Medtronic Engager™

Transcatheter Aortic Valve Implantation System Procedure Quick Review And TipsAugust 2013

Innovating for life.UC201305602a EE

Engager is a registered trademark of Medtronic 3F Therapeutics, Inc.

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INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. All Rights Reserved.

1. Dilator tip 10. Introducer flushing tube2. Moving cone 11. Control arm retainer sleeve flushing

tube3. Control arm retainer sleeve 12. Commissure post release (Green)

button 4. Bioprosthesis retainer with eyelet retention slots

13. Control arm release (Blue) knob

5. Bioprosthesis retainer sleeve 14. Bioprosthesis deployment (Black) knob

6. Outer shaft 15. Handle body7. Bioprosthesis holder 16. Bioprosthesis retainer sleeve

flushing tube8. Bioprosthesis crimper 17. Guidewire lumen9. Transapical introducer tube

System Overview

AcademiaMedical Education

INTERNATIONAL. CAUTION: For distribution only in markets where Engager™ is approved. Medtronic, Inc. 2013. All Rights Reserved.

10-Step Implantation Summary1 - Identify Implanter’s View

2 - Assess & Prepare Implant

1.Implanter’s view aortic root angiogram2.Prepare LV and pigtail access sites3.Test pacing lead4.Place pigtail catheter in NCC5.Place guidewire through LV apex into descending aorta6.If BAV performed, use 4 cm balloon length; Balloon diameter 1 mm ≤ MSCT effective diameter

3 - Advance Delivery System

4 - Ensure Correct Rotational Alignment

5 - Release & Position Control Arms

6 - Release Commissure Posts

7- Deploy Bioprosthesis 8 - Retract & Close Delivery System

9 - Remove Delivery System

10 - Assessment & Closure

1.Pressure measurements by simultaneous recordings of LV and aortic pressures2.Aortic root angiography3.ECG for arrhythmias and/or heart block4.Remove wire using Judkins5.Close apex

Rotate handle to align the bioprosthesis retainer flat edge with the non-coronary sinus.

1. Rotate blue knob CW (reference arrow on knob)

2. Gently retract delivery system

1. Activate green button2. Rotate blue knob CW

Exert slight back pressure against native valve

Rotate black knob CW

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1. Hold introducer in place

2. Retract delivery system until control arm sleeve docks with introducer

3. Use second projection to verify correct position of control arms