1. Engager™ Transapical System Device Overview and Preparation August 2013 Innovating for life. UC201301198a EE

2. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. Objectives Introduction to the Engager ™ device Detailed device preparation steps Outline of the most important aspects from IFU Clarification of why these steps are critical Preparation for bioprosthesis loading certification

3. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. Device Description/Terminology Detail A Introducer Tube Handle Bioprosthesis Retainer Sleeve Control Arm Sleeve Distal Tip Detail A: Bioprosthesis loaded in Delivery System

4. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. Functional Packaging Tray Saline Bath Well for Valve Loading

5. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 1: Identify and Verify Verify delivery system and bioprosthesis are the correct size for the patient on outside packaging Verify functionality of both delivery system stopcocks Wear appropriately sized gloves at all times – loose gloves can snag on the nitinol and tear, gloves that are too tight can puncture/rip easily This can be done by reviewing bioprosthesis and delivery system labeling but the delivery system size is also included on the introducer shaft

6. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 2: Rinse Bioprosthesis Remove bioprosthesis retainer from jar and compare the serial numbers on the blue tag and the jar label. If the serial numbers do not match, do not use the bioprosthesis. Rinse for a total of 6 minutes in 3 separate bowls (2 min./bowl) in 500ml saline Take care when removing bioprosthesis from jar, use sterile forceps and hold the nitinol control arm, confirm the size and the serial number The bioprosthesis should be rinsed for 2 minutes in 3 separate bowls of room temp saline (total of 6 minutes) and should be rinsed/shaken repeatedly. This is similar to CoreValve and removes the residual glutaraldehyde. This can be conducted in conjunction with the initial flushing steps for the delivery system Leave bioprosthesis in sterile saline bath #3 until ready to load onto delivery system

7. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 3: Fill Bath with Chilled Saline, Reposition Device in Tray Fill bath with sterile saline at a temperature between 0-8°C, check level. Wet introducer before moving and position so that tip and tip flushing tube are submerged in saline This should be done gently as bubbles induced from a fast pour make it more difficult to see whether the device is properly flushed. The saline should reach the level of the channel for the introducer (approx 1500ml)

8. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 4: Flush Tip Connect flared end of flushing tube to dilator tip. Use 2 syringes. Move blue knob clockwise. Minimum 2 syringes, 1 syringe while closed, 1 moving forward. Keep flushing if air is seen. Leave in open position The tip section of the Engager ™ delivery system includes a number of places where air can remain if not flushed in accordance with the IFU. As the device diameter is comparatively large this could present a significant clinical problem. Correct flushing of the tip section and device eliminates all air

9. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 4: Flush Tip (cont.) Using one hand on the control arm release (blue) knob and a syringe with flushing tube in the other the flushing can be achieved while advancing the distal tip to the open position. This helps eliminate trapped air in the distal tip/cone section When using any syringe/flushing lumen please eliminate all air prior to use and once the tip is submerged do not bring above saline level until transfer to implanter

10. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 5: Flush Bioprosthesis Retainer Sleeve Using a minimum of 3 syringes while rotating black knob fully clockwise and counter clockwise. Move and flick the bioprosthesis retainer sleeve while keeping the tip submerged. Leave in open position. It will usually take 3 syringes to eliminate all bubbles. The moving/flicking action helps liberate bubbles on the inside of the bioprosthesis retainer sleeve. Again this requires use of both hands. The importance of this step should not be underestimated – any bubbles remaining can adhere to the loaded bioprosthesis frame. With one hand on the black knob and the other on the syringe gradually flush the saline while moving the Bioprosthesis Retainer Sleeve. You may need to flick off some bubbles and to do this the syringe can be left down, while still connected, in the sterile field or on the tray.

11. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 6: Close Stopcock Close bioprosthesis retainer sleeve flushing stopcock Please ensure stopcocks are closed when you are finished with a step – this prevents the saline running back out Once the initial flushing steps are completed the delivery system should be left as outlined above, open and ready to receive the bioprosthesis

12. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 7: Submerge Crimper Place crimper in saline and ensure air bubbles are gone Place crimper over distal end of the delivery system, narrow end first Remove crimper from tray, separate both parts and place the crimper section in the saline bath

13. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 8: Load Bioprosthesis Place commissure points into recesses in bioprosthesis holder Place the bioprosthesis in the holder as shown. Squeezing just below the commissure posts will aid this activity The control arms should be centered behind the tabs

14. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 9: Crimp Bioprosthesis Crimp bioprosthesis onto delivery system by positioning holder with bioprosthesis over delivery system. While it is sitting in crimper, align channels and position so that narrow end is at retainer. Rotate so that bioprosthesis is crimped and eyelets sit in slots in retainer Place the bioprosthesis crimper over the delivery system shaft with the narrow end facing the handle. Place the bioprosthesis and holder as shown. Advance the two parts toward each other, aligning the track and alignment pin

15. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 9: Crimp Bioprosthesis (cont.) Align the proximal end of the crimper with the stainless steel retainer as shown. Align an eyelet on the bioprosthesis with an eyelet on the retainer slot on the retainer Holding the bioprosthesis crimper steady, push the bioprosthesis holder toward crimper while twisting to lock. The result should look as above with an eyelet in each slot. Rotate at this point to ensure all eyelets are correctly located Bioprosthesis holder Bioprosthesis crimper Bioprosthesis retainer

16. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 10: Advance Bioprosthesis Retainer Sleeve Advance bioprosthesis retainer sleeve carefully. Use fingers to walk sleeve over bioprosthesis up to armpits for minimum resistance Advance the bioprosthesis retainer sleeve slowly by rotating the black knob counter clockwise. Keep an eye on the bioprosthesis and when resistance is felt “walk” the sleeve over the bioprosthesis by wiggling the sleeve while advancing the knob. This helps avoid over loading the shafts etc. as continuous turning of the knob against resistance can create significant force

17. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 10: Advance Bioprosthesis Retainer Sleeve (cont.) Once the sleeve reaches the approx. position shown in picture on left remove the crimper by reversing the original motion. The holder section can now be placed on the tray (it is unlikely it will be used again) The crimper section must remain on the shaft until the control arms are crimped. The retainer sleeve can be advanced and manipulated manually now – the frame should be malleable enough to remain deformed due to the chilled saline

18. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 11: Connect Two Syringes Connect 1 full syringe on GW lumen flushing port Connect flared end of dilator tip flushing tube to dilator tip Connect 1 full syringe to flared flushing tube This will eliminate all air from the moving tip section. As there are 3 lumens in this device the full syringe on the GW lumen closes off the “path of least resistance” and allows saline to flow into all sections of the tip

19. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 12: Flush Tip Twice 1 syringe in open position 1 syringe prior to covering commissure posts The tip is now flushed in the open position once (using the flushing tube), the tip is retracted to just before the commissure posts and a second syringe is flushed through

20. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 13: Check Check tissue and posts for bubbles, rotate delivery system and ensure bioprosthesis is in position

21. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 14: Retract Control Arm Sleeve Take care to tuck in tissue while retracting over tissue and posts Retract control arm retainer sleeve over arms Extreme care must be taken around the tissue and commissure posts to prevent the sleeve interacting negatively with them. This is done by very slowly retracting the tip while pressing all 3 leaflets in their entirety toward the center of the delivery system shaft using the thumb, index and middle fingers and rotating and observing the tissue and commissure posts. Also observe and free any air trapped by the tissue Once the commissure post and tissue section is covered the sleeve can be retracted to the closed position. Take care not to pinch a glove between the control arm and capsule

22. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 15: Final Tip Flush 1 syringe with the control arm retainer sleeve about 1mm from the endstop Advance the knob slightly and flush one more time from the distal end. This eliminates any air trapped in the tissue

23. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 16: Check and Close Advance to safety stop and check for bubbles on control arms and sleeve Fully close Advance the control arm sleeve to the safety stop (deploy the control arms) and rotate device to check for air bubbles. Flick off any bubbles present (unlikely if previous steps completed correctly). Reclose the sleeve as outlined before

24. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 17: Pull Vacuum on Introducer Pull device back to release and sit forward Connect syringe with 2 ml of saline Pull vacuum while fully submerged This will allow the introducer to be fully submerged for flushing. Take care not to bring tip over saline level. Fill the syringe with approximately 2 ml of saline and pull a vacuum with the introducer fully submerged (including green hub). The syringe will fill with air first and once emptied the saline level in the syringe will rise. Close the stopcock

25. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 18: Connect the Introducer Ensure introducer tube and control arm sleeve are connected Leave submerged with syringe on guidewire lumen until use Advance the introducer toward the tip and slide carefully over control arms to form a smooth continuous surface. Keep the device submerged until required by the nurse/physician

26. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 19: Transfer Remove syringe immediately after the transfer Communicate to nurse or physician to maintain connection between introducer tube and control arm sleeve To transfer device to nurse, keep the syringe on GW lumen and maintain the device horizontal (to avoid the saline pouring out) then transfer to the nurse. Syringe may be removed after the transfer. Ensure the control arm sleeve and introducer remain sealed together until the device enters the patients apex

27. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. STEP 20: Backload Guidewire Communicate correct method of transfer onto guidewire Hands should be kept together. Try to keep the guidewire lumen aligned through the tip and move cone as needed to aid guidewire insertion Communicate correct GW loading to nurse/physician. The dilator tip and GW lumen both need to be accessed so keeping your hands close together will aid loading

28. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. MRI Compatibility* The Medtronic Engager™ transcatheter aortic bioprosthesis satisfies the acceptance criteria of not posing additional patient risk when subjected to <3 T MRI conditions Nonclinical testing and modeling has demonstrated that the Medtronic Engager™ transcatheter aortic bioprosthesis is MR Conditional. It can be scanned safely under the following conditions: Static magnetic field of <3 T Spatial gradient field of <2500 gauss/cm Normal operating mode only with a maximum whole-body-averaged specific absorption rate (SAR) of 2W/kg for 15 minutes of scanning as read from equipment monitor *Refer to IFU for all details

29. Academia Medical Education INTERNATIONAL. CAUTION: For distribution only in markets where Engager ™ is approved. Medtronic, Inc. 2013. All Rights Reserved. Summary The Engager ™ device is comprised of a three component system: Bovine pericardial bioprosthesis, delivery catheter and crimper The Engager Bioprosthesis is available in two sizes: 23 and 26 mm Bioprosthesis loading is an intensive process that requires attention to detail Engager is a registered trademark of Medtronic, Inc. For more information and a complete list of adverse events, warning and contraindications reference Engager IFU.