Talent® Abdominal Stent Graft

Talent® Abdominal Stent Graftwith THE Xcelerant® Hydro Delivery SystemExpanding the Indications for EVAR

Treat More PatientsShort Necks• The Talent® Abdominal Stent Graft is the only FDA-approveddevice for proximal aortic neck length as short as 10 mmAngled Necks• Approved for aortic neck angulation up to 60 degrees• Designed with approximately 15 mm suprarenal stentlength for conformability to angulated anatomyLarge Necks• Approved to treat up to 32 mm diameter necks• Available in stent graft sizes from 22 to 36 mmWide Range of Sizes• Most extensive offering of main bodies and extensions on the market – over 1,150 combinations• Tapered and flared iliac limb sizes from 8 to 24 mm• Full spectrum of sizes available up to 36 mm, including a 34 mm deviceSized to Fit Each Patient• Detailed sizing guidelines can be found in the IFU including vessel sizes treated, indications for use,crossing profile, and more• Risks associated with improper sizing include kinking, migration, aneurysm enlargement, and lossof tissue ingrowthA Comparison of Proximal Device DiametersMedtronic Talent®Cook Zenith®Gore Excluder®Endologix Powerlink®22 24 26 28 30 32 34 3622 24 26 28 30 32 3622 24 26 28.5 3125 28Size (mm)

Excellent Patient OutcomesOver 12 Years of Worldwide Experience 1• More than 50,000 patients treated worldwideExcellent Clinical ResultsU.S. PMA Pivotal Clinical Data at 1 Year 6Freedom from Aneurysm-Related Mortality 97.9%Freedom from Rupture 100%Freedom from Conversion 100%Migration 0.8%Stent Graft Patency 100%U.S. Clinical Data at 5 Years 2Freedom from Aneurysm-Related Mortality 96.5%Freedom from Rupture 98.2%Freedom from Conversion 99.1%Migration 2.3%Limb Thrombosis 0%Limb Kinking 0%Rate of Secondary Procedures 0%Gastrointestinal Events 3.2%Hematogenic Bleeding 1.1%Stroke 1.1%The long-term performance of endovascular grafts has not yet been established. All patientsshould be advised that endovascular treatment requires lifelong, regular follow-up to assesstheir health and the performance of their endovascular graft.

Multiple Options for Unique Patient CustomizationAortic Extension22-36 mmBifurcated Graft~15 mm22-36 mm~15 mmAlign radiopaque markers formaximum extension26-30 mm~15 mm50 mmRadiopaque markersFlow divider14 mm30 mmAlign radiopaquemarkers to ensure30 mm overlapContralateralLimb14 mm14 mm15 mmIliac ExtensionConnecting bar10-22 mm30 mmAlign radiopaque markersto ensure 30 mmminimum overlap12-20 mm8-24 mm8-24 mm

Talent® Converterwith the xcelerant® hydro delivery systemTalent® Occluderwith the OCCLUDER delivery system22-36 mm8-24 mm~15 mm31-35 mmConnectingBar~125 mmRadiopaque markers16 mmF–FreeFloB–Bare springW–Open webC–Closed webChoose from various lengths, diameters, variable tapering andflaring, and an array of proximal and distal designs to create astent graft to your specifications.

