Physician s pocket reference guide Indications for use Component ordering information Introduction system information Graft specifications Accessory products Zenith ENDOVASCULAR GRAFTS United States cookmedical.com
Achieving a durable aortic repair is the foundation of the Zenith design philosophy. For complete instructions for use (IFUs), go to ifu.cookmedical.com/ifupub/ searchifu.jsf. Additional information may be found at cookmedical.com/aortic-intervention or zenithalphathoracic.cookmedical.com.
Endovascular grafts Abdominal Zenith Flex (includes deployment overview)...4 Zenith Renu... Fenestrated Zenith Fenestrated... 2 Iliac Legs Zenith Spiral-Z... Thoracic Zenith Alpha Thoracic (includes deployment overview)... 4 Zenith TX2 (includes deployment overview)... 5 Accessories for endovascular procedures Access Percutaneous Entry Thinwall Needle One-Part... 7 Micropuncture Introducer Sets... 7 Dilators and Introducers Endovascular Dilator Sets... 0 Performer Introducers... Flexor Ansel Guiding Sheaths with High-Flex Dilator... 2 Large Check-Flo Performer Introducers with Radiopaque Band... Check-Flo Extra-Large Introducers... 4 Catheters CXI Support Catheters... 5 CrossCath Support Catheters... Slip-Cath Beacon Tip Hydrophilic Angiographic Catheters... 7 Aurous Centimeter Sizing Catheters... Beacon Tip Seeking Catheters... Beacon Tip Torcon NB Advantage Angiographic Catheters... 0 Embolization Coils Tornado Platinum Embolization Coils... Nester Platinum Embolization Coils... 2 Balloon Catheters Coda Balloon Catheters... Vascular Retriever Indy OTW Vascular Retrievers... 4 Wire Guides Roadrunner UniGlide Hydrophilic Wire Guides... 5 Safe-T-J Rosen Catheter Exchange Wire Guides... Bentson Fixed Core Wire Guides... 7 Lunderquist Extra-Stiff Wire Guides... Amplatz Support Wire Guides... Contents
Time-tested accuracy and durability.
Indications for Use < 45º -2 5 < 0º > 0 (preferably 20 ) > 0 (preferably 20 ) 7.5 7.5-20 Indications for Use Patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair Zenith Flex AAA 5 nonaneurysmal infrarenal neck Aortic Fixation Site Diameter Angulation/ Curvature Ipsilateral Iliac Fixation Site 2 (measured outer wall to outer wall) Angle < 0 degrees relative to the long axis of the aneurysm. Angle < 45 degrees relative to the axis of the suprarenal aorta Distal fixation site >0 in length and 7.5 20 in diameter (measured outer wall to outer wall) Contralateral Iliac Fixation Site Distal fixation site >0 in length and 7.5 20 in diameter (measured outer wall to outer wall) Indications Access Introducer Diameters Contraindications Adequate femoral/iliac access compatible with the required introduction systems 2 grafts: ID Fr (.0 ) OD 7. 2 2 grafts: ID 20 Fr (.7 ) OD 7.7 grafts: ID Fr (7. ) OD.5 Patients with known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene or gold Patients with a systemic infection who may be at increased risk of endovascular graft infection
Bifurcated Main Body Grafts Order Number Diameter Reference Part Number Aortic Vessel OD Main Body Diameter Main Body Contralateral Introducer Sheath ID/OD Fr ()/ G4402 TFFB--2-ZT - 2 (.0)/7. G440 TFFB---ZT - (.0)/7. G4404 TFFB---ZT - (.0)/7. G4405 TFFB--25-ZT - 25 (.0)/7. G440 TFFB--0-ZT - 0 (.0)/7. 24 Diameter G4407 TFFB-24-2-ZT 20-2 24 2 (.0)/7. G440 TFFB-24--ZT 20-2 24 (.0)/7. G440 TFFB-24--ZT 20-2 24 (.0)/7. G440 TFFB-24-25-ZT 20-2 24 25 (.0)/7. G44 TFFB-24-0-ZT 20-2 24 0 (.0)/7. 2 Diameter G442 TFFB-2-2-ZT 2 2 (.0)/7. G44 TFFB-2--ZT 2 (.0)/7. G44 TFFB-2--ZT 2 (.0)/7. G445 TFFB-2-25-ZT 2 25 (.0)/7. G44 TFFB-2-0-ZT 2 0 (.0)/7. 2 Diameter G44 TFFB-2-2-ZT 2-24 2 2 20 (.7)/7.7 G44 TFFB-2--ZT 2-24 2 20 (.7)/7.7 G44 TFFB-2--ZT 2-24 2 20 (.7)/7.7 G4420 TFFB-2-25-ZT 2-24 2 25 20 (.7)/7.7 G442 TFFB-2-0-ZT 2-24 2 0 20 (.7)/7.7 0 Diameter G44 TFFB-0-2-ZT 25-2 0 2 20 (.7)/7.7 G442 TFFB-0--ZT 25-2 0 20 (.7)/7.7 G4424 TFFB-0--ZT 25-2 0 20 (.7)/7.7 G4425 TFFB-0-25-ZT 25-2 0 25 20 (.7)/7.7 G442 TFFB-0-0-ZT 25-2 0 0 20 (.7)/7.7 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Zenith Flex AAA Bifur. Main Body 7
Bifurcated Main Body Grafts (Continued) Order Number Reference Part Number Aortic Vessel OD Main Body Diameter Main Body Contralateral Introducer Sheath ID/OD Fr ()/ 2 Diameter G4427 TFFB-2-2-ZT 27-2 2 2 20 (.7)/7.7 G442 TFFB-2--ZT 27-2 2 20 (.7)/7.7 G442 TFFB-2--ZT 27-2 2 20 (.7)/7.7 G440 TFFB-2-25-ZT 27-2 2 25 20 (.7)/7.7 G44 TFFB-2-0-ZT 27-2 2 0 20 (.7)/7.7 Diameter G442 TFFB--5-ZT 2-2 5 (7.)/.5 G44 TFFB---ZT 2-2 (7.)/.5 G444 TFFB---ZT 2-2 (7.)/.5 G445 TFFB---ZT 2-2 (7.)/.5 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Zenith Flex AAA Z-Trak Introduction System for Main Body Grafts -2 grafts: Fr (.0 ) ID/7. OD 2-2 grafts: 20 Fr (.7 ) ID/7.7 OD grafts: Fr (7. ) ID/.5 OD cm 40 cm Bifur. Main Body
Bifurcated Main Body Grafts, 24, 2, 2, 0, 2, 24, 2, 2, 0, 2, 24, 2, 2, 0, 2 2 2 2 2 2 5 2 5 2 2 2 2 5 5 5 2 2 2 2 2 5 2 2 2 Bifur. Main Body Zenith Flex AAA Note: Ipsilateral and contralateral limb diameters on all diameter main body grafts are. TFFB-XX-YY-ZT TFFB-(main body diameter)-(main body contralateral length)-zt Note: All measurements are in millimeters. The black numbers on the illustrations indicate stent lengths. The red numbers indicate gap lengths. Gap lengths are approximate. Contralateral and ipsilateral iliac legs: Refer to pages - of this pocket guide for Spiral-Z AAA Iliac Leg Grafts.
Bifurcated Main Body Grafts (Continued), 24, 2, 2, 0, 2, 24, 2, 2, 0, 2 55 2 2 5 5 5 25 0 2 2 2 2 2 2 2 2 5 2 0 25 2 2 2 5 Zenith Flex AAA 2 2 2 2 2 2 2 2 Bifur. Main Body 0 2 2 2 2 2 2 2 2 2 2 2 2 2 Note: Ipsilateral and contralateral limb diameters on all diameter main body grafts are. 2 2
Ancillary Components Order Number Reference Part Number Diameter Introducer Sheath ID/OD Fr ()/ Main Body Extensions G55204 ESBE---ZT (.0)/7. G55205 ESBE-24--ZT 24 (.0)/7. G5520 ESBE-2--ZT 2 (.0)/7. G55207 ESBE-2--ZT 2 20 (.7)/7.7 G5520 ESBE-0--ZT 0 20 (.7)/7.7 G5520 ESBE-2--ZT 2 20 (.7)/7.7 G5520 ESBE--50-ZT 50 20 (.7)/7.7 Order Number Reference Part Number Diameter Introducer Sheath ID/OD Fr ()/ Main Body Extensions G552 ESBE--5-ZT 5 (.0)/7. G5522 ESBE-24-5-ZT 24 5 (.0)/7. G552 ESBE-2-5-ZT 2 5 (.0)/7. G552 ESBE-2-5-ZT 2 5 20 (.7)/7.7 G5525 ESBE-0-5-ZT 0 5 20 (.7)/7.7 G552 ESBE-2-5-ZT 2 5 20 (.7)/7.7 G552 ESBE--7-ZT 7 20 (.7)/7.7 Zenith Flex AAA Order Number Converters Reference Part Number Proximal Diameter Distal Diameter Introducer Sheath ID/OD Fr ()/ G55 ESC-24-2-0-ZT 24 2 0 (.0)/7. G552 ESC-2-2-0-ZT 2 2 0 20 (.7)/7.7 G55 ESC-2-2-0-ZT 2 2 0 20 (.7)/7.7 G554 ESC--2-2-ZT 2 2 20 (.7)/7.7 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Components
Ancillary Components (Continued) Order Number Reference Part Number Diameter Introducer Sheath ID/OD Fr ()/ Iliac Plugs G505 ZIP--0-ZT 0 (4.7)/5.4 G50 ZIP--0-ZT 0 (4.7)/5.4 G507 ZIP-20-0-ZT 20 0 (5.)/.0 G50 ZIP-24-0-ZT 24 0 (5.)/.0 Order Number Reference Part Number Proximal Diameter Distal Diameter Introducer Sheath ID/OD Fr ()/ Zenith Flex AAA Iliac Leg Extension G557 ESLE-2-55-ZT 2 2 55 (4.7)/5.4 G55 ESLE--55-ZT 55 (4.7)/5.4 G55 ESLE--55-ZT 55 (4.7)/5.4 G55200 ESLE--55-ZT 55 (5.)/.0 G5520 ESLE-20-55-ZT 20 20 55 (5.)/.0 G55202 ESLE--55-ZT 55 (5.)/.0 G5520 ESLE-24-55-ZT 24 24 55 (5.)/.0 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Components 2
Ancillary Components Main Body Extensions, 24, 2, 2, 0, 2, 24, 2, 2, 0, 2 5 50 7 Converters 24, 2, 2 0 2 2 2 Zenith Flex AAA Iliac Plugs Iliac Leg Extensions,, 20, 24 0 2,,,, 20,, 24 55 Components Main Body Extensions ESBE-XX-YY-ZT ESBE-(diameter)-(length)-ZT Iliac Plugs ZIP-XX-YY-ZT ZIP-(diameter)-(length)-ZT Converters ESC-XX-YY-ZZ-ZT ESC-(proximal diameter)-(distal diameter)-(length)-zt Iliac Leg Extensions ESLE-XX-YY-ZT ESLE-(diameter)-(length)-ZT Note: All measurements are in millimeters. The black numbers on the illustrations indicate stent lengths.
