EVOLUT R, Next Generation, and Future

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Presentation transcript:

EVOLUT R, Next Generation, and Future Rhonda Robb Medtronic, plc

Disclosure: Rhonda Robb is an employee of Medtronic, plc

Self Expanding Program Milestones 10 years since first commercial approval (CE mark) Launched in more than 80 countries >160,000 patients treated >12,000 patients enrolled in MDT sponsored clinical trials (does not include country sponsored registries) 40+ publications in peer reviewed journals SURTAVI Intermediate Risk enrollment complete LBCT Presentation at ACC 3/17 Low Risk Global Trial enrolling

Program Milestones ENCOURAGING RESULTS TO 3 YEARS, FOLLOWING TO 10 YEARS

Program Milestones TVT DATA MATCHES US PIVOTAL DATA

Program Milestones IMPROVED OUTCOMES WITH EVOLUT R

Medtronic Transcatheter Valve Design Evolut r builds on the proven foundation of the corevalve platform CoreValve™ Evolut™ R Evolut™ R Design Goals Low Delivery Profile Unsurpassed Hemodynamics Improved Annular Sealing with Frame Conformability Consistent Radial Force Optimized Oversizing Extended Skirt Supra-Annular Valve Porcine Pericardial Tissue Cell Size Enables Coronary Access Self-Expanding Frame Pericardial Skirt

Patient Annulus Diameter (mm) EVOLUT R ABILITY TO TREAT BROADEST ANNULUS RANGE 18 19 20 21 22 23 24 25 26 27 28 29 30 Patient Annulus Diameter (mm)

EnVeo R Delivery Catheter System Control during deployment ability to recapture and reposition the valve Lowest TRUE Profile 14Fr/16Fr-equivalent Vessel Access ≥ 5.0 mm (23, 26, 29 TAV) ≥ 5.5 mm (34 TAV) Accurate Positioning 1:1 response provides immediate feedback between deployment knob and movement of the capsule Recapture and Reposition Provides option to recapture and reposition for accurate placement

Exceptional Hemodynamics Supra-annular valve design maximizes orifice area

Eliminates Open Spaces Between Struts Evolut PRO Enhanced sealing with proven platform performance Evolut™ R Evolut™ PRO Pericardial Wrap Increases Surface Contact Area 8X for Acute Performance and Enhanced Healing Supra-Annular Valve Porcine Pericardial Tissue Cell Size Enables Coronary Access Self-Expanding Frame Pericardial Skirt Skirt Height 13 mm Eliminates Open Spaces Between Struts Sealing can occur at multiple levels; including above and below calcification with a self-expanding frame Investigational device and not approved for sale

EnVeo PRO SEAMLESS tracking Especially in Tortuous Anatomies Next Generation delivery system SEAMLESS tracking Especially in Tortuous Anatomies FLEXIBLE CAPSULE Investigational device and not approved for sale

Future Medtronic TAVR Programs Continuously building upon a proven, superior platform Evolut NG Horizon Steerable Novel concentric deployment Ultra low profile Complete Control Shorter frame Visualization Superior Hemodynamics Complete Sealing Investigational device and not approved for sale

Self Expanding is a Platform for Expansion Developing novel valves for specific disease states with patient anatomical and clinical needs in mind AORTIC PULMONIC MITRAL Investigational devices and not approved for sale

Conclusions Clear evidence of patient benefit in Extreme/High Risk Patients Program advancements have further improved outcomes New patient populations are under study Continued self expanding platform innovations in TAVI and novel designs for congenital and mitral

Thank You We Truly Appreciate the Collaboration to Advance the Field