Amplatzer Amulet LEFT ATRIAL APPENDAGE OCCLUSION DEVICE AN

Amplatzer™ Amulet™ LEFT ATRIAL APPENDAGE OCCLUSION DEVICE

AN ALTERNATIVE THERAPY FOR REDUCING THE RISK OF STROKE IN PATIENTS WITH ATRIAL FIBRILLATION 1 LEFT ATRIAL APPENDAGE OCCLUSION STEP BY STEP 1. Tzikas, A. , Shakir, S. , Gafoor, S. , Omran, H. , Berti, S. , Santoro, G. , . . . Park, J. W. (2016). Left atrialappendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug. Euro. Intervention, 11(10), 1170 -1179. Information contained herein is for distribution in Europe, Middle East and Africa only. 9 -EH-4 -7491 -01 03 -2018 REV A

Indications The AMPLATZER™ Amulet™ left atrial appendage occluder is a percutaneous transcatheter device intended to prevent thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation 3

AMPLATZER™ Amulet™ Design DISC • Designed to completely seal the LAA at the orifice LOBE • Positioned inside the LAA neck • Designed to conform to different sizes and shapes of LAA anatomy STABILIZING WIRES • Engage with the wall of the LAA • Help hold the device in place WAIST • Maintains tension between lobe and disc • Flexible connection allows device to self-orient Information contained herein is for distribution in Europe, Middle East and Africa only. 9 -EH-4 -7491 -01 03 -2018 REV A 4

AMPLATZER™ Amulet™ Device Specifications Disc diameter FEATURE Size / Lobe Diameter (mm) Disc Diameter AMPLATZER™ AMULET™ DEVICE 16 18 20 22 Lobe +6 mm 25 28 31 34 Lobe length Lobe +7 mm Device size Lobe Length 7. 5 mm 10 mm Waist Length 5. 5 mm 8 mm Stabilizing Wires Sheath Diameter 6 pairs 8 pairs 12 F 14 F (with adaptor) 10 pairs 14 F Information contained herein is for distribution in Europe, Middle East and Africa only. 9 -EH-4 -7491 -01 03 -2018 REV A 5

AMPLATZER™ Amulet™ Pre procedure checklist Standard Procedure Implant and Delivery Sheath • Short sheath • AMPLATZER™ Amulet™ Left Atrial Appendage Occluder (all sizes) • Guidewire(s) • Transseptal sheath and dilator • Transseptal needle • AMPLATZER™ Amulet ™ Delivery System (all sizes) • 5 F marker pigtail • Y connector/hemostasis valve Emergency Kit • Large bowl filled with sterile saline • Large sheaths >16 F • >35 cc luer syringe for flushing device • Snares for device retrieval • Contrast medium • Pericardial puncture and drainage kit Information contained herein is for distribution in Europe, Middle East and Africa only. 9 -EH-4 -7491 -01 03 -2018 REV A 6

AMPLATZER™ Amulet™ TEE initial assessment Check for baseline pericardial effusion Assess the mitral valve Assess for thrombus (if present, device implantation contraindicated) Assess for PFO (patent foramen ovale) Appendage landing zone size (11 -31 mm) Images courtesy of Prof Werner Budts Information contained herein is for distribution in Europe, Middle East and Africa only. 9 -EH-4 -7491 -01 03 -2018 REV A 7

AMPLATZER™ Amulet™ Transseptal puncture Inferior posterior puncture site TEE bicaval view (90°) INFERIOR TEE short axis view (45° - 60°) (ACT≥ 250 secs – consider part dose prior to transseptal puncture remainder post puncture¹) SUPERIOR POSTERIOR DOWN UP PULL Heparin ANTERIOR CLOCKWISE 1. Tzikas, A. P. et al. 2016. Left Atrial Appendage Occlusion with the Amplatzer Amulet device: an expert consensus step-by-step approach. Eurointervention. Apr 20; 11(13): 1512 -21. Images courtesy of Dr. David Meerkin and Dr. Apostolos Tzikas Information contained herein is for distribution in Europe, Middle East and Africa only. 9 -EH-4 -7491 -01 03 -2018 REV A 8