Deployment Overview* a 2 MAIN BODY PLACEMENT Note: Before insertion, position main body delivery system on patient s abdomen under fluoroscopy to determine the orientation of the contralateral limb radiopaque marker. Insert main body delivery system over a stiff wire into the femoral artery. Advance delivery system until the four gold radiopaque markers (which are positioned 2 from the most proximal segment of the graft material) are just inferior to the most inferior renal orifice. Deploy the first two covered stents by withdrawing the sheath while monitoring device location. Check position of the contralateral limb radiopaque marker and location of renal arteries. Note: A marker formation of indicates an anterior position of the short contralateral limb. Proceed with deployment until contralateral limb is fully deployed. Stop withdrawing sheath. CONTRALATERAL ILIAC WIRE GUIDE PLACEMENT Manipulate catheter and wire guide through open end of contralateral limb into body of the endovascular graft. A-P and oblique fluoroscopic views aid in verification of device cannulation. Advance angiographic catheter over the wire into the body of the endovascular graft. Perform angiography to confirm position, then advance wire guide until it curves inside the body of the endovascular graft. Zenith Flex AAA MAIN BODY PROXIMAL (TOP) DEPLOYMENT Remove the safety lock from the top stent trigger-wire release mechanism. Withdraw and remove the trigger-wire release mechanism. Loosen the pin vise and deploy the suprarenal stent by advancing the top cap inner cannula to 2 at a time until the top stent is fully deployed. Advance the top cap inner cannula an additional to 2 cm and retighten the pin vise. Advance the contralateral wire guide into the thoracic aorta. Note: Once the barbed suprarenal stent has been deployed, further attempts to reposition the graft are not recoended. Deployment 4 CONTRALATERAL ILIAC LEG PLACEMENT AND DEPLOYMENT Introduce the contralateral iliac leg delivery system over a stiff wire into the femoral artery. Advance slowly until the iliac leg graft overlaps at least one full iliac leg stent inside the contralateral limb of the main body. Reposition the iliac leg graft if necessary to ensure both internal iliac patency and a minimum of one full iliac leg stent overlap (maximum 0 ) within the main body endovascular graft. To deploy, hold the iliac leg graft in position with the gray positioner while withdrawing the sheath. Stop withdrawing the sheath as soon as the distal end of the iliac leg graft is released. Verify iliac leg graft position, loosen pin vise and retract inner cannula to dock tapered dilator to gray positioner. Tighten pin vise and withdraw gray positioner with secured inner cannula. Close the Captor Hemostatic Valve on the Flexor Introducer Sheath. 5 MAIN BODY DISTAL (BOTTOM) DEPLOYMENT Fully deploy the ipsilateral limb of the main body by withdrawing the sheath until the most distal stent has expanded. Stop withdrawing sheath. Remove the safety lock from the ipsilateral limb trigger-wire release mechanism. Withdraw and remove the trigger-wire release mechanism.
Deployment Overview* (Continued) 7 DOCKING OF TOP CAP Loosen pin vise and advance the gray positioner over the inner cannula until it docks with the top cap. Retighten pin vise and withdraw the entire top cap and gray positioner through the endovascular graft and through the sheath by pulling on the inner cannula. Note: Maintain position of sheath and wire guide. Close the Captor Hemostatic Valve on the Flexor Introducer Sheath. IPSILATERAL ILIAC LEG PLACEMENT AND DEPLOYMENT Use the main body graft stiff wire and sheath to introduce the ipsilateral iliac leg graft. Advance ipsilateral iliac leg delivery system into the main body sheath. Advance slowly until the ipsilateral iliac leg graft overlaps a minimum of one full iliac leg stent inside the ipsilateral limb of the main body. Reposition the iliac leg graft if necessary to ensure internal iliac patency. To deploy, stabilize the iliac leg graft with the gray positioner while withdrawing the iliac leg sheath. Verify iliac leg graft position, loosen pin vise and retract inner cannula to dock tapered dilator to gray positioner. Tighten pin vise and withdraw gray positioner with secured inner cannula. Close the Captor Hemostatic Valve on the Flexor Introducer Sheath. MOLDING BALLOON INSERTION Advance the molding balloon over the stiff wire guide and through the hemostatic valve of the main body introduction system to the level of the renal arteries. Expand the molding balloon with diluted contrast media in the area of the most proximal covered stent and the infrarenal neck, starting proximally and working in the distal direction. Caution: Confirm complete balloon deflation prior to repositioning. Caution: Captor Hemostatic Valve must be open prior to repositioning of molding balloon. Withdraw the molding balloon to both the ipsilateral limb overlap and the ipsilateral distal fixation site and expand. Deflate and remove molding balloon. Transfer the molding balloon onto the contralateral stiff wire guide and into the contralateral iliac leg introduction system. Advance molding balloon to the contralateral limb overlap and expand. Withdraw the molding balloon to the contralateral iliac leg/vessel distal fixation and expand. Caution: Do not inflate balloon in vessel outside of graft. Deflate and remove molding balloon and replace it with an angiographic catheter to perform completion angiography. *This deployment overview is an outline highlighting the deployment process for the Zenith Flex AAA Endovascular Graft. The Instructions for Use booklet should be consulted for a more thorough examination of the deployment protocol, indications, contraindications, warnings, and precautions. Zenith Flex AAA Deployment 5
Helps restore graft-to-vessel fixation and seal.
Indications for Use < 45º < 45º < 0º < 0º Zenith Renu AAA Ancillary Indications Indications for Use Aortic Fixation Site Diameter Angulation/ Curvature Converter Distal Fixation Site Main Body Distal Fixation Site Access Introducer Diameters Contraindications Secondary endovascular intervention in patients having received prior endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms in which there is inadequate proximal fixation or seal. Lowest renal artery to bifurcation of previously placed graft of > 4 for the main body extension and > 7 for the converter. 2 (measured outer wall to outer wall) Angle < 0 degrees relative to the long axis of the aneurysm Angle < 45 degrees relative to the axis of the suprarenal aorta For the converter used without an iliac leg, distal fixation site within a graft segment of 2 in diameter and (one Cook-Z stent) in length, with more overlap length being preferred. For the converter used in combination with the iliac leg, distal fixation site 7.5 20 in diameter (measured outer wall to outer wall) and > 0 in length with 20 to 0 being preferred. Main body extension distal fixation site within a graft segment of 4 diameter and at least one Cook-Z stent in length, with more overlap length being preferred. Adequate femoral/iliac access compatible with the required introduction systems 2 grafts: ID Fr (.0 ) OD 7. 2 2 grafts: ID 20 Fr (.7 ) OD 7.7 grafts: ID Fr (7. ) OD.5 Patients with known sensitivities or allergies to stainless steel, polyester, solder (tin, silver), nitinol, polypropylene or gold. Patients with a systemic infection who may be at increased risk of endovascular graft infection.
Converters Order Number Reference Part Number Aortic Vessel OD Proximal/ Distal Diameter Proximal/ Distal Total Introducer Sheath ID/OD Fr ()/ Diameter G5555 AX---0-ZT - /2 7/7 0 (.0)/7. G555 AX---25-ZT - /2 7/ 25 (.0)/7. G5557 AX-2---ZT - /2 5/54 (.0)/7. 24 Diameter G55 AX--24-0-ZT 20-2 24/2 7/7 0 (.0)/7. G552 AX--24-25-ZT 20-2 24/2 7/ 25 (.0)/7. G55 AX-2-24--ZT 20-2 24/2 5/54 (.0)/7. 2 Diameter G557 AX--2-0-ZT 2/2 7/7 0 (.0)/7. G55 AX--2-25-ZT 2/2 7/ 25 (.0)/7. G55 AX-2-2--ZT 2/2 5/54 (.0)/7. 2 Diameter G5574 AX--2-0-ZT 2-24 2/2 7/7 0 20 (.7)/7.7 G5575 AX--2-25-ZT 2-24 2/2 7/ 25 20 (.7)/7.7 G557 AX-2-2--ZT 2-24 2/2 5/54 20 (.7)/7.7 0 Diameter G550 AX--0-0-ZT 25-2 0/2 7/7 0 20 (.7)/7.7 G55 AX--0-25-ZT 25-2 0/2 7/ 25 20 (.7)/7.7 G552 AX-2-0--ZT 25-2 0/2 5/54 20 (.7)/7.7 2 Diameter G55 AX--2-0-ZT 27-2 2/2 7/7 0 20 (.7)/7.7 G557 AX--2-25-ZT 27-2 2/2 7/ 25 20 (.7)/7.7 G55 AX-2-2--ZT 27-2 2/2 5/54 20 (.7)/7.7 Diameter G552 AX----ZT 2-2 /2 52/4 (7.)/.5 G554 AX-2--27-ZT 2-2 /2 0/47 27 (7.)/.5 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Zenith Renu AAA Ancillary Converters Z-Trak Introduction System for Renu Converters -2 grafts: Fr (.0 ) ID/7. OD 2-2 grafts: 20 Fr (.7 ) ID/7.7 OD grafts: Fr (7. ) ID/.5 OD cm 40 cm
Converters, 24, 2, 2, 0, 2, 24, 2, 2, 0, 2 2 2 2 Zenith Renu AAA Ancillary Converters 20 7 7 5 54 5 0 4 2, 24, 2, 2, 0, 2 2 5 5 2 AX-(2)-XX-YY-ZT 52 0 47 AX-(2)-(proximal diameter)-(total length)-zt Note: All measurements are in millimeters. The black numbers on the illustrations indicate stent lengths. The red numbers indicate gap lengths. Gap lengths are approximate. Contralateral and ipsilateral iliac legs: Refer to pages - of this pocket guide for Spiral-Z AAA Iliac Leg Grafts. 2 2 2 27 7 5 2 25
Main Body Extensions Order Number Reference Part Number Aortic Vessel OD Diameter Introducer Sheath ID/OD Fr ()/ Diameter G557 RX--4-ZT - 4 (.0)/7. G55 RX--2-ZT - 2 (.0)/7. 24 Diameter G55400 RX-24-4-ZT 20-2 24 4 (.0)/7. G5540 RX-24-2-ZT 20-2 24 2 (.0)/7. 2 Diameter G5540 RX-2-4-ZT 2 4 (.0)/7. G55404 RX-2-2-ZT 2 2 (.0)/7. 2 Diameter G5540 RX-2-4-ZT 2-24 2 4 20 (.7)/7.7 G55407 RX-2-2-ZT 2-24 2 2 20 (.7)/7.7 0 Diameter G5540 RX-0-4-ZT 25-2 0 4 20 (.7)/7.7 G5540 RX-0-2-ZT 25-2 0 2 20 (.7)/7.7 2 Diameter G5542 RX-2-4-ZT 27-2 2 4 20 (.7)/7.7 G554 RX-2-2-ZT 27-2 2 2 20 (.7)/7.7 Diameter G5545 RX--54-ZT 2-2 54 (7.)/.5 G554 RX--77-ZT 2-2 77 (7.)/.5 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Z-Trak Introduction System for Renu Main Body Extensions -2 grafts: Fr (.0 ) ID/7. OD 2-2 grafts: 20 Fr (.7 ) ID/7.7 OD grafts: Fr (7. ) ID/.5 OD Zenith Renu AAA Ancillary Main Body Ext. 2 cm 40 cm
Main Body Extensions 2 2 2 5 4 54 5 5 2, 24, 2, 2, 0, 2, 24, 2, 2, 0, 2 Zenith Renu AAA Ancillary 2 77 Main Body Ext. RX-XX-YY-ZT RX-(diameter)-(length)-ZT Note: All measurements are in millimeters. The black numbers on the illustrations indicate stent lengths. The red numbers indicate gap lengths. Gap lengths are approximate.
