI

High Risk & Inoperable

Patient Segments Moderate Risk sAVR

Failed Bioprosthesis

Design Targets

Advanced 10yr+ Durability

AR/PVL < 1+

Reduced Heart Block < 10%

Ease of Use

16Fr Profile

Fully Repositionable

24 Fr 22 Fr 18 Fr 16 Fr

Bicuspid Patients

12

Engager™ Technology: Engager™ Technology: Transapical TAVI SolutionTransapical TAVI Solution

Scalloped bovine pericardial leaflets

Dedicated commissure posts

Arms positioned over native leaflets

Self-expanding nitinol frame

Polyester skirt

• Developed from the Developed from the Ventor acquisitionVentor acquisition

• Feasibility study in fall 2009Feasibility study in fall 2009

• CE mark pivotal trial to CE mark pivotal trial to start soonstart soon

• Developed from the Developed from the Ventor acquisitionVentor acquisition

• Feasibility study in fall 2009Feasibility study in fall 2009

• CE mark pivotal trial to CE mark pivotal trial to start soonstart soon

• True over the wire delivery system providing Flexibility for Better Co-axial Positioning

• Integrated deviceremoving the need for separate introducer

• Partially repositionable/ recapturable system prior to commissure deployment

13

Imaging AdvancementsImaging Advancements

14

Education ImperativeEducation Imperative

15

Vascular Vascular ComplicationsComplicationsVascular Vascular ComplicationsComplications

StrokeStrokeStrokeStroke

Cardiac Cardiac TamponadeTamponadeCardiac Cardiac TamponadeTamponade

Aortic Aortic RegurgitationRegurgitationAortic Aortic RegurgitationRegurgitation

TAVI Product Solutions

Education & Procedural

ImprovementsAncillary

Tools

SheathsAccess Ports

Closure

EmbolicProtection

WiresCatheters

Balloons

Improved Outcomes through WholeImproved Outcomes through WholeProcedure ApproachProcedure Approach

16

Advance Procedural OutcomesAdvance Procedural OutcomesImproving procedure Skin to SkinImproving procedure Skin to Skin

Reduce Embolic Events

Prepare Landing Zone; Reduce PVL

Reduce Vascular Complications

Imaging to Aid Valve Positioning

and Sizing

Reduce Perforations

Percutaneous Pacing

17

Pulmonic Valve Pulmonic Valve Expanding possibilities for Congenital PatientsExpanding possibilities for Congenital Patients

PARVPulmonary Valve for

Native Right Ventricular Outflow Tract (RVOT)

Pulmonary Valve for Native Right Ventricular Outflow Tract (RVOT)