AMPLATZER™ Amulet™ Imaging The projection used for measurement should be the same as the procedure imaging TEE Multiple views 0 -135° Angio RAO 30° CRA 10 -20° and RAO 30° CAU 10 -20° c. Landing zone b. Depth and axis of LAA neck a. Orifice of the LAA Device sizes ≤ 22 mm Measure ≥ 10 from ostium Device sizes ≥ 25 mm Measure ≥ 12 from ostium Images courtesy of Prof Werner Budts Information contained herein is for distribution in Europe, Middle East and Africa only. 9 -EH-4 -7491 -01 03 -2018 REV A 9

AMPLATZER™ Amulet™ Imaging & sizing Disc diameter MAXIMUM LANDING ZONE WIDTH (mm) AMULET™ DEVICE SIZE LOBE LENGTH (mm) MINIMUM LAA DEPTH (mm) DISC DIAMETER (mm) 11. 0 - 13. 0 16 7. 5 ≥ 10 22 13. 0 - 15. 0 18 7. 5 ≥ 10 24 15. 0 - 17. 0 20 7. 5 ≥ 10 26 17. 0 - 19. 0 22 7. 5 ≥ 10 28 19. 0 - 22. 0 25 10 ≥ 12 32 22. 0 - 25. 0 28 10 ≥ 12 35 25. 0 - 28. 0 31 10 ≥ 12 38 28. 0 - 31. 0 34 10 ≥ 12 41 SHEATH DIAMETER Lobe length 12 F or 14 F (with adaptor) Device size 14 F Information contained herein is for distribution in Europe, Middle East and Africa only. 9 -EH-4 -7491 -01 03 -2018 REV A 10

AMPLATZER™ Amulet™ Device preparation Connect the hemostasis valve to the loader. Check and tighten all connections. Advance the tip of the Amulet™ device to the tip of the loader. Ensure the device is attached to the delivery cable by rotating the delivery cable/delivery cable vise clockwise until resistance is felt. De-air the hemostasis valve using a 35 -50 cc syringe of sterile saline. Flush a 35 -50 cc syringe of saline through the loader. Repeat. Rapidly pull back on syringe and then forward flush without disconnection of the syringe. Repeat. Information contained herein is for distribution in Europe, Middle East and Africa only. 9 -EH-4 -7491 -01 03 -2018 REV A 11

Sheath & device Access to LAA Proprietary and confidential — do not distribute Information contained herein is for distribution in Europe, Middle East and Africa only. 9 -EH-4 -7491 -01 03 -2018 REV A

AMPLATZER™ Amulet™ Deployment summary Ball Counter-Clockwise Lobe Disc 5 signs Tug test Courtesy of Dr. Tzikas Information contained herein is for distribution in Europe, Middle East and Africa only. 9 -EH-4 -7491 -01 03 -2018 REV A 13

Sheath & Device Stability - CLOSE VERIFICATION OF STABILITY C Cx lobe at least 2/3 distal (IFU)(Discussion point for 25 mm+ devices with a 10 mm lobe 1) L Lobe compression O Orientation of lobe in line with axis of the LAA neck S Separation between the device lobe and disc E Elliptical (concave disc) Before device release, always check the CLOSE signs of proper Amulet™ device deployment If device position is unsatisfactory, recapture the device and redeploy per the IFU *Images courtesy of Dr. Tzikas and Prof Budts Tzikas, A. , Gafoor, S. , Meerkin, D. , Freixa, X. , Cruz-Gonzalez, I. , Lewalter, T. , . . . Omran, H. (2016). Left atrial appendage occlusion with the AMPLATZER Amulet device: an expert consensus step-by-step approach. Euro. Intervention, 11(13), 1512 -1521. Proprietary and confidential — do not distribute Information contained herein is for distribution in Europe, Middle East and Africa only. 9 -EH-4 -7491 -01 03 -2018 REV A 14