Helps deliver a durable repair in complex infrarenal anatomy.
Indications for Use < 45º - 4 < 45º > 0 > 0-2 Ipsilateral 7-2 Contralateral Zenith Fenestrated AAA Indications for Use Aortic Fixation Site Diameter Angulation/ Curvature Endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair. 4 nonaneurysmal neck - (measured outer wall to outer wall) Angle < 45 degrees relative to the long axis of the aneurysm Angle < 45 degrees relative to the axis of the suprarenal aorta Ipsilateral Iliac Fixation Site Distal fixation site > 0 in length and 2 in diameter (measured outer wall to outer wall) Indications Contralateral Iliac Fixation Site Access Introducer Diameters Distal fixation site > 0 in length and 7 2 in diameter (measured outer wall to outer wall) Adequate femoral/iliac access compatible with the required introduction systems ID 20 Fr (.7 ) OD 7.7 ID Fr (7. ) OD.5 24 Contraindications Patients with known sensitivities or allergies to stainless steel, polyester, nitinol, solder (tin, silver), polypropylene, or gold Patients with systemic or local infection that may increase the risk of endovascular graft infection.
Proximal Body Grafts Order Number Reference Part Number Aortic Vessel OD Proximal Body Diameter Proximal Body Introducer Sheath ID/OD Fr ()/ One Proximal Internal Stent 24 Diameter G2502 ZFEN-P--24-7-R -2 24 7 20 (.7)/7.7 G2507 ZFEN-P--24--R -2 24 20 (.7)/7.7 G252 ZFEN-P--24-0-R -2 24 0 20 (.7)/7.7 G25 ZFEN-P--24-2-R -2 24 2 20 (.7)/7.7 2 Diameter G250 ZFEN-P--2-7-R 2-2 7 20 (.7)/7.7 G250 ZFEN-P--2--R 2-2 20 (.7)/7.7 G25 ZFEN-P--2-0-R 2-2 0 20 (.7)/7.7 G25 ZFEN-P--2-2-R 2-2 2 20 (.7)/7.7 2 Diameter G2504 ZFEN-P--2-7-R 2-24 2 7 20 (.7)/7.7 G250 ZFEN-P--2--R 2-24 2 20 (.7)/7.7 G25 ZFEN-P--2-0-R 2-24 2 0 20 (.7)/7.7 G25 ZFEN-P--2-2-R 2-24 2 2 20 (.7)/7.7 0 Diameter G2505 ZFEN-P--0-7-R 24-2 0 7 20 (.7)/7.7 G250 ZFEN-P--0--R 24-2 0 20 (.7)/7.7 G255 ZFEN-P--0-0-R 24-2 0 0 20 (.7)/7.7 G2520 ZFEN-P--0-2-R 24-2 0 2 20 (.7)/7.7 2 Diameter G250 ZFEN-P--2-7-R 2-2 2 7 20 (.7)/7.7 G25 ZFEN-P--2--R 2-2 2 20 (.7)/7.7 G25 ZFEN-P--2-0-R 2-2 2 0 20 (.7)/7.7 G252 ZFEN-P--2-2-R 2-2 2 2 20 (.7)/7.7 4 Diameter G25 ZFEN-P--4-4-R 2-2 4 4 20 (.7)/7.7 G2524 ZFEN-P--4--R 2-2 4 20 (.7)/7.7 G252 ZFEN-P--4--R 2-2 4 20 (.7)/7.7 G252 ZFEN-P--4-2-R 2-2 4 2 20 (.7)/7.7 Diameter G252 ZFEN-P---4-R 2-4 (7.)/.5 G2525 ZFEN-P----R 2- (7.)/.5 G2527 ZFEN-P----R 2- (7.)/.5 G252 ZFEN-P---2-R 2-2 (7.)/.5 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. H&L-B One-Shot Introduction System for Proximal Body Grafts 20 Fr (.7 ) ID/7.7 OD, Fr (7. ) ID/.5 OD Zenith Fenestrated AAA Proximal Body 25 cm 50 cm
Proximal Body Grafts One Internal Proximal Stent 24, 2, 2, 0, 2 24, 2, 2, 0, 2 24, 2, 2, 0, 2 24, 2, 2, 0, 2 2 2 2 2 4 4 4 4 Zenith Fenestrated AAA Proximal Body 4, 4, 4, 4, 2 2 2 2 7 4 0 4 4 4 4 2 2 2 ZFEN-P--XX-YY-R ZFEN-P--(proximal body diameter)-(proximal body length)-r Note: All measurements are in millimeters. The black numbers on the illustrations indicate stent lengths. The red numbers indicate gap lengths. Gap lengths are approximate. Contralateral and ipsilateral iliac legs: Refer to pages - of this pocket guide for Spiral-Z AAA Iliac Leg Grafts.
Proximal Body Grafts Order Number Reference Part Number Aortic Vessel OD Proximal Body Diameter Proximal Body Introducer Sheath ID/OD Fr ()/ Two Proximal Internal Stents 24 Diameter G250 ZFEN-P-2-24-4-R -2 24 4 20 (.7)/7.7 G255 ZFEN-P-2-24-0-R -2 24 0 20 (.7)/7.7 G2540 ZFEN-P-2-24-24-R -2 24 24 20 (.7)/7.7 2 Diameter G25 ZFEN-P-2-2-4-R 2-2 4 20 (.7)/7.7 G25 ZFEN-P-2-2-0-R 2-2 0 20 (.7)/7.7 G254 ZFEN-P-2-2-24-R 2-2 24 20 (.7)/7.7 2 Diameter G252 ZFEN-P-2-2-4-R 2-24 2 4 20 (.7)/7.7 G257 ZFEN-P-2-2-0-R 2-24 2 0 20 (.7)/7.7 G2542 ZFEN-P-2-2-24-R 2-24 2 24 20 (.7)/7.7 0 Diameter G25 ZFEN-P-2-0-4-R 24-2 0 4 20 (.7)/7.7 G25 ZFEN-P-2-0-0-R 24-2 0 0 20 (.7)/7.7 G254 ZFEN-P-2-0-24-R 24-2 0 24 20 (.7)/7.7 2 Diameter G254 ZFEN-P-2-2-4-R 2-2 2 4 20 (.7)/7.7 G25 ZFEN-P-2-2-0-R 2-2 2 0 20 (.7)/7.7 G2544 ZFEN-P-2-2-24-R 2-2 2 24 20 (.7)/7.7 4 Diameter G2545 ZFEN-P-2-4-07-R 2-2 4 07 20 (.7)/7.7 G2547 ZFEN-P-2-4--R 2-2 4 20 (.7)/7.7 G254 ZFEN-P-2-4-7-R 2-2 4 7 20 (.7)/7.7 Diameter G254 ZFEN-P-2--07-R 2-07 (7.)/.5 G254 ZFEN-P-2---R 2- (7.)/.5 G2550 ZFEN-P-2--7-R 2-7 (7.)/.5 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Zenith Fenestrated AAA Proximal Body H&L-B One-Shot Introduction System for Proximal Body Grafts 20 Fr (.7 ) ID/7.7 OD Fr (7. ) ID/.5 OD 27 cm 50 cm
Proximal Body Grafts Two Internal Proximal Stents 24, 2, 2, 0, 2 24, 2, 2, 0, 2 24, 2, 2, 0, 2 2 2 2 4 4 4 Zenith Fenestrated AAA Proximal Body 4 0 4, 4, 4, 2 2 2 4 4 4 07 24 7 2 ZFEN-P-2-XX-YY-R ZFEN-P-2-(proximal body diameter)-(proximal body length)-r Note: All measurements are in millimeters. The black numbers on the illustrations indicate stent lengths. The red numbers indicate gap lengths. Gap lengths are approximate. Contralateral and ipsilateral iliac legs: Refer to pages - of this pocket guide for Spiral-Z AAA Iliac Leg Grafts.
Distal Bifurcated Body Grafts Order Number Reference Part Number Ipsilateral Leg Diameter Distal Body Distal Leg Introducer Sheath ID/OD Fr ()/ Distal Bifurcated Body Graft G255 ZFEN-D-2-2-7-C 2 7 2 20 (.7)/7.7 G2554 ZFEN-D-2-2--C 2 2 20 (.7)/7.7 G2500 ZFEN-D-2-2-0-C 2 0 2 20 (.7)/7.7 G250 ZFEN-D-2-2-2-C 2 2 2 20 (.7)/7.7 G25 ZFEN-D-2-45-7-C 2 7 45 20 (.7)/7.7 G255 ZFEN-D-2-45--C 2 45 20 (.7)/7.7 G25 ZFEN-D-2-45-0-C 2 0 45 20 (.7)/7.7 G257 ZFEN-D-2-45-2-C 2 2 45 20 (.7)/7.7 G2577 ZFEN-D-2-2-7-C 2 7 2 20 (.7)/7.7 G250 ZFEN-D-2-2--C 2 2 20 (.7)/7.7 G254 ZFEN-D-2-2-0-C 2 0 2 20 (.7)/7.7 G25 ZFEN-D-2-2-2-C 2 2 2 20 (.7)/7.7 G2552 ZFEN-D--2-7-C 7 2 20 (.7)/7.7 G2555 ZFEN-D--2--C 2 20 (.7)/7.7 G2557 ZFEN-D--2-0-C 0 2 20 (.7)/7.7 G255 ZFEN-D--2-2-C 2 2 20 (.7)/7.7 G252 ZFEN-D--45-7-C 7 45 20 (.7)/7.7 G25 ZFEN-D--45--C 45 20 (.7)/7.7 G2570 ZFEN-D--45-0-C 0 45 20 (.7)/7.7 G2574 ZFEN-D--45-2-C 2 45 20 (.7)/7.7 G252 ZFEN-D--2-7-C 7 2 20 (.7)/7.7 G25 ZFEN-D--2--C 2 20 (.7)/7.7 G255 ZFEN-D--2-0-C 0 2 20 (.7)/7.7 G25 ZFEN-D--2-2-C 2 2 20 (.7)/7.7 G255 ZFEN-D-20-2-7-C 20 7 2 20 (.7)/7.7 G255 ZFEN-D-20-2--C 20 2 20 (.7)/7.7 G255 ZFEN-D-20-2-0-C 20 0 2 20 (.7)/7.7 G250 ZFEN-D-20-2-2-C 20 2 2 20 (.7)/7.7 G25 ZFEN-D-20-45-7-C 20 7 45 20 (.7)/7.7 G257 ZFEN-D-20-45--C 20 45 20 (.7)/7.7 G257 ZFEN-D-20-45-0-C 20 0 45 20 (.7)/7.7 G2575 ZFEN-D-20-45-2-C 20 2 45 20 (.7)/7.7 G257 ZFEN-D-20-2-7-C 20 7 2 20 (.7)/7.7 G252 ZFEN-D-20-2--C 20 2 20 (.7)/7.7 G25 ZFEN-D-20-2-0-C 20 0 2 20 (.7)/7.7 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Zenith Fenestrated AAA Distal Bifur. Body 2
Distal Bifurcated Body Grafts (Continued) Order Number Reference Part Number Ipsilateral Leg Diameter Distal Body Distal Leg Introducer Sheath ID/OD Fr ()/ Zenith Fenestrated AAA Distal Bifurcated Body Graft G250 ZFEN-D-20-2-2-C 20 2 2 20 (.7)/7.7 G254 ZFEN-D-24-45-7-C 24 7 45 20 (.7)/7.7 G25 ZFEN-D-24-45--C 24 45 20 (.7)/7.7 G2572 ZFEN-D-24-45-0-C 24 0 45 20 (.7)/7.7 G257 ZFEN-D-24-45-2-C 24 2 45 20 (.7)/7.7 G257 ZFEN-D-24-2-7-C 24 7 2 20 (.7)/7.7 G25 ZFEN-D-24-2--C 24 2 20 (.7)/7.7 G257 ZFEN-D-24-2-0-C 24 0 2 20 (.7)/7.7 G25 ZFEN-D-24-2-2-C 24 2 2 20 (.7)/7.7 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. H&L-B One-Shot Introduction System for Distal Body Grafts 20 Fr (.7 ) ID/7.7 OD cm 40 cm Distal Bifur. Body 0
Distal Bifurcated Body Grafts 2,, 20 7 45 2,, 20, 24 7 2 2,, 20, 24 2 45 2,, 20 7 2 2,, 20, 24 2,, 20, 24 2 Zenith Fenestrated AAA Distal Bifur. Body ZFEN-D-XX-YY-ZZ-C ZFEN-D-(ipsilateral leg diameter)-(distal leg length)-(distal body length)-c Note: All measurements are in millimeters. The black numbers on the illustrations indicate stent lengths. The red numbers indicate gap lengths. Gap lengths are approximate. Contralateral and ipsilateral iliac legs: Refer to pages - of this pocket guide for Spiral-Z AAA Iliac Leg Grafts.