Designed to DeliverLow Profile• Xcelerant® Hydro Delivery System facilitates stent graft treatment in patients with difficult access 3• System does not require a sheath, unlike Gore and Cook systemsA Comparison of Delivery System Profiles 4,5Talent XcelerantHydro Delivery System 6Artery Diameter: 7.3 mmGore Excluder System 7Artery Diameter: 7.3 mmCook Zenith System 8Artery Diameter: 8 mmDelivery SystemDiameter: 22FSheath Diameter: 22FSheath Diameter: 24FInnerDiameter:N/AInnerDiameter:(18F)InnerDiameter:(20F)Sheath Not RequiredSheath RequiredSheath RequiredHydrophilic Coating• Designed to aid navigation through tight 6 and tortuous 3 iliacsMinimum 32 cm with hydrophiliccoating for better deliverabilityNo coating for cathetermanipulation at least 15 cmEasy and Accurate Three-Step DeploymentProper device sizing and the Xcelerant Hydro Delivery System’s hydrophilic coating can help minimizethe risk of adverse events including iliac vessel rupture, perforation, or other deployment difficulties.123

Talent® Abdominal Stent Graftwith The Xcelerant® Hydro Delivery SystemFor Medtronic ordering information contact your Medtronic Field Representative.BIFURCATEDProduct CodeCONTRALATERAL LIMBSProduct CodeProximalDiameter(mm)ProximalDiameter(mm)DistalDiameter(mm)DistalDiameter(mm)Graft CoveredLength(mm)Graft CoveredLength(mm)Stent GraftTotal Length(mm)Stent GraftTotal Length(mm)CatheterDiameter(F)AB2212C140XH 22 12 140 155 22AB2212C155XH 22 12 155 170 22AB2214C140XH 22 14 140 155 22AB2214C155XH 22 14 155 170 22AF2412C140XH 24 12 140 155 22AF2412C170XH 24 12 170 185 22AF2414C140XH 24 14 140 155 22AF2414C170XH 24 14 170 185 22AF2612C140XH 26 12 140 155 22AF2612C170XH 26 12 170 185 22AF2614C140XH 26 14 140 155 22AF2614C170XH 26 14 170 185 22AF2616C140XH 26 16 140 155 22AF2616C170XH 26 16 170 185 22AF2618C140XH 26 18 140 155 22AF2618C170XH 26 18 170 185 22AF2814C140XH 28 14 140 155 22AF2814C170XH 28 14 170 185 22AF2816C140XH 28 16 140 155 22AF2816C170XH 28 16 170 185 22AF2818C140XH 28 18 140 155 22AF2818C170XH 28 18 170 185 22AF2820C140XH 28 20 140 155 22AF2820C170XH 28 20 170 185 22AF3014C140XH 30 14 140 155 24AF3014C170XH 30 14 170 185 24AF3016C140XH 30 16 140 155 24AF3016C170XH 30 16 170 185 24AF3018C140XH 30 18 140 155 24AF3018C170XH 30 18 170 185 24AF3020C140XH 30 20 140 155 24AF3020C170XH 30 20 170 185 24AF3214C155XH 32 14 155 170 24AF3214C170XH 32 14 170 185 24AF3216C155XH 32 16 155 170 24AF3216C170XH 32 16 170 185 24AF3218C155XH 32 18 155 170 24AF3218C170XH 32 18 170 185 24AF3220C155XH 32 20 155 170 24AF3220C170XH 32 20 170 185 24AF3416C155XH 34 16 155 170 24AF3416C170XH 34 16 170 185 24AF3418C155XH 34 18 155 170 24AF3418C170XH 34 18 170 185 24AF3420C155XH 34 20 155 170 24AF3420C170XH 34 20 170 185 24AF3618C155XH 36 18 155 170 24AF3618C170XH 36 18 170 185 24AF3620C155XH 36 20 155 170 24AF3620C170XH 36 20 170 185 24CatheterDiameter(F)IW1408C105XH 14 8 105 120 18IW1410C105XH 14 10 105 120 18IW1412C75XH 14 12 75 90 18IW1412C90XH 14 12 90 105 18IW1412C105XH 14 12 105 120 18IW1414C75XH 14 14 75 90 18IW1414C90XH 14 14 90 105 18IW1412C105XH 14 14 105 120 18IW1416C75XH 14 16 75 90 18IW1416C90XH 14 16 90 105 18IW1416C105XH 14 16 105 120 18IW1418C75XH 14 18 75 90 18IW1418C90XH 14 18 90 105 18IW1418C105XH 14 18 105 120 18IW1420C75XH 14 20 75 90 18IW1420C90XH 14 20 90 105 18IW1420C105XH 14 20 105 120 18IW1422C75XH 14 22 75 90 20IW1422C90XH 14 22 90 105 20IW1422C105XH 14 22 105 120 20IW1424C75XH 14 24 75 90 20IW1424C90XH 14 24 90 105 20IW1424C105XH 14 24 105 120 20AORTIC EXTENSIONSProximalProduct CodeDiameter(mm)DistalDiameter(mm)Graft CoveredLength(mm)Stent GraftTotal Length(mm)CatheterDiameter(F)AXB2222W30XH 22 22 30 60 20AXF2424W30XH 24 24 30 60 20AXF2626W30XH 26 26 30 60 20AXF2828W29XH 28 28 29 60 20AXF3030W28XH 30 30 28 60 22AXF3232W28XH 32 32 28 60 22AXF3434W28XH 34 34 28 60 22AXF3636W26XH 36 36 26 60 22ILIAC EXTENSIONSProduct