AMPLATZER™ Amulet™ Ease of recapture Sheath Marker Brand If device position is unsatisfactory, recapturing and repositioning is possible Platinum Thread on Device 1 2 3 Hold the delivery cable in place Re-advance the sheath until platinum thread markers are aligned with marker band on the sheath and device is in a ball position 4 5 The device can be partially recaptured and redeployed a maximum of 3 times If the device is retracted farther than the radiopaque markers the device and the delivery sheath must both be removed and replaced Do not retract device farther than the platinum markers to avoid damaging the sheath Information contained herein is for distribution in Europe, Middle East and Africa only. 9 -EH-4 -7491 -01 03 -2018 REV A 15

AMPLATZER™ Amulet™ Optional tug test and release Release FINAL ASSESSMENT Rotate the delivery cable and/or the delivery cable vise counter-clockwise up to 8 rotations 1 Hold gentle tension on the device to further assess stability 2 Do not perform a vigorous wiggle test 3 Reassess five signs of proper deployment following gentle pull (optional Tug test) Image courtesy of Prof Budts Information contained herein is for distribution in Europe, Middle East and Africa only. 9 -EH-4 -7491 -01 03 -2018 REV A 16

AMPLATZER™ Amulet™ Post procedure An anticoagulation and/or antiplatelet regimen is recommended to reduce risk of adverse events, including intracardiac thrombus 1 Check TTE 2 Post procedure medication Aspirin (or an alternate antiplatelet) is recommended for patients for 6 months post implant The decision to continue this regimen after 6 months is at the discretion of the physician Clopidogrel (or an alternate antiplatelet) is recommended for patients and prescription should follow routine standard of care Information contained herein is for distribution in Europe, Middle East and Africa only. 9 -EH-4 -7491 -01 03 -2018 REV A 17

AMPLATZER™ Amulet™ Specifications AMPLATZER™ AMULET™ LEFT ATRIAL APPENDAGE OCCLUDER AMPLATZER™ AMULET™ DELIVERY SHEATH AMPLATZER™ GUIDEWIRE Recom’d Sheath Sz Model / Reorder Nº Lobe Diam (mm) Disc Diam (mm) Lobe Lgth (mm) 9 -ACP 2 -007 -016 16 22 7. 5 12 F or 14 F with adaptor 9 -ACP 2 -007 -018 18 24 7. 5 12 F or 14 F with adaptor 9 -ACP 2 -007 -020 20 26 7. 5 12 F or 14 F with adaptor 9 -ACP 2 -007 -022 22 28 7. 5 12 F or 14 F with adaptor 9 -ACP 2 -010 -025 25 32 10 12 F or 14 F with adaptor 9 -ACP 2 -010 -028 28 35 10 14 F 9 -ACP 2 -010 -031 31 38 10 14 F 9 -ACP 2 -010 -034 34 41 10 14 F (French) Model / Reorder Nº Sheath Size Tip Angle Inner Diam of Sheath (mm/in) Outer Diam of Sheath (mm/in) DS-TV 45 X 45 -12 F-080 12 F 45º x 45º 4. 00/0. 16 4. 80/0. 19 80 DS-TV 45 X 45 -14 F-080 14 F 45º x 45º 4. 80/0. 19 5. 50/0. 22 80 Model / Reorder Nº Diam (in) Body Floppy Tip Lgth Tip Description 9 -GW-002 0. 035 Super Stiff 5 Information contained herein is for distribution in Europe, Middle East and Africa only. 9 -EH-4 -7491 -01 03 -2018 REV A (cm) 1. 5 mm, Modified J-tip Usable Length (cm) 260 18

Abbott Vascular International BVBA Park Lane, Culliganlaan 2 B, B-1831 Diegem, Belgium This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. Information contained herein is for distribution in Europe, Middle East and Africa only. All products herein are trademarks of the Abbott Group of Companies. All drawings are artist’s representations only and should not be considered as an engineering drawing or photograph. Photo(s) on file at Abbott. For more information, visit our web site at www. abbott. com © 2018 Abbott. All rights reserved. 9 -EH-4 -7491 -01 03 -2018 REV A 19