Distal Bifurcated Body Grafts (Continued) Zenith Fenestrated AAA Distal Bifur. Body 2 0 0 0 2 45 2 2,, 20 2,, 20, 24 2,, 20, 24 2 2 2 45 2,, 20 2,, 20, 24 2,, 20, 24 2 2
Maintains patency and conformability in a variety of iliac anatomy. Zenith Spiral-Z AAA ILIAC LEG GRAFT Zenith Flex Zenith Renu Zenith Fenestrated
Indications for Use > 0 (preferably 20 ) > 0 (preferably 20 ) Compatible with required introduction systems 7.5-20 Zenith Spiral-Z AAA Indications Indications for Use Ipsilateral Iliac Fixation Site Contralateral Iliac Fixation Site Access Introducer Diameters Contraindications For use with the Zenith AAA Endovascular Graft family of products, during either a primary or a secondary procedure in patients who have adequate iliac/femoral access compatible with the required introduction systems. Distal fixation site >0 in length and 7.5 20 in diameter (measured outer wall to outer wall) Distal fixation site >0 in length and 7.5 20 in diameter (measured outer wall to outer wall) Adequate femoral/iliac access compatible with the required introduction systems - grafts: ID Fr (4.7 ) OD 5.4 20-24 grafts: ID Fr (5. ) OD.0 Patients with known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, or gold Patients with a systemic infection who may be at increased risk of endovascular graft infection 4
Contralateral/Ipsilateral Iliac Leg Grafts Order Number Reference Part Number Iliac Leg Distal Diameter Iliac Leg Working Introducer Sheath ID/OD Fr ()/ Diameter G552 ZSLE---ZT (4.7)/5.4 G552 ZSLE--5-ZT 5 (4.7)/5.4 G550 ZSLE--74-ZT 74 (4.7)/5.4 G55 ZSLE--0-ZT 0 (4.7)/5.4 G552 ZSLE--07-ZT 07 (4.7)/5.4 G55 ZSLE---ZT (4.7)/5.4 Diameter G554 ZSLE---ZT (4.7)/5.4 G555 ZSLE--5-ZT 5 (4.7)/5.4 G55 ZSLE--74-ZT 74 (4.7)/5.4 G557 ZSLE--0-ZT 0 (4.7)/5.4 G55 ZSLE--07-ZT 07 (4.7)/5.4 G55 ZSLE---ZT (4.7)/5.4 Diameter G5520 ZSLE---ZT (4.7)/5.4 G552 ZSLE--5-ZT 5 (4.7)/5.4 G5522 ZSLE--74-ZT 74 (4.7)/5.4 G552 ZSLE--0-ZT 0 (4.7)/5.4 G5524 ZSLE--07-ZT 07 (4.7)/5.4 G5525 ZSLE---ZT (4.7)/5.4 Diameter G552 ZSLE---ZT (4.7)/5.4 G5527 ZSLE--5-ZT 5 (4.7)/5.4 G552 ZSLE--74-ZT 74 (4.7)/5.4 G552 ZSLE--0-ZT 0 (4.7)/5.4 20 Diameter G55240 ZSLE-20--ZT 20 (5.)/.0 G5524 ZSLE-20-5-ZT 20 5 (5.)/.0 G55242 ZSLE-20-74-ZT 20 74 (5.)/.0 G5524 ZSLE-20-0-ZT 20 0 (5.)/.0 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Zenith Spiral-Z AAA Iliac Legs 5
Contralateral/Ipsilateral Iliac Leg Grafts (Continued) Order Number Reference Part Number Iliac Leg Distal Diameter Iliac Leg Working Introducer Sheath ID/OD Fr ()/ 24 Diameter G55244 ZSLE-24--ZT 24 (5.)/.0 G55245 ZSLE-24-5-ZT 24 5 (5.)/.0 G5524 ZSLE-24-74-ZT 24 74 (5.)/.0 G55247 ZSLE-24-0-ZT 24 0 (5.)/.0 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Z-Trak Introduction System for Iliac Legs grafts: Fr (4.7 ) ID/5.4 OD 20 24 grafts: Fr (5. ) ID/.0 OD Zenith Spiral-Z AAA cm 7 cm Iliac Legs
Contralateral/Ipsilateral Iliac Leg Grafts 40 42 42 42 42 5 74 0 07 40 42 42 42 42 5 74 0 07 Zenith Spiral-Z AAA Iliac Legs 7 ZSLE-XX-YY-ZT ZSLE-(distal diameter)-(working length)-zt Note: All measurements are in millimeters. The black numbers on the illustrations indicate stent lengths.
Contralateral/Ipsilateral Iliac Leg Grafts (Continued) 5 74 0 07 Zenith Spiral-Z AAA 57 7 5 74 0 Iliac Legs
Contralateral/Ipsilateral Iliac Leg Grafts (Continued) 20 57 7 5 74 0 20 20 20 20 24 57 7 5 74 0 Zenith Spiral-Z AAA 24 24 24 24 Iliac Legs
Helps treat more patients with TEVAR. Zenith Alpha T HORACIC ENDOVASCULAR GRAFT
Indications for Use Aneurysm or ulcer proximal neck diameter 5-42 proximal neck length 20 distal neck diameter 5-42 le sser great er distal neck length 20 Blunt injury aortic arch radius of curvature 20 proximal neck diameter 5-42 proximal neck length 20 distal neck diameter 5-42 distal neck length 20 Zenith Alpha Thoracic Indications for Use The Zenith Alpha Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissection) having vascular anatomy suitable for endovascular repair including: Iliac/femoral anatomy that is suitable for access with the required introduction systems Nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic lesion: - with a length of at least 20, and - with a diameter measured outer-wall-to-outer-wall of no greater than 42 and no less than 5 Indications 42 Aortic Fixation Site Diameter Angulation/ Curvature Access Introducer Diameters Contraindications Nonaneurysmal aortic necks proximal and distal to the aneurysms, ulcers, or blunt injuries with a length 20 5 42 (measured outer wall to outer wall) A radius of curvature 20 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 0 grafts: ID Fr (5. ) OD.0 2 grafts: ID Fr (.0 ) OD 7. 40 4 grafts: ID 20 Fr (.7 ) OD 7.7 Patients with known sensitivities or allergies to polyester, polypropylene, nitinol, or gold. Patients who have a condition that threatens to infect the endovascular graft.
Proximal Components Order Number Reference Part Number Aortic Vessel OD Diameter Introducer Sheath ID/OD Fr ()/ Diameter G527 ZTA-P--05-W 5-05 (5.)/.0 20 Diameter G52 ZTA-P-20-05-W 20 05 (5.)/.0 Diameter G5 ZTA-P--05-W - 05 (5.)/.0 24 Diameter G5 ZTA-P-24-05-W 20-2 24 05 (5.)/.0 2 Diameter G55 ZTA-P-2-05-W -2 2 05 (5.)/.0 2 Diameter G57 ZTA-P-2-0-W 24-25 2 0 (5.)/.0 G5 ZTA-P-2-55-W 24-25 2 55 (5.)/.0 G540 ZTA-P-2-20-W 24-25 2 20 (5.)/.0 0 Diameter G54 ZTA-P-0-0-W 2-27 0 0 (5.)/.0 G54 ZTA-P-0-55-W 2-27 0 55 (5.)/.0 G544 ZTA-P-0-20-W 2-27 0 20 (5.)/.0 2 Diameter G545 ZTA-P-2-0-W 2-2 2 0 (.0)/7. G547 ZTA-P-2-55-W 2-2 2 55 (.0)/7. G54 ZTA-P-2-20-W 2-2 2 20 (.0)/7. 4 Diameter G54 ZTA-P-4--W 0 4 (.0)/7. G55 ZTA-P-4--W 0 4 (.0)/7. G552 ZTA-P-4-20-W 0 4 20 (.0)/7. Diameter G55 ZTA-P---W -2 (.0)/7. G555 ZTA-P---W -2 (.0)/7. G55 ZTA-P--20-W -2 20 (.0)/7. Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Zenith Alpha Thoracic Prox. Components 4
Proximal Components (continued) Order Number Reference Part Number Aortic Vessel OD Diameter Introducer Sheath ID/OD Fr ()/ Zenith Alpha Thoracic Diameter G557 ZTA-P---W -4 (.0)/7. G55 ZTA-P--7-W -4 7 (.0)/7. G50 ZTA-P--2-W -4 2 (.0)/7. 40 Diameter G5 ZTA-P-40--W 5-40 20 (.7)/7.7 G5 ZTA-P-40-7-W 5-40 7 20 (.7)/7.7 G54 ZTA-P-40-2-W 5-40 2 20 (.7)/7.7 42 Diameter G55 ZTA-P-42-2-W 7-42 2 20 (.7)/7.7 G57 ZTA-P-42--W 7-42 20 (.7)/7.7 G5 ZTA-P-42-5-W 7-42 5 20 (.7)/7.7 44 Diameter G5 ZTA-P-44-25-W 44 25 20 (.7)/7.7 G57 ZTA-P-44--W 44 20 (.7)/7.7 G572 ZTA-P-44-2-W 44 2 20 (.7)/7.7 4 Diameter G57 ZTA-P-4-25-W 40-42 4 25 20 (.7)/7.7 G575 ZTA-P-4--W 40-42 4 20 (.7)/7.7 G57 ZTA-P-4-2-W 40-42 4 2 20 (.7)/7.7 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Prox. Components Introduction System for Proximal Components -0 grafts: Fr (5. ) ID/.0 OD 2- grafts: Fr (.0 ) ID/7. OD 40-4 grafts: 20 Fr (.7 ) ID/7.7 OD 44 cm 5 cm
Proximal Components, 20,, 24, 2 2, 0, 2 2, 0, 2 2, 0, 2 7 7 05 0 55 7 20 7 4, 4, 4,, 40 Zenith Alpha Thoracic 0 20 0 0 0 Prox. Components 45 ZTA-P-XX-YYY-W ZTA-P-(diameter)-(length)-W Note: All measurements are in millimeters. Red numbers indicate gap lengths. Gap lengths are approximate.