CodeProximalDiameter(mm)DistalDiameter(mm)Graft CoveredLength(mm)Stent GraftTotal Length(mm)CatheterDiameter(F)IXW1010C81XH 10 10 81 95 18IXW1208C75XH 12 8 75 90 18IXW1212C81XH 12 12 81 95 18IXW1410C75XH 14 10 75 90 18IXW1414C80XH 14 14 80 95 18IXW1612C75XH 16 12 75 90 18IXW1616C80XH 16 16 80 95 18IXW1812C140XH 18 12 140 155 20IXW1812C80XH 18 12 80 95 18IXW1814C140XH 18 14 140 155 20IXW1814C75XH 18 14 75 90 18IXW1816C140XH 18 16 140 155 20IXW1816C80XH 18 16 80 95 18IXW1818C140XH 18 18 140 155 20IXW1818C80XH 18 18 80 95 18IXW1820C80XH 18 20 80 95 18IXW1822C80XH 18 22 80 95 20IXW1824C80XH 18 24 80 95 20IXW2016C74XH 20 16 74 90 18IXW2020C79XH 20 20 79 95 18IXW2218C74XH 22 18 74 90 20IXW2222C79XH 22 22 79 95 20Talent® Converterwith The Xcelerant® Hydro Delivery SystemProduct CodeProximalDiameter(mm)DistalDiameter(mm)Graft CoveredLength(mm)Stent GraftTotal Length(mm)CatheterDiameter(F)CVB2216C126XH 22 16 126 140 22CVF2416C126XH 24 16 126 140 22CVF2616C126XH 26 16 126 140 22CVF2816C126XH 28 16 126 140 22CVF3016C125XH 30 16 125 140 24CVF3216C125XH 32 16 125 140 24CVF3416C125XH 34 16 125 140 24CVF3616C124XH 36 16 124 140 24Talent® Occluderwith The occluder Delivery SystemProduct CodeProximalDiameter(mm)Stent GraftTotal Length(mm)CatheterDiameter(F)OCL08US 8 31 17.5OCL10US 10 31 17.5OCL12US 12 31 17.5OCL14US 14 33 17.5OCL16US 16 33 17.5OCL18US 18 33 17.5OCL20US 20 35 17.5OCL22US 22 35 17.5OCL24US 24 35 17.5

The Talent® Abdominal Stent GraftIndicationsThe Talent® Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aorticaneurysms with or without iliac involvement having:• Iliac/femoral access vessel morphology that is compatible with vascular access techniques,devices, and/or accessories;• A proximal aortic neck length of ≥10 mm;• Proximal aortic neck angulation ≤ 60°;• Distal iliac artery fixation length of ≥ 15 mm;• An aortic neck diameter of 18–32 mm and iliac artery diameters of 8–22 mm; and• Vessel morphology suitable for endovascular repair.ContraindicationsThe Talent Abdominal Stent Graft is contraindicated in:• Patients who have a condition that threatens to infect the graft.• Patients with sensitivities or allergies to the device materials.Warnings and Precautions• The long-term performance of endovascular grafts has not yet been established. All patientsshould be advised that endovascular treatment requires lifelong, regular follow-up to assess theirhealth and the performance of their endovascular graft. Patients with specific clinical findings (e.g.,endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft)should receive enhanced follow-up. Specific follow-up guidelines are described in the Instructionsfor Use.• Patients experiencing reduced blood flow through the graft limb, aneurysm expansion, andpersistent endoleaks may be required to undergo secondary interventions or surgical procedures.• The Talent Abdominal Stent Graft is not recommended in patients unable to undergo or who willnot be compliant with the necessary preoperative and postoperative imaging and implantationstudies as described in the Instructions for Use.• Renal complications may occur: 1)From an excess use of contrast agents. 2)As a result of embolior a misplaced stent graft. The radiopaque marker along the edge of the stent graft should bealigned immediately below the lower-most renal arterial origin.• Studies indicate that the danger of micro-embolization increases with increased duration of theprocedure.