Zenith Alpha Thoracic case planning guide

Transcription

1 Zenith Alpha Thoracic case planning guide Zenith Alpha T HORACIC ENDOVASCULAR GRAFT MEDICAL

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3 Zenith Alpha Thoracic case planning guide Zenith Alpha T HORACIC ENDOVASCULAR GRAFT Zenith Alpha Thoracic Endovascular Graft Indications for use... Graft specifications and component ordering information...-1 Deployment overview Accessories for thoracic endovascular graft procedures Component ordering information MEDICAL 2

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5 Zenith Alpha T HORACIC ENDOVASCULAR GRAFT

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7 Zenith Alpha Thoracic Endovascular Graft: indications for use Aneurysm or ulcer Blunt injury proximal neck length 20 mm proximal neck diameter mm distal neck diameter mm distal neck length 20 mm le sse r grea t e r aortic arch radius of curvature 20 mm proximal neck diameter mm proximal neck length 20 mm distal neck diameter mm distal neck length 20 mm Indications for use The Zenith Alpha Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with aneurysms, ulcers, or blunt thoracic aortic injury of the descending thoracic aorta who have vascular morphology suitable for endovascular repair, including: Iliac (femoral) anatomy that is suitable for access with the required introduction systems, Non-aneurysmal aortic segments (fixation sites) proximal and distal to the aneurysms, ulcers, or blunt thoracic aortic injury: with a length of at least 20 mm with a diameter measured outer wall to outer wall of no greater than 42 mm and no less than 15 mm Length Aortic fixation site diameter Angulation/ curvature Access Non-aneurysmal aortic necks proximal and distal to the aneurysms, ulcers, or blunt injuries with a length mm (measured outer wall to outer wall) A radius of curvature 20 mm for aortic arch landing zones An angle 45 degrees (any angle in the arch or distal aorta) Adequate iliac (femoral) access compatible with the required introduction systems Introducer diameters 1 30 mm grafts: ID 16 Fr (5.3 mm) OD 6.0 mm 32 3 mm grafts: ID 1 Fr (6.0 mm) OD.1 mm mm grafts: ID 20 Fr (6. mm) OD. mm Contraindications Patients with known sensitivities or allergies to polyester, polypropylene, nitinol, or gold. Patients with a systemic infection who may be at increased risk of endovascular graft infection. 6

8 Zenith Alpha Thoracic Endovascular Graft: graft specifications Proximal component 1, 20, 22, 24, 26 mm 2, 30, 32 mm 2, 30, 32 mm 2, 30, 32 mm 34, 36 mm 5 mm mm 155 mm 201 mm 3 mm 34, 36 mm 34, 36 mm 3, 40 mm 3, 40 mm 3, 40 mm 161 mm 20 mm mm 16 mm 21 mm Note: Red numbers between stents indicate fabric gap lengths in millimeters (mm). Fabric gaps may vary. Introduction system for proximal component 1-30 mm grafts: 16 Fr (5.3 mm) ID/6.0 mm OD 32-3 mm grafts: 1 Fr (6.0 mm) ID/.1 mm OD mm grafts: 20 Fr (6. mm) ID/. mm OD cm 5 cm

9 Zenith Alpha Thoracic Endovascular Graft: component ordering information Diameter Order Number Reference Part Number Diameter mm Proximal Component Length mm Introducer Sheath ID/OD Fr (mm)/mm Proximal component length Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. 1 mm Diameter G3532 ZTA-P-1-5-W (5.3)/ mm Diameter G3532 ZTA-P-20-5-W (5.3)/ mm Diameter G35331 ZTA-P-22-5-W (5.3)/ mm Diameter G35333 ZTA-P-24-5-W (5.3)/ mm Diameter G35335 ZTA-P-26-5-W (5.3)/6.0 2 mm Diameter G3533 ZTA-P-2--W 2 16 (5.3)/6.0 G3533 ZTA-P W (5.3)/6.0 G35340 ZTA-P W (5.3)/ mm Diameter G35341 ZTA-P-30--W (5.3)/6.0 G35343 ZTA-P W (5.3)/6.0 G35344 ZTA-P W (5.3)/ mm Diameter G35345 ZTA-P-32--W 32 1 (6.0)/.1 G3534 ZTA-P W (6.0)/.1 G3534 ZTA-P W (6.0)/.1 34 mm Diameter G3534 ZTA-P-34-3-W (6.0)/.1 G35351 ZTA-P W (6.0)/.1 G35352 ZTA-P W (6.0)/.1 36 mm Diameter G35353 ZTA-P-36-3-W (6.0)/.1 G35355 ZTA-P W (6.0)/.1 G35356 ZTA-P W (6.0)/.1 3 mm Diameter G3535 ZTA-P-3--W 3 1 (6.0)/.1 G3535 ZTA-P-3-16-W (6.0)/.1 G35360 ZTA-P-3-21-W (6.0)/.1 40 mm Diameter G35361 ZTA-P-40--W (6.)/. G35363 ZTA-P W (6.)/. G35364 ZTA-P W (6.)/. 42 mm Diameter G35365 ZTA-P-42-1-W (6.)/. G3536 ZTA-P W (6.)/. G3536 ZTA-P W (6.)/. 44 mm Diameter G3536 ZTA-P-44-5-W (6.)/. G3531 ZTA-P-44-1-W (6.)/. G3532 ZTA-P W (6.)/.