Proximal Components (continued), 40, 40 42 42 0 0 0 0 7 0 0 2 2 0 0 Zenith Alpha Thoracic 0 0 0 0 0 0 42 44, 4 44, 4 44, 4 2 2 2 Prox. Components 5 2 2 2 25 2 2 2 2 2 2 2 4 2 2 2 2 2 2
Proximal 4 Tapered Components Order Number Reference Part Number Aortic Vessel OD Proximal Diameter Distal Diameter Introducer Sheath ID/OD Fr ()/ 2 Diameter G055 ZTA-PT-2--05-W 2-2 2 05 (5.)/.0 0 Diameter G072 ZTA-PT-0-2-0-W 2-2 0 2 0 (5.)/.0 2 Diameter G075 ZTA-PT-2-2--W 2-2 2 2 (.0)/7. G ZTA-PT-2-2-20-W 2-2 2 2 20 (.0)/7. 4 Diameter G2 ZTA-PT-4-0--W 0 4 0 (.0)/7. G ZTA-PT-4-0-20-W 0 4 0 20 (.0)/7. Diameter G ZTA-PT--2--W -2 2 (.0)/7. G ZTA-PT--2-20-W -2 2 20 (.0)/7. Diameter G0 ZTA-PT--4-7-W -4 4 7 (.0)/7. G0 ZTA-PT--4-2-W -4 4 2 (.0)/7. 40 Diameter G ZTA-PT-40--7-W 5-40 7 20 (.7)/7.7 G20 ZTA-PT-40--2-W 5-40 2 20 (.7)/7.7 42 Diameter G20 ZTA-PT-42---W 7-42 20 (.7)/7.7 G204 ZTA-PT-42--5-W 7-42 5 20 (.7)/7.7 44 Diameter G20 ZTA-PT-44-40--W 44 40 20 (.7)/7.7 G2 ZTA-PT-44-40-2-W 44 40 2 20 (.7)/7.7 4 Diameter G0 ZTA-PT-4-42--W 40-42 4 42 20 (.7)/7.7 G2 ZTA-PT-4-42-2-W 40-42 4 42 2 20 (.7)/7.7 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Introduction System for Proximal 4 Tapered Components 2-0 grafts: Fr (5. ) ID/.0 OD 2- grafts: Fr (.0 ) ID/7. OD 40-4 grafts: 20 Fr (.7 ) ID/7.7 OD Zenith Alpha Thoracic Prox. Tapered Comp. 47 cm 5 cm
Proximal 4 Tapered Components 2 0 2 2 7 7 7 7 05 0 20 2 Zenith Alpha Thoracic 4 4 20 2 2 Prox. Tapered Comp. 4 0 0 ZTA-PT-XX-YY-ZZZ-W ZTA-PT-(proximal diameter)-(distal diameter)-(length)-w Note: All measurements are in millimeters. Red numbers indicate gap lengths. Gap lengths are approximate.
Proximal 4 Tapered Components (continued) 0 0 20 0 7 0 0 0 2 0 0 0 0 2 2 0 0 4 0 0 4 Zenith Alpha Thoracic Prox. Tapered Comp. 4
Proximal 4 Tapered Components (continued) 40 40 42 42 0 0 0 7 0 2 5 0 0 0 0 0 0 Zenith Alpha Thoracic 0 0 0 0 Prox. Tapered Comp. 50
Proximal 4 Tapered Components (continued) 44 44 4 4 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 40 2 42 2 2 2 40 42 Zenith Alpha Thoracic Prox. Tapered Comp. 5
Distal Components Order Number Reference Part Number Aortic Vessel OD Distal Component Diameter Distal Component Introducer Sheath ID/OD Fr ()/ Zenith Alpha Thoracic Distal Components 2 Diameter G5 ZTA-D-2-0-W 24-25 2 0 (5.)/.0 0 Diameter G5 ZTA-D-0-0-W 2-27 0 0 (5.)/.0 2 Diameter G55 ZTA-D-2-0-W 2-2 2 0 (.0)/7. 4 Diameter G5 ZTA-D-4-2-W 0 4 2 (.0)/7. G52 ZTA-D-4-0-W 0 4 0 (.0)/7. Diameter G5 ZTA-D--2-W -2 2 (.0)/7. G54 ZTA-D--0-W -2 0 (.0)/7. Diameter G55 ZTA-D--7-W -4 7 (.0)/7. G5 ZTA-D--7-W -4 7 (.0)/7. 40 Diameter G5 ZTA-D-40-7-W 5-40 7 20 (.7)/7.7 42 Diameter G5400 ZTA-D-42-204-W 7-42 204 20 (.7)/7.7 44 Diameter G5402 ZTA-D-44-2-W 44 2 20 (.7)/7.7 4 Diameter G5404 ZTA-D-4-2-W 40-4 4 2 20 (.7)/7.7 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Introduction System for Distal Components 2-0 grafts: Fr (5. ) ID/.0 OD 2- grafts: Fr (.0 ) ID/7. OD 40-4 grafts: 20 Fr (.7 ) ID/7.7 OD 52 cm 5 cm
Distal Components 2, 0, 2 4, 4, 0 0 0 2 0 0 7 0 0 Zenith Alpha Thoracic Distal Components 5 ZDA-D-XX-YYY-W ZDA-D-(diameter)-(length)-W Note: All measurements are in millimeters. Red numbers indicate gap lengths. Gap lengths are approximate.
Distal Components (continued), 40 42 44, 4 2 7 204 2 2 2 2 Zenith Alpha Thoracic 2 2 2 Distal Components 54
Distal Extensions Order Number Reference Part Number Aortic Vessel OD Diameter Introducer Sheath ID/OD Fr ()/ Diameter G550 ZTA-DE--04-W - 04 (5.)/.0 2 Diameter G55 ZTA-DE-2-04-W -2 2 04 (5.)/.0 0 Diameter G555 ZTA-DE-0-0-W 2-27 0 0 (5.)/.0 4 Diameter G55 ZTA-DE-4-2-W 0 4 2 (.0)/7. Diameter G552 ZTA-DE---W -4 (.0)/7. 42 Diameter G4 ZTA-DE-42-4-W 7-42 4 20 (.7)/7.7 4 Diameter G027 ZTA-DE-4-7-W 40-42 4 7 20 (.7)/7.7 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Introduction System for Distal Extensions -0 grafts: Fr (5. ) ID/.0 OD 4- grafts: Fr (.0 ) ID/7. OD 42-4 grafts: 20 Fr (.7 ) ID/7.7 OD Zenith Alpha Thoracic cm 5 cm Distal Extensions 55
Distal Extensions, 2 0 4 7 7 7 04 0 2 7 42 4 Zenith Alpha Thoracic 0 0 0 4 2 2 2 7 Distal Extensions 5 ZTA-DE-XX-YYY-W ZTA-DE-(diameter)-(length)-W Note: All measurements are in millimeters. Red numbers indicate gap lengths. Gap lengths are approximate.
Deployment Overview 2 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,.05, 20 or 00 cm double-curved Lunderquist wire guide up to the level of the aortic arch and remove the pigtail. POSITION THE PROXIMAL COMPONENT Introduce the flushed, hydrated introduction system for the proximal component over the extra-stiff double-curved 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. 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 5 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 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. REMOVE THE INTRODUCER SYSTEM FOR THE PROXIMAL COMPONENT Remove the introduction system entirely, leaving the wire guide positioned in the graft. Zenith Alpha Thoracic POSITION THE DISTAL COMPONENT Introduce the flushed, hydrated introduction system until the desired graft position has been achieved. Ensure that there is a minimum overlap of stents. 7 UNSHEATHE THE DISTAL COMPONENT Stabilize the gray positioner and withdraw the sheath until the Captor sleeve docks with the telescoping black gripper. Deployment 57
Deployment Overview* (continued) RELEASE THE DISTAL COMPONENT Use the -2- deployment sequence.. 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 until a stop is felt. 2. Turn the gray safety-lock knob indicated by label 2 on the black telescoping 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 telescoping 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 will turn green).. Turn the blue rotating handle in the direction of the arrow (label ) until a stop is felt and the proximal end of the graft opens. Zenith Alpha Thoracic 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. Deployment 5 * 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.
Precise placement and controlled delivery.