• The safety and effectiveness of the Talent Abdominal Stent Graft System has not been evaluatedin some patient populations. Please refer to the product Instructions for Use for details.MRI Safety and Compatibility: Non-clinical testing has demonstrated that the Talent AbdominalStent Graft is MR Conditional. It can be scanned safely in both 1.5T & 3.0T MR systems under certainconditions as described in the product Instructions for Use. For additional information regardingMRI please refer to the product Instructions for Use.Adverse EventsPotential adverse events include (not arranged in any particular order): Aneurysm enlargement;aneurysm rupture and death; aortic damage (including perforation, dissection, bleeding, ruptureand death); arterial or venous thrombosis and/or pseudoaneurysm; bleeding, hematoma orcoagulopathy; cardiac complications; claudication; death; embolization (micro and macro)with transient or permanent ischemia or infarction; endoleak; fever and localized inflammation;occlusion of device or native vessel; pulmonary/respiratory complications and subsequentattendant problems; renal complications and subsequent attendant problems; surgical conversionto open repair; vascular access site complications ;vascular spasm or vascular trauma; vesseldamage; wound complications and subsequent attendant problems; stent graft complications:improper component placement, incomplete component deployment, component migration,suture break, occlusion, infection, stent fracture, graft twisting and/or kinking, insertion andremoval difficulties, graft material wear, dilatation, erosion, puncture, and perigraft flow.Please reference product Instructions for Use for more information regarding indications, warnings,precautions, contraindications and adverse events.CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.The Talent® Converter Stent Graft with Xcelerant® Hydro Delivery SystemIndicationsThe Talent® Converter Stent Graft with Xcelerant® Hydro Delivery System is indicated for secondaryendovascular intervention in patients having received prior endovascular repair of infrarenalabdominal aortic or aortoiliac aneurysms using the Talent or AneuRx Bifurcated Stent Grafts,in which there is inadequate proximal fixation, seal, overlapping of modular components orunattainable contralateral limb cannulation.The anatomical considerations are as follows:• Iliac/femoral access vessel morphology that is compatible with vascular access techniques,devices, and/or accessories• Adequate proximal fixation site:• with a length from the lowest renal artery to the proximal fabric edge of the previously placedbifurcated stent graft between 0 mm and 34 mm• with a vessel diameter of ≥18 mm and ≤ 32 mm• proximal aortic neck angulation ≤ 60° relative to the long axis of the aneurysm• Adequate distal fixation site:• For the Converter used without an iliac extension the landing zone of the distal fixation sitewithin the bifurcated graft segment of ≤16mm in diameter and at least 30 mm in overlap length(between the bifurcation and distal end of the Talent Converter)• For the Converter used in combination with an iliac extension, distal fixation site within the iliacartery greater than 15 mm in length and 8 mm to 22 mm in diameterContraindicationsThe Talent Converter Stent Graft is contraindicated in:• Patients who have a condition that threatens to infect the graft• Patients with sensitivities or allergies to the device materials• Patients with a pre-existing iliac extension with a distal diameter of ≤ 8 mm.Warnings and Precautions• The long-term performance of endovascular grafts with secondary endovascular interventionusing additional components has not yet been established. All patients receiving the TalentConverter should receive enhanced follow-up. Specific follow-up guidelines are described in theInstructions for Use.• The Talent Converter is not intended as a stand alone device to repair abdominal aneurysms.Notes and References:1. Talent on all delivery systems. 2. Data from Medtronic Clinical 5-year update. 3. Difficult access is definedas tortuous iliac anatomies. Bench testing data on file. 4. Crossing profile similar to or lower than closestcompetitors. 5. Competitive devices were tested with Cook Introducer sheaths, 18F with the Gore Excluder,and 20F with the Cook Zenith. Test units were all 28 mm bifurcated stent grafts. 