10 Zenith Alpha Thoracic Endovascular Graft: graft specifications Proximal component 42 mm 42 mm 42 mm 44, 46 mm 44, 46 mm 1 mm 13 mm 225 mm 5 mm 1 mm 44, 46 mm 233 mm Note: Red numbers between stents indicate fabric gap lengths in millimeters (mm). Fabric gaps may vary. Introduction system for proximal component 1-30 mm grafts: 16 Fr (5.3 mm) ID/6.0 mm OD 32-3 mm grafts: 1 Fr (6.0 mm) ID/.1 mm OD mm grafts: 20 Fr (6. mm) ID/. mm OD cm 5 cm

11 Zenith Alpha Thoracic Endovascular Graft: component ordering information Diameter Proximal component Component ordering information continued from page Order Number 46 mm Diameter Reference Part Number Diameter mm Proximal Component Length mm Introducer Sheath ID/OD Fr (mm)/mm G3533 ZTA-P-46-5-W (6.)/. G3535 ZTA-P-46-1-W (6.)/. G3536 ZTA-P W (6.)/. Proximal component length Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details.

12 Zenith Alpha Thoracic Endovascular Graft: graft specifications Proximal tapered component 26 mm 30 mm 32 mm 32 mm 34 mm 5 mm mm 1 mm 201 mm 161 mm 22 mm 26 mm 30 mm 2 mm 2 mm 34 mm 36 mm 36 mm 3 mm 3 mm 20 mm 161 mm 20 mm 16 mm 21 mm 32 mm 34 mm 34 mm 30 mm 32 mm Note: Red numbers between stents indicate fabric gap lengths in millimeters (mm). Fabric gaps may vary. Introduction system for proximal tapered component mm grafts: 16 Fr (5.3 mm) ID/6.0 mm OD 32-3 mm grafts: 1 Fr (6.0 mm) ID/.1 mm OD mm grafts: 20 Fr (6. mm) ID/. mm OD cm 5 cm

13 Zenith Alpha Thoracic Endovascular Graft: component ordering information Proximal diameter Order Number Reference Part Number Proximal- Distal Diameter mm Proximal Tapered Component Length mm Introducer Sheath ID/OD Fr (mm)/mm Proximal tapered component length 26 mm Diameter G3055 ZTA-PT W (5.3)/ mm Diameter G302 ZTA-PT W (5.3)/ mm Diameter G305 ZTA-PT W (6.0)/.1 G311 ZTA-PT W (6.0)/.1 34 mm Diameter G312 ZTA-PT W (6.0)/.1 G313 ZTA-PT W (6.0)/.1 36 mm Diameter G31 ZTA-PT W (6.0)/.1 G31 ZTA-PT W (6.0)/.1 3 mm Diameter G310 ZTA-PT W (6.0)/.1 G3 ZTA-PT W (6.0)/.1 Distal diameter Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details.

14 Zenith Alpha Thoracic Endovascular Graft: graft specifications Proximal tapered component 40 mm 40 mm 42 mm 42 mm 44 mm 16 mm 21 mm 13 mm 225 mm 1 mm 36 mm 3 mm 40 mm 36 mm 3 mm 44 mm 46 mm 46 mm 233 mm 1 mm 233 mm 42 mm 40 mm 42 mm Note: Red numbers between stents indicate fabric gap lengths in millimeters (mm). Fabric gaps may vary. Introduction system for proximal tapered component mm grafts: 16 Fr (5.3 mm) ID/6.0 mm OD 32-3 mm grafts: 1 Fr (6.0 mm) ID/.1 mm OD mm grafts: 20 Fr (6. mm) ID/. mm OD cm 5 cm 13

15 Zenith Alpha Thoracic Endovascular Graft: component ordering information Proximal diameter Proximal tapered component Component ordering information continued from page Order Number Reference Part Number Proximal- Distal Diameter mm Proximal Tapered Component Length mm Introducer Sheath ID/OD Fr (mm)/mm Proximal tapered component length 40 mm Diameter G3 ZTA-PT W (6.)/. G3201 ZTA-PT W (6.)/. 42 mm Diameter G3203 ZTA-PT W (6.)/. G3204 ZTA-PT W (6.)/. 44 mm Diameter G320 ZTA-PT W (6.)/. G3216 ZTA-PT W (6.)/. 46 mm Diameter G3220 ZTA-PT W (6.)/. G3236 ZTA-PT W (6.)/. Distal diameter Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. 14