Indications for Use proximal neck diameter 24- great er proximal neck length 25 le sser distal neck diameter 24- distal neck length 25 Zenith TX2 TAA Indications 0 Indications for Use Aortic Fixation Site Diameter Angulation/ Curvature Access Introducer Diameters Contraindications The Zenith TX2 TAA Endovascular Graft with Pro-Form and the Z-Trak Plus Introduction System is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair including: Adequate iliac/femoral access compatible with the required introduction systems Nonaneurysmal aortic segments (fixation sites) proximal and distal to the aneurysm or ulcer: with a length of at least 25 with a diameter measured outer wall to outer wall of no greater than and no less than 24, and with an angle less than 45 degrees. Nonaneurysmal aortic necks proximal and distal to the aneurysm with a length 25 24 (measured outer wall to outer wall) A radius of curvature > 5 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 2 4 grafts: ID 20 Fr (.7 ) OD 7.7 42 grafts: ID Fr (7. ) OD.5 Patients with known sensitivities or allergies to stainless steel, polyester, solder (tin, silver), polypropylene, nitinol, or gold Patients with a systemic infection who may be at increased risk of endovascular stent infection
Proximal Components Order Number Reference Part Number Component Type Aortic Vessel OD Diameter Introducer Sheath ID/OD Fr ()/ 2 Diameter G54 ZTEG-2P-2-20-PF-US 2P 24 2 20 20 (.7)/7.7 G54 ZTEG-2P-2-0-PF-US 2P 24 2 0 20 (.7)/7.7 G5420 ZTEG-2P-2-200-PF-US 2P 24 2 200 20 (.7)/7.7 0 Diameter G542 ZTEG-2P-0-20-PF-US 2P 25-27 0 20 20 (.7)/7.7 G54 ZTEG-2P-0-0-PF-US 2P 25-27 0 0 20 (.7)/7.7 G542 ZTEG-2P-0-200-PF-US 2P 25-27 0 200 20 (.7)/7.7 2 Diameter G5424 ZTEG-2P-2-20-PF-US 2P 2-2 2 20 20 (.7)/7.7 G5425 ZTEG-2P-2-0-PF-US 2P 2-2 2 0 20 (.7)/7.7 G542 ZTEG-2P-2-200-PF-US 2P 2-2 2 200 20 (.7)/7.7 4 Diameter G5427 ZTEG-2P-4-27-PF-US 2P 0 4 27 20 (.7)/7.7 G542 ZTEG-2P-4-52-PF-US 2P 0 4 52 20 (.7)/7.7 G542 ZTEG-2P-4-202-PF-US 2P 0 4 202 20 (.7)/7.7 Diameter G540 ZTEG-2P--27-PF-US 2P -2 27 (7.)/.5 G54 ZTEG-2P--52-PF-US 2P -2 52 (7.)/.5 G542 ZTEG-2P--202-PF-US 2P -2 202 (7.)/.5 Diameter G54 ZTEG-2P--27-PF-US 2P -4 27 (7.)/.5 G544 ZTEG-2P--52-PF-US 2P -4 52 (7.)/.5 G545 ZTEG-2P--202-PF-US 2P -4 202 (7.)/.5 40 Diameter G24 ZTEG-2P-40-0-PF-US 2P 5-40 0 (7.)/.5 G54 ZTEG-2P-40-5-PF-US 2P 5-40 5 (7.)/.5 G547 ZTEG-2P-40-2-PF-US 2P 5-40 2 (7.)/.5 G54 ZTEG-2P-40-2-PF-US 2P 5-40 2 (7.)/.5 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Zenith TX2 TAA Prox. Components
Proximal Components (Continued) Order Number Reference Part Number Component Type Aortic Vessel OD Diameter Introducer Sheath ID/OD Fr ()/ 42 Diameter G240 ZTEG-2P-42-0-PF-US 2P 7-42 0 (7.)/.5 G54 ZTEG-2P-42-5-PF-US 2P 7-42 5 (7.)/.5 G5440 ZTEG-2P-42-2-PF-US 2P 7-42 2 (7.)/.5 G544 ZTEG-2P-42-2-PF-US 2P 7-42 2 (7.)/.5 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Z-Trak Plus Introduction System for Proximal Components 2-4 grafts: 20 Fr (.7 ) ID/7.7 OD -42 grafts: Fr (7. ) ID/.5 OD Zenith TX2 TAA.5 cm 75 cm Prox. Components 2
Proximal Components 2, 0, 2 2, 0, 2 2, 0, 2 20 0 200 4,, 4,, 4,, 27 52 202 Zenith TX2 TAA Prox. Components ZTEG-2P-XX-YYY-PF-US ZTEG-2P-(diameter)-(length)-PF-US Note: All measurements are in millimeters. The black numbers on the illustrations indicate stent lengths. The red numbers indicate gap lengths. Gap lengths are approximate.
Proximal Components (Continued) 40, 42 40, 42 40, 42 0 0 0 0 0 5 0 0 2 0 0 0 0 0 0 40, 42 Zenith TX2 TAA Prox. Components 0 0 0 0 0 0 0 2 4
Proximal Tapered Components Order Number Reference Part Number Component Type Aortic Vessel OD Introducer Proximal Sheath Diameter ID/OD Fr ()/ 2 Diameter G5442 ZTEG-2PT-2-0-PF-US 2PT 2-2 2 0 20 (.7)/7.7 G544 ZTEG-2PT-2-200-PF-US 2PT 2-2 2 200 20 (.7)/7.7 4 Diameter G5444 ZTEG-2PT-4-57-PF-US 2PT 0 4 57 20 (.7)/7.7 G5445 ZTEG-2PT-4-7-PF-US 2PT 0 4 7 20 (.7)/7.7 Diameter G544 ZTEG-2PT--57-PF-US 2PT -2 57 (7.)/.5 G5447 ZTEG-2PT--7-PF-US 2PT -2 7 (7.)/.5 Diameter G544 ZTEG-2PT--52-PF-US 2PT -4 52 (7.)/.5 G544 ZTEG-2PT--202-PF-US 2PT -4 202 (7.)/.5 40 Diameter G5450 ZTEG-2PT-40-5-PF-US 2PT 5-40 5 (7.)/.5 G545 ZTEG-2PT-40-20-PF-US 2PT 5-40 20 (7.)/.5 42 Diameter G5452 ZTEG-2PT-42-5-PF-US 2PT 7-42 5 (7.)/.5 G545 ZTEG-2PT-42-20-PF-US 2PT 7-42 20 (7.)/.5 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Z-Trak Plus Introduction System for Proximal Tapered Components 2-4 grafts: 20 Fr (.7 ) ID/7.7 OD -42 grafts: Fr (7. ) ID/.5 OD Zenith TX2 TAA Prox. Tapered Comp..5 cm 75 cm 5
Proximal Tapered Components 2 2 4 2 0 200 0 57 Zenith TX2 TAA Prox. Tapered Comp. 2 4 7 2 57 7 0 2 ZTEG-2PT-XX-YYY-PF-US ZTEG-2PT-(proximal diameter)-(length)-pf-us Note: All measurements are in millimeters. The black numbers on the illustrations indicate stent lengths. The red numbers indicate gap lengths. Gap lengths are approximate.
Proximal Tapered Components (Continued) 40 4 52 202 0 0 0 5 4 40 42 42 0 0 0 20 0 0 0 5 0 0 0 20 Zenith TX2 TAA Prox. Tapered Comp. 7
Distal Components Order Number Reference Part Number Component Type Diameter Introducer Sheath ID/OD Fr ()/ Zenith TX2 TAA Distal Components 2 Diameter G5472 ZTEG-2D-2-7-PF-US 2D 2 7 20 (.7)/7.7 G547 ZTEG-2D-2-207-PF-US 2D 2 207 20 (.7)/7.7 0 Diameter G547 ZTEG-2D-0-7-PF-US 2D 0 7 20 (.7)/7.7 G5474 ZTEG-2D-0-207-PF-US 2D 0 207 20 (.7)/7.7 2 Diameter G547 ZTEG-2D-2-7-PF-US 2D 2 7 20 (.7)/7.7 G5477 ZTEG-2D-2-207-PF-US 2D 2 207 20 (.7)/7.7 4 Diameter G547 ZTEG-2D-4--PF-US 2D 4 20 (.7)/7.7 G547 ZTEG-2D-4--PF-US 2D 4 20 (.7)/7.7 Diameter G540 ZTEG-2D---PF-US 2D (7.)/.5 G54 ZTEG-2D---PF-US 2D (7.)/.5 Diameter G542 ZTEG-2D---PF-US 2D (7.)/.5 G54 ZTEG-2D---PF-US 2D (7.)/.5 40 Diameter G544 ZTEG-2D-40-4-PF-US 2D 40 4 (7.)/.5 G545 ZTEG-2D-40--PF-US 2D 40 (7.)/.5 42 Diameter G54 ZTEG-2D-42-4-PF-US 2D 42 4 (7.)/.5 G547 ZTEG-2D-42--PF-US 2D 42 (7.)/.5 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Z-Trak Plus Introduction System for Distal Components 2-4 grafts: 20 Fr (.7 ) ID/7.7 OD -42 grafts: Fr (7. ) ID/.5 OD.5 cm 75 cm
Distal Components 2, 0, 2 2, 0, 2 4,, 4 4 7 4 4,, 40, 42 40, 42 0 0 0 0 4 207 4 4 0 0 0 0 0 0 4 Zenith TX2 TAA Distal Components ZTEG-2D-XX-YYY-PF-US ZTEG-2D-(diameter)-(length)-PF-US Note: All measurements are in millimeters. The black numbers on the illustrations indicate stent lengths. The red numbers indicate gap lengths. Gap lengths are approximate.
Proximal Extensions Order Number Reference Part Number Component Type Diameter Introducer Sheath ID/OD Fr ()/ Zenith TX2 TAA 2 Diameter G5454 TBE-2-0-PF-US TBE 2 0 20 (.7)/7.7 0 Diameter G5455 TBE-0-0-PF-US TBE 0 0 20 (.7)/7.7 2 Diameter G545 TBE-2-0-PF-US TBE 2 0 20 (.7)/7.7 4 Diameter G5457 TBE-4-77-PF-US TBE 4 77 20 (.7)/7.7 Diameter G545 TBE--77-PF-US TBE 77 (7.)/.5 Diameter G545 TBE--77-PF-US TBE 77 (7.)/.5 40 Diameter G540 TBE-40--PF-US TBE 40 (7.)/.5 42 Diameter G54 TBE-42--PF-US TBE 42 (7.)/.5 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Proximal Extensions 70
Proximal Extensions 2, 0, 2 4,, 40, 42 0 77 0 0 Proximal Extensions Zenith TX2 TAA 7 TBE-XX-YY-PF-US TBE-(diameter)-(length)-PF-US Note: All measurements are in millimeters. The black numbers on the illustrations indicate stent lengths. The red numbers indicate gap lengths. Gap lengths are approximate.
Distal Extensions Order Number Reference Part Number Component Type Diameter Introducer Sheath ID/OD Fr ()/ Zenith TX2 TAA Distal Extensions 2 Diameter G542 ESBE-2-0-T-PF-US ESBE 2 0 20 (.7)/7.7 0 Diameter G54 ESBE-0-0-T-PF-US ESBE 0 0 20 (.7)/7.7 2 Diameter G544 ESBE-2-0-T-PF-US ESBE 2 0 20 (.7)/7.7 4 Diameter G545 ESBE-4-77-T-PF-US ESBE 4 77 20 (.7)/7.7 Diameter G54 ESBE--77-T-PF-US ESBE 77 (7.)/.5 Diameter G547 ESBE--77-T-PF-US ESBE 77 (7.)/.5 40 Diameter G54 ESBE-40--T-PF-US ESBE 40 (7.)/.5 42 Diameter G54 ESBE-42--T-PF-US ESBE 42 (7.)/.5 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Z-Trak Plus Introduction System for Distal and Proximal Extensions 2-4 grafts: 20 Fr (.7 ) ID/7.7 OD -42 grafts: Fr (7. ) ID/.5 OD.5 cm 75 cm 72
Distal Extensions 2, 0, 2 4,, 40, 42 0 77 0 0 Distal Extensions Zenith TX2 TAA 7 ESBE-XX-YY-T-PF-US ESBE-(diameter)-(length)-T-PF-US Note: All measurements are in millimeters. The black numbers on the illustrations indicate stent lengths. The red numbers indicate gap lengths. Gap lengths are approximate.
