Medtronic Engager Transcatheter Aortic Valve Implantation System Axel

Medtronic Engager™ Transcatheter Aortic Valve Implantation System

Axel Linke, MD Affiliation/Financial Relationship Company • • Grant/Research Support Consulting Fees/Honoraria • • Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Financial Benefit • • • Medtronic Inc. , Claret Medical Inc. Medtronic Inc. , S. Jude Medical Inc. , Claret Medical Inc. , Boston Scientific, Edwards Lifesciences none none

Engager™ Transapical Aortic Valve Implantation System Transapical Delivery System Engager Aortic Bioprosthesis Crimper

Valve Design Bovine Tissue and Crimped Profile Designed for Long-Term Durability Bovine pericardial tissue, supraannular position Control arms Self-expanding nitinol frame with polyester skirt Annulus range: 21 -26. 7 mm Valve sizes: 23 mm & 26 mm

Engager™ Transapical Delivery System • Ergonomic handle with simple three step deployment • Over-the-Wire flexible system • 29 Fr equivalent integrated sheath* Handle Detail: Numbered Steps (1 -3) and Directional Arrows Facilitate Deployment Handle *Delivery system outer diameter: 10. 6 mm

Simple, Stable, Repeatable Delivery Reduced Procedural Complications Valve Embolization Tactile control during deployment allows for precise positioning Paravalvular Leak Coronary Occlusion Seals annulus by Fixation of native capturing the native leaflets and commissure-toconforming to the commissure alignment anatomy for coronary clearance Annular Rupture Self-expanding frame conforms to varying annular shapes

Engager CE Pivotal | Study Overview Primary Endpoint: All-cause mortality at 30 days 100% of all subjects monitored Assessment by an independent echocardiography core lab All serious adverse events adjudicated by independent Clinical Events Committee • Clinical and safety endpoints reported according to Valve Academia Research Consortium (VARC I) definition • •

Engager CE Pivotal | Study Design

Engager CE Pivotal | Baseline

Engager CE Pivotal | Procedural Outcomes

Percent of Patients Engager CE Pivotal | Functional Outcomes

Engager CE Pivotal | 30 -Day Outcomes (N=125) *Calculated for all implanted patients (n=124)

Percent of Patients Engager CE Pivotal | Paravalvular Regurgitation • • Core lab echos were reviewed for N=80 patients 8/80 (10%) were unable to be assessed.

Engager CE Pivotal | Valve Performance

Engager CE Pivotal | Pacemaker Implantation

GARY Registry: Mortality in Transapical TAVI At one year, Engager showed the lowest mortality in TA devices, 14. 7%*

Engager CE Pivotal | Conclusions • The Engager bioprosthesis can be implanted with a high degree of technical success by multiple operators and with an acceptable incidence of serious procedural complications • The system restores effective aortic valve hemodynamic performance: it relieves aortic valve stenosis without inducing significant regurgitation • The Engager TAVI system performs as intended with an acceptable risk/benefit ratio for patients with symptomatic, severe aortic stenosis who are at high or extreme risk for surgical aortic valve replacement.