16 Zenith Alpha Thoracic Endovascular Graft: graft specifications Distal component 2, 30, 32 mm 34, 36 mm 34, 36 mm 3 mm 3, 40 mm 160 mm 142 mm mm 14 mm 1 mm 42 mm 44, 46 mm 204 mm 2 mm Note: Red numbers between stents indicate fabric gap lengths in millimeters (mm). Fabric gaps may vary. Introduction system for distal component 2-30 mm grafts: 16 Fr (5.3 mm) ID/6.0 mm OD 32-3 mm grafts: 1 Fr (6.0 mm) ID/.1 mm OD mm grafts: 20 Fr (6. mm) ID/. mm OD cm 5 cm 15

17 Zenith Alpha Thoracic Endovascular Graft: component ordering information Diameter Order Number Reference Part Number Diameter mm Distal Component Length mm Introducer Sheath ID/OD Fr (mm)/mm Distal component length 2 mm Diameter G3531 ZTA-D W (5.3)/ mm Diameter G3533 ZTA-D W (5.3)/ mm Diameter G3535 ZTA-D W (6.0)/.1 34 mm Diameter G3531 ZTA-D W (6.0)/.1 G3532 ZTA-D-34--W 34 1 (6.0)/.1 36 mm Diameter G3533 ZTA-D W (6.0)/.1 G3534 ZTA-D-36--W 36 1 (6.0)/.1 3 mm Diameter G3535 ZTA-D-3-14-W (6.0)/.1 G3536 ZTA-D-3-1-W (6.0)/.1 40 mm Diameter G353 ZTA-D-40-1-W (6.)/. 42 mm Diameter G35400 ZTA-D W (6.)/. 44 mm Diameter G35402 ZTA-D-44-2-W (6.)/. 46 mm Diameter G35404 ZTA-D-46-2-W (6.)/. Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. 16

18 Zenith Alpha Thoracic Endovascular Graft: graft specifications Distal extensions 22, 26 mm 30 mm 34, mm 4 mm mm 1 mm 3 mm 42 mm 46 mm 1 mm 4 mm mm Note: Red numbers between stents indicate fabric gap lengths in millimeters (mm). Fabric gaps may vary. Introduction system for distal extension mm grafts: 16 Fr (5.3 mm) ID/6.0 mm OD 34-3 mm grafts: 1 Fr (6.0 mm) ID/.1 mm OD mm grafts: 20 Fr (6. mm) ID/. mm OD cm 5 cm 1

19 Zenith Alpha Thoracic Endovascular Graft: component ordering information Diameter Order Number Reference Part Number Diameter mm Distal Extension Length mm Introducer Sheath ID/OD Fr (mm)/mm Distal extension length 22 mm Diameter G35506 ZTA-DE-22-4-W (5.3)/ mm Diameter G355 ZTA-DE-26-4-W (5.3)/ mm Diameter G35515 ZTA-DE-30--W (5.3)/ mm Diameter G3551 ZTA-DE-34-1-W (6.0)/.1 3 mm Diameter G35523 ZTA-DE-3-1-W (6.0)/.1 42 mm Diameter G36346 ZTA-DE-42-4-W (6.)/. 46 mm Diameter G302 ZTA-DE-46--W (6.)/. Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. 1

20 Zenith Zenith LP AAA Alpha - Graft Thoracic Specifications Endovascular Graft: deployment overview Deployment overview* 1 POSITION A LUNDERQUIST EXTRA-STIFF DC WIRE GUIDE IN THE AORTIC ARCH Through the pigtail flush catheter, replace the standard guide wire with an extra-stiff,.035, 260 or 300 cm double-curved Lunderquist wire guide up to the level of the aortic arch and remove the pigtail. 2 POSITION THE PROXIMAL COMPONENT Introduce the introduction system for the proximal component over the extra-stiff doublecurved Lunderquist wire guide and advance until you reach the desired graft position. Caution: To avoid twisting the graft, never rotate the introduction system during the procedure. Allow the device to conform naturally. Do not advance the sheath while the graft is still inside the sheath. Doing so may cause the barbs to perforate the introducer sheath. 3 UNSHEATHE THE PROXIMAL COMPONENT While you constantly monitor the graft position, withdraw the sheath until the graft is fully expanded and the valve assembly with the Captor sleeve docks with the black gripper. 4 RELEASE THE PROXIMAL COMPONENT Hold the black gripper and loosen the black safety-lock knob on the blue rotating handle (turn in the direction of the arrows). Turn the blue rotating handle following the directional arrow next to label 1 until a stop is felt. The stop indicates that the uncovered stent and proximal end of the graft have opened and the distal attachment to the introducer has been released. 5 REMOVE THE INTRODUCER SYSTEM FOR THE PROXIMAL COMPONENT Remove the introduction system entirely, leaving the wire guide positioned in the graft. * This deployment overview is an outline highlighting the deployment process for the Zenith Alpha Thoracic Endovascular Graft. The suggested Instructions for Use booklet should be consulted for a more thorough examination of the deployment protocol, indications, contradications, warnings and precautions. 1