Deployment Overview* GENERAL CAUTIONS Exercise extreme caution when manipulating interventional and angiographic devices in the region of the barbs. Do not advance the wire guide or introduction system if resistance is felt. Exercise particular care in areas of stenosis, thrombus, calcification, or tortuosity. Unless medically indicated, do not cover arch or mesenteric arteries with the graft. If the left subclavian artery is to be covered, the clinician must be aware of the risk for compromised perfusion of cerebral, upper limb, and collateral spinal arteries. Use caution during manipulation of catheters, wires, and sheaths within the aneurysm, as thrombus dislodgment and embolization may occur. Do not attempt to resheathe the graft after partial or complete deployment. Avoid damaging the graft or disturbing graft positioning if reinstrumentation is necessary. Anatomy and graft position can change with sheath removal; constantly monitor graft position, using angiography as necessary. Zenith TX2 TAA 2 POSITION LUNDERQUIST EXTRA-STIFF DC WIRE GUIDE IN AORTIC ARCH Through the radiopaque banded pigtail flush catheter, replace the standard wire guide with a stiff.05 inch 00 cm Lunderquist Extra-Stiff DC wire guide. Advance the wire guide up to the level of the aortic arch and remove the pigtail flush catheter. POSITION PROXIMAL COMPONENT Introduce the introduction system for the proximal component over the Lunderquist Extra-Stiff DC wire guide and advance until the desired graft position is reached. Caution: To avoid twisting the graft, never rotate the introduction system. Do not advance the sheath while the graft is still within it; doing so may cause the barbs to perforate the sheath. Deployment 74 4 UNSHEATHE PROXIMAL COMPONENT While constantly monitoring graft position, withdraw the sheath until the graft is fully expanded. Continue sheath withdrawal until the valve assembly docks with the control handle. Caution: Barbs are now exposed; limited forward advancement is possible, but retracting the device may damage the aorta. RELEASE PROXIMAL COMPONENT TRIGGER WIRES Unscrew and remove the safety lock from the green trigger-wire release mechanism. Withdraw the trigger wire slowly until the proximal end of the graft opens. Withdraw the trigger wire completely in a continuous movement to release the distal attachment to the introduction system. Make sure that all trigger wires are removed prior to withdrawal of the introduction system. 5 REMOVE INTRODUCER SHEATH FOR PROXIMAL COMPONENT Remove the introduction system entirely, leaving the wire guide positioned in the graft.
Deployment Overview* (Continued) 7 POSITION DISTAL COMPONENT Introduce the introduction system for the distal component over the Lunderquist Extra-Stiff DC wire guide and advance until the desired position inside of the proximal component is reached. Advance the introduction system of the distal component until the collapsed stent graft inside is in its intended location, with a recoended -4 stent overlap (75-00 ) with the proximal component. Note: The stainless steel stent bodies are easily visualized under fluoroscopy. UNSHEATHE DISTAL COMPONENT While constantly monitoring graft position, withdraw the sheath until the graft is fully expanded. Continue sheath withdrawal until the valve assembly docks with the control handle. RELEASE DISTAL COMPONENT TRIGGER WIRES Using the -2- deployment sequence:. Unscrew and remove the trigger-wire safety lock, then withdraw and remove the white trigger-wire release mechanism labeled #. 2. Unscrew and remove the safety lock on the telescoping handle labeled #2. Stabilize the introduction system and slide the telescoping handle together with the gray tube and outer sheath in a distal direction until it locks into position with a click.. Unscrew and remove the safety lock from the green trigger-wire release mechanism labeled #. Withdraw these release wires in a continuous movement until the proximal end of the graft opens, continuing withdrawal until the graft is fully opened and released. OPTIONAL: MOLDING BALLOON Position molding balloon and, utilizing diluted contrast media (as directed by manufacturer), expand it in areas of the proximal covered stent, proximal component/ distal component overlap, and distal fixation site, starting proximally and working in a distal direction. Confirm complete deflation of balloon prior to repositioning. Warning: Do not inflate the balloon in aorta outside confines of the graft. Zenith TX2 TAA 0 PERFORM FINAL FLUSH AORTOGRAM Position angiographic pigtail flush catheter just above the level of the deployed endovascular graft and perform angiography to verify: Correct graft position Patency of arch vessels and celiac plexus There are no endoleaks or kinks Position of proximal and distal gold radiopaque markers Withdraw introducer sheath for distal component, catheters and wires. Repair vessels and close in standard surgical fashion. Warning: To avoid entangling any in situ catheters, rotate the introduction system during withdrawal. *This deployment overview is an outline highlighting the deployment process for the Zenith TX2 TAA Endovascular Graft. The Suggested Instructions for Use booklet should be consulted for a more thorough examination of the deployment protocol, indications, contraindications, warnings, and precautions. Deployment 75
Accessories for endovascular procedures Contact your local Cook Medical Aortic Intervention or Peripheral Intervention representative for a more comprehensive list of accessory products.
Percutaneous Entry Thinwall Needle One-Part Access Percutaneous Entry Thinwall Needle One-Part Order Number Reference Part Number Accepts Wire Guide Diameter inch Gage cm G00 SDN--7.0.05/.0 7 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. 7
Micropuncture Introducer Sets Order Number Reference Part Number Catheter OD Fr/cm Wire Guide Diameter/ inch/cm Stiffened Cannula Nitinol Wire Guide with Platinum Tip Needle Gage/ cm G4007 MPIS-50-0.0-SC-NT-SST 5/0.0/40 2/7.0 Inch Stainless Steel Wire Guide Standard Cannula G4 MPIS-50-U-SST 5/0.0/40 2/7 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Access Micropuncture Introducer Sets 7
Endovascular Dilator Sets Dilators Endovascular Dilator Sets Order Number Reference Part Number Accepts Wire Guide Diameter inch Fr cm Hydrophilic Coated G52 JCDS--EDS-HC.05 45 yes G524 JCDS--EDS-HC.05, 45 yes G525 JCDS-20-EDS-HC.05 20, 45 yes G52 JCDS-242-EDS-HC.05 24, 2 45 yes Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. 0
Performer Introducers Order Number Reference Part Number Introducer Fr* Accepts Wire Guide Diameter inch Wire Guide Tip Config. Sheath cm Dilator cm Standard With Wire Guide G077 RCF-.0-5-J.0.05 J 20 G077 RCF-.0--J.0.0 J 20 G0777 RCF-7.0-5-J 7.0.05 J 20 G07 RCF-7.0--J 7.0.0 J 20 G0740 RCF-.0--J.0.0 J 20 Standard Without Wire Guide G0742 RCFW-5.0-5.0.0-20 G07420 RCFW-.0-.0.0-20 G074 RCFW-7.0-7.0.0-20 G0742 RCFW-.0-.0.0-20 Standard With Radiopaque Band Without Wire Guide G07 RCFW-.0-5-RB.0.05-20 G0 RCFW-7.0-5-RB 7.0.05-20 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. *Determine the maximum diameter of the instrument or catheter that you are introducing in order to ensure its passage through the sheath. Introducers Performer Introducers
Flexor Ansel Guiding Sheaths with High-Flex Dilator Introducers Flexor Ansel Guiding Sheaths with High-Flex Dilator Order Number Reference Part Number Standard Without Wire Guide Introducer ID Fr/* Accepts Wire Guide Diameter inch cm Curve G52 KCFW-.0-5-55-RB-HFANL0-HC /2.2.05 55 straight G52 KCFW-.0-5-55-RB-HFANL-HC /2.2.05 55 multipurpose G5 KCFW-.0-5-70-RB-HFANL0-HC /2.2.05 70 straight G5 KCFW-.0-5-70-RB-HFANL-HC /2.2.05 70 multipurpose G404 KCFW-7.0-5-55-RB-HFANL-HC 7/2.54.05 55 multipurpose G4045 KCFW-.0-5-55-RB-HFANL-HC /2.7.05 55 multipurpose G47700 KCFW-0.0-5-45-RB-HFANL-HC 0/.4.05 45 multipurpose Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. *Determine the maximum diameter of the instrument or catheter that you are introducing in order to ensure its passage through the sheath. 2
Large Check-Flo Performer Introducers with Radiopaque Band Order Number Reference Part Number Introducer Fr* Accepts Wire Guide Diameter inch Sheath cm Dilator cm G0 RCFW-.0P--0-RB.0.0 0 42 G2702 RCFW-.0P--5-RB.0.0 5 47 G052 RCFW-.0P--70-RB.0.0 70 2 G72 RCFW-.0P--0-RB.0.0 0 42 G02 RCFW-.0P--40-RB.0.0 40 52 G27025 RCFW-.0P--5-RB.0.0 5 7 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. *Determine the maximum diameter of the instrument or catheter that you are introducing in order to ensure its passage through the sheath. Introducers Large Check-Flo Performer Introducers with Radiopaque Band
Check-Flo Extra-Large Introducers Introducers Check-Flo Extra-Large Introducers Order Number Reference Part Number Introducer Fr* Accepts Wire Guide Diameter inch Sheath cm Dilator cm G20 XVCFW-20.0-5-40 20.0.05 40 5 G24 XVCFW-20.0-5-5 20.0.05 5 G2 XVCFW-.0-5-25.0.05 25 4 G22 XVCFW-.0-5-5.0.05 5 G2 XVCFW-24.0-5-25 24.0.05 25 4 G2 XVCFW-24.0-5-5 24.0.05 5 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. *Determine the maximum diameter of the instrument or catheter that you are introducing in order to ensure its passage through the sheath. 4
CXI Support Catheters Order Number Reference Part Number Fr Accepts Wire Guide Diameter inch Sheath cm Tip Configuration With Tungsten Marker Bands G CXI-2.--5-P-NS-ANG 2..0 5 ANG G7 CXI-2.--5-P-NS-0 2..0 5 straight G50002 CXI-2.--0-P-NS-ANG 2..0 0 ANG G50004 CXI-2.--0-P-NS-0 2..0 0 straight G5000 CXI-2.--50-P-NS-ANG 2..0 50 ANG G5000 CXI-2.--50-P-NS-0 2..0 50 straight G52547 CXI-4.0-5-0-P-NS-DAV 4.0.05 0 DAV G5254 CXI-4.0-5-0-P-NS-0 4.0.05 0 straight G5254 CXI-4.0-5-5-P-NS-DAV 4.0.05 5 DAV G52542 CXI-4.0-5-5-P-NS-0 4.0.05 5 straight G52545 CXI-4.0-5-50-P-NS-DAV 4.0.05 50 DAV G52544 CXI-4.0-5-50-P-NS-0 4.0.05 50 straight Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Catheters CXI Support Catheters 5
CrossCath Support Catheters Catheters CrossCath Support Catheters Order Number Reference Part Number Proximal/ Distal Fr With Hydrophilic Coating on Distal 40 cm Accepts Wire Guide Diameter inch cm Tip Configuration G47 CXC.4-2.2--5-P-NS-0.4/2.2.0 5 straight G5575 CXC.4-2.2--0-P-NS-0.4/2.2.0 0 straight G55 CXC.4-2.2--5-P-NS-0.4/2.2.0 5 straight G5577 CXC.4-2.2--50-P-NS-0.4/2.2.0 50 straight G4 CXC4.-.7-5-5-P-NS-0 4./.7.05 5 straight With Hydrophilic Coating on Distal 0 cm G550 CXC4.-.7-5-0-P-NS-0 4./.7.05 0 straight G55 CXC4.-.7-5-5-P-NS-0 4./.7.05 5 straight G552 CXC4.-.7-5-50-P-NS-0 4./.7.05 50 straight Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details.
Slip-Cath Beacon Tip Hydrophilic Angiographic Catheters Order Number Reference Part Number Fr Accepts Wire Guide Diameter inch cm G2 SCBR5.0--00-P-NS-SIM2 5.0.0 00 G4 SCBR5.0--5-P-NS-C2 5.0.0 5 G5 SCBR5.0--5-P-NS-RIM 5.0.0 5 G SCBR5.0--00-P-NS-DAV 5.0.0 00 G2000 SCBR5.0--00-P-NS-SIM 5.0.0 00 G2007 SCBR5.0--00-P-NS-VERT 5.0.0 00 G200 SCBR5.0--5-P-NS-0 5.0.0 5 G25 SCBR5.0--5-P-NS-KMP 5.0.0 5 G20 SCBR5.0--5-P-NS-TC 5.0.0 5 G SCBR5.0--5-P-NS-TC-BNK 5.0.0 5 G4 SCBR5.0--0-P-NS-VS 5.0.0 0 G200 SCBR5.0--0-P-NS-C2 5.0.0 0 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Catheters Slip-Cath Beacon Tip Hydrophilic Angiographic Catheters 7
Aurous Centimeter Sizing Catheters Catheters Aurous Centimeter Sizing Catheters Order Number Pigtail Reference Part Number Fr Accepts Wire Guide Diameter inch cm Sideports Number of Bands/ Placement Interval cm G2 NR5.0-5-00-P-0S-PIG-CSC-20 5.05 00 0 20/ Straight G2 NR5.0-5-00-P-0S-0-CSC-20 5.05 00 0 20/ Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details.
Beacon Tip Seeking Catheters 2 VS 4 5 C (Curly Q) Order Number Reference Part Number Van Schie Beacon Tip Seeking Catheters Fr Accepts Wire Guide Diameter inch cm G75 HNBR5.0-5-5-P-NS-VANSCHIE 5.0.05 5 G74 HNBR5.0-5-5-P-NS-VANSCHIE2 5.0.05 5 G72 HNBR5.0-5-5-P-NS-VANSCHIE 5.0.05 5 G7 HNBR5.0-5-5-P-NS-VANSCHIE4 5.0.05 5 G7 HNBR5.0-5-5-P-NS-VANSCHIE5 5.0.05 5 G57 HNBR5.0-5-25-P-NS-VANSCHIE 5.0.05 25 G574 HNBR5.0-5-25-P-NS-VANSCHIE2 5.0.05 25 G575 HNBR5.0-5-25-P-NS-VANSCHIE 5.0.05 25 G57 HNBR5.0-5-25-P-NS-VANSCHIE4 5.0.05 25 G577 HNBR5.0-5-25-P-NS-VANSCHIE5 5.0.05 25 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Beacon Tip Seeking Catheters Order Number Reference Part Number Fr Accepts Wire Guide Diameter inch cm Tip Configuration Catheters Beacon Tip Torcon NB Advantage Angiographic Catheters G574 HNBR5.0-5-25-P-NS-VS 5.0.05 25 VS G70 HNBR5.0-5-25-P-NS-C-PS 5.0.05 25 C (Curly Q) Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details.
Catheters Beacon Tip Torcon NB Advantage Angiographic Catheters Beacon Tip Torcon NB Advantage Angiographic Catheters Order Number VERT C2 KMP Reference Part Number DAV TEGT C Fr Accepts Wire Guide Diameter inch cm Tip Configuration G04 HNBR5.0-5-00-P-NS-SIM2 5.0.05 00 SIM2 G0444 HNBR5.0-5-5-P-NS-RIM 5.0.05 5 RIM G0442 HNBR5.0-5-5-P-NS-C2 5.0.05 5 C2 G044 HNBR5.0-5-5-P-NS-C 5.0.05 5 C G047 HNBR5.0-5-00-P-NS-SIM 5.0.05 00 SIM G0 HNBR5.0-5-00-P-NS-DAV 5.0.05 00 DAV G05 HNBR5.0--00-P-NS-DAV 5.0.0 00 DAV G054 HNBR5.0--40-P-NS-KMP 5.0.0 40 KMP G77 HNBR5.0--5-P-NS-TEGT 5.0.0 5 TEGT G20 HNBR5.0--0-P-NS-VS 5.0.0 0 VS G4 HNBR5.0--00-P-NS-VERT 5.0.0 00 VERT Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. SIM SIM2 VS RIM 0
Tornado Platinum Embolization Coils Order Number Reference Part Number.05 Inch Extended Coil Diameter Recoended Catheter ID and End Hole Diameter inch Extended Embolus cm Coiled Embolus Tapering Diameter G04 MWCE-5-4/-TORNADO.05 2. 4- G045 MWCE-5-5/-TORNADO.05 4. 5 G04 MWCE-5-/-TORNADO.05 5. G04 MWCE-5-7/-TORNADO.05 7 G04 MWCE-5-/4-TORNADO.05 4 G042 MWCE-5-/5-TORNADO.05.2 5 G042 MWCE-5-0/4-TORNADO.05 2.5 0-4 G04 MWCE-5-0/5-TORNADO.05 2.5 0 5 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Embolization Tornado Platinum Embolization Coils
Nester Platinum Embolization Coils Embolization Nester Platinum Embolization Coils 2 Order Number Reference Part Number.05 Inch Extended Coil Diameter Recoended Catheter ID and End Hole Diameter inch Extended Embolus cm Coiled Embolus Approximate Diameter Configuration Loops G52742 MWCE-5-7-4-NESTER.05 7 4 5. G5274 MWCE-5-7--NESTER.05 7.7 G52744 MWCE-5-7--NESTER.05 7 2. G52745 MWCE-5-7-0-NESTER.05 7 0 2.2 G5274 MWCE-5-7-2-NESTER.05 7 2. G52747 MWCE-5-7--NESTER.05 7. G5274 MWCE-5-7--NESTER.05 7.4 G5274 MWCE-5-7--NESTER.05 7.2 G52750 MWCE-5-7-20-NESTER.05 7 20. G2 MWCE-5--4-NESTER.05 4. G24 MWCE-5---NESTER.05 7.4 G25 MWCE-5---NESTER.05 5. G2 MWCE-5--0-NESTER.05 0 4.5 G22 MWCE-5--2-NESTER.05 2.7 G5275 MWCE-5---NESTER.05.2 G52752 MWCE-5---NESTER.05 2. G5275 MWCE-5---NESTER.05 2.5 G52754 MWCE-5--20-NESTER.05 20 2.2 G52755 MWCE-5-20--NESTER.05 20.5 G5275 MWCE-5-20-20-NESTER.05 20 20.2 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details.
Coda Balloon Catheters Order Number Reference Part Number Catheter Fr/ cm Recoended Introducer Fr G02 CODA-2-.0-5-00-2.0/00 2 G0 CODA-2-.0-5-20-2.0/20 2 G277 CODA-2-0.0-5-0-4 0.0/0 Accepts Wire Guide Diameter inch Balloon Maximum Inflated Diameter Balloon Maximum Inflation Volume ml.05 2 0.05 2 0.05 4 0 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Balloons Coda Balloon Catheters
Indy OTW Vascular Retrievers Retrievers Indy OTW Vascular Retrievers Order Number Reference Part Number Sheath OD Fr Accepts Wire Guide Diameter inch Sheath cm Basket Diameter G55 INDY-.0-5-55-40.0.05 55 40 G5 INDY-.0-5-00-40.0.05 00 40 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. 4
Roadrunner UniGlide Hydrophilic Wire Guides Order Number Reference Part Number Standard Shaft Straight Tip Wire Guide Diameter inch Wire Guide cm Taper cm Floppy Tip cm G550 HPW-5-0.05 0 G0502 HPW-5-20.05 20 Standard Shaft Angled Tip G54 HPWA-5-0.05 0 G042 HPWA-5-20.05 20 Stiff Shaft Straight Tip G55 HPWS-5-0.05 0 20 G04 HPWS-5-20.05 20 20 Stiff Shaft Angled Tip G57 HPWAS-5-0.05 0 20 G050 HPWAS-5-20.05 20 20 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Wire Guides Roadrunner UniGlide Hydrophilic Wire Guides 5
Safe-T-J Rosen Catheter Exchange Wire Guides Wire Guides Safe-T-J Rosen Catheter Exchange Wire Guides Order Number Reference Part Number PTFE-Coated Stainless Steel Diameter inch cm Taper cm Floppy Tip cm Tip Curve Radius G024 THSCF-5-0-.5-ROSEN.05 0 4.5.5.5 G025 THSCF-5-20-.5-ROSEN.05 20 4.5.5.5 PTFE-Coated Stainless Steel With Heparin Coating G02 THSCF-5-0-.5-ROSEN-BH.05 0 4.5.5.5 G04 THSCF-5-20-.5-ROSEN-BH.05 20 4.5.5.5 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details.
Bentson Fixed Core Wire Guides Order Number Reference Part Number Diameter inch cm Flexible Tip cm Straight PTFE-Coated Stainless Steel With Heparin Coating Distal Floppy Segment cm G0 TSFB-5-0-BH.05 0 20 G002 TSFB-5-20-BH.05 20 20 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Wire Guides Bentson Fixed Core Wire Guides 7
Lunderquist Extra-Stiff Wire Guides Double Curved Extended Double Curved Straight Curved Wire Guides Lunderquist Extra-Stiff Wire Guides Order Reference Number Part Number Diameter inch cm Straight Exchange PTFE-Coated Stainless Steel Flexible Tip cm Tip Curve Radius Coil cm G5 TSMG-5-20-LES.05 20 4 straight 5 G4552 TSMG-5-00-LES.05 00 4 straight 5 Curved Exchange PTFE-Coated Stainless Steel G455 TSCMG-5-20-7-LES.05 20 4 7.5 5 G45407 TSCMG-5-00-7-LES.05 00 4 7.5 5 Order Reference Number Part Number Diameter inch cm Flexible Tip cm Double Curved Exchange PTFE-Coated Stainless Steel Primary/ Secondary Curve Radius Coil cm G4520 TSCMG-5-20-LESDC.05 20 4 75/5 5 G4540 TSCMG-5-00-LESDC.05 00 4 75/5 5 Extended Double Curved Exchange PTFE-Coated Stainless Steel G57 TSCMG-5-20-E-LESDC.05 20 4 55/5 5 G57 TSCMG-5-00-E-LESDC.05 00 4 55/5 5 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details.
Amplatz Support Wire Guides Order Reference Number Part Number Wire Guide Diameter inch Wire Guide cm Taper cm Amplatz Extra-Stiff Straight PTFE-Coated Stainless Steel Floppy Tip cm G2 THSF-5-0-AES-ST.05 0 7 G240 THSF-5-20-AES-ST.05 20 7 Amplatz Ultra-Stiff 2 Straight PTFE-Coated Stainless Steel G54 THSF-5-20-AUS2.05 20.5.5 J Curved PTFE-Coated Stainless Steel G2020 THSCF-5-20--AUS2.05 20.5.5 Some products or part numbers may not be available in all markets. Contact your local Cook representative or Customer Service for details. Wire Guides Amplatz Support Wire Guides