21 Zenith Alpha Thoracic Endovascular Graft: deployment overview Deployment overview (continued)* 6 POSITION THE DISTAL COMPONENT Introduce the hydrated introduction system until the desired graft position has been achieved. Ensure that there is a minimum overlap of 3 stents. UNSHEATHE THE DISTAL COMPONENT Stabilize the gray positioner and withdraw the sheath until the Captor sleeve docks with the telescoping black gripper. 1. OVERLAP RELEASE THE DISTAL COMPONENT Use the deployment sequence. 1. To release the distal attachment, hold the black gripper and loosen the black safety-lock knob on the blue rotating handle (turn the safety-lock knob in the direction of the arrows). Turn the blue rotating handle following the directional arrow next to label 1 until a stop is felt. 2. Turn the gray safety-lock knob indicated by label 2 on the black gripper (turn the safety-lock knob in the direction of the arrows). To release the distal bare stent, stabilize the introduction system and slide the black gripper over the gray tube and outer sheath in a distal direction until it locks automatically into position next to the blue rotating handle (the release window on the blue rotating handle next to label 3 will turn green). 3. Turn the blue rotating handle in the direction of the arrow (label 3) until a stop is felt and the proximal end of the graft opens. OPTIONAL: MOLDING BALLOON Advance the molding balloon over the wire guide and through the hemostatic valve of the main body introduction system to the level of the proximal fixation seal site. Maintain proper sheath positioning. Tighten the Captor Hemostatic Valve around the molding balloon by turning it clockwise with gentle pressure. Caution: Do not inflate the balloon in the vessel outside of the graft. Expand the molding balloon with diluted contrast media (as directed by the manufacturer) in the area of the proximal covered stent, starting proximally and working in the distal direction. * This deployment overview is an outline highlighting the deployment process for the Zenith Alpha Thoracic Endovascular Graft. The suggested Instructions for Use booklet should be consulted for a more thorough examination of the deployment protocol, indications, contradications, warnings and precautions. 20

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23 Accessories for thoracic endovascular graft procedures: component ordering information We have the accessories you need for your thoracic EVAR cases, from access needles and catheters to dilators, introducers, and wire guides. Order Number Reference Part Number Description Quantity Access Needle G046 SDN-1UT-.0 Percutaneous Entry Ultra-Thinwall Needle 1 Balloons G233 CODA Coda Balloon Catheter 1 Catheters G6 SCBR P-NS-DAV Slip-Cath Beacon Tip Hydrophilic Angiographic Catheter 1 G2535 SCBR P-NS-KMP Slip-Cath Beacon Tip Hydrophilic Angiographic Catheter 1 G00 SCBR P-NS-VERT Slip-Cath Beacon Tip Hydrophilic Angiographic Catheter 1 G002 SCBR P-NS-MPA Slip-Cath Beacon Tip Hydrophilic Angiographic Catheter 1 G316 NR P-S-PIG-CSC-20 Beacon Tip Aurous Centimeter Vessel Sizing Catheter 5 Dilator Sets G5233 JCDS-14-EDS-HC Endovascular Dilator Set 1 G5234 JCDS-161-EDS-HC Endovascular Dilator Set 2 G5235 JCDS-2022-EDS-HC Endovascular Dilator Set 2 G5236 JCDS-2426-EDS-HC Endovascular Dilator Set 2 Introducer Only G0431 RCFW-.0-3 Performer Introducer 1 G245 RCFW Performer Introducer 1 Introducer Only Radiopaque Band G0 RCFW RB Performer Introducer 1 G032 RCFW RB Performer Introducer 1 Introducer Set with J-Wire G03 RCF J Performer Introducer 1 G040 RCF-.0-3-J Performer Introducer 1 Wire Guides G01431 TSFB BH Bentson Straight Heparin Coated Fixed Core Wire Guide 1 G4520 TSCMG LESDC Lunderquist Extra-Stiff Double Curved Exchange Support Wire Guide 5 G4540 TSCMG LESDC Lunderquist Extra-Stiff Double Curved Exchange Support Wire Guide 5 G536 TSCMG E-LESDC Lunderquist Extra-Stiff Extended Double Curved Exchange Support Wire Guide 5 G531 TSCMG E-LESDC Lunderquist Extra-Stiff Extended Double Curved Exchange Support Wire Guide 5 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. 22

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