6. Talent Abdominal StentGraft System Instructions For Use. 7. Gore Excluder® AAA Endoprosthesis Instructions for Use. 8. Zenith® AAAEndovascular Graft Instructions For Use.Talent® Converter Stent Graft continued -Rather, the Talent Converter is used for secondary repair of previously placed Talent or AneuRxBifurcated Stent Grafts or in cases where contralateral gate cannulation is unattainable at the timeof index procedure.• Medtronic has conducted testing to evaluate mechanical interactions between the TalentConverter Stent Graft System and the pre-existing Talent or AneuRx Bifurcated Stent Graft. TheTalent Converter Stent Graft System has not been evaluated for use with any other commerciallyavailable bifurcated stent grafts.• Patients experiencing reduced blood flow through the graft limb, enlarging aneurysms andpersistent endoleaks may be required to undergo secondary interventions or surgical procedures.An increase in aneurysm size and/or persistent endoleak may lead to aneurysm rupture.• Renal complications may occur – 1) From an excess use of contrast agents 2) As a result of embolior a misplaced stent graft. The radiopaque marker along the edge of the stent graft should bealigned immediately below the lower-most renal arterial origin.• The danger of micro-embolization increases with increased duration of the procedure.MRI Safety and Compatibility: Non-clinical testing has demonstrated that the Talent ConverterStent Graft is MR Conditional. It can be scanned safely in both 1.5T & 3.0T MR systems under certainconditions as described in the product Instructions for Use. For additional information regardingMRI please refer to the product Instructions for Use.Potential Adverse EventsPotential adverse events include (not arranged in any particular order): Aneurysm enlargement;aneurysm rupture and death; aortic damage (including perforation, dissection, bleeding, ruptureand death); arterial or venous thrombosis and/or pseudoaneurysm; bleeding, hematomaor coagulopathy; cardiac complications and subsequent attendant problems; claudication;damage or dislodgement of pre-existing graft; death; embolization (micro and macro) withtransient or permanent ischemia or infarction; endoleak; fever and localized inflammation; fistula(e.g. arteriovenous, lymph fistula) occlusion of device or native vessel; pulmonary/respiratorycomplications; renal complications; surgical conversion to open repair; vascular access sitecomplications ;vascular spasm or vascular trauma; vessel damage; wound complications; stent graftcomplications: improper component placement, incomplete component deployment, componentmigration, suture break, occlusion, infection, stent fracture, graft twisting and/or kinking, insertionand removal difficulties, graft material wear, dilatation, erosion, puncture, and perigraft flow andcorrosion.Please reference product Instructions for Use for more information regarding indications, warnings,precautions, contraindications and adverse events.CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.The Talent® Occluder with Occluder Delivery SystemIndicationsThe Talent® Occluder with Occluder Delivery system is intended for endoluminal occlusion of thecommon iliac artery in order to prevent retrograde blood into the aneurysm sac when used inconjunction with a fem-fem bypass (for example, the Talent Occluder can be used in combinationwith the Talent Converter Stent Graft).The anatomical considerations are as follows:• Iliac/femoral access vessel morphology that is compatible with vascular access techniques and adelivery system profile of 17.5 French• Common iliac vessel diameters between 6 mm and 20 mmContraindicationsThe Talent Occluder is contraindicated in:• Patients who have a condition that threatens to infect the graft• Patients with sensitivities or allergies to the device materialsWarnings and Precautions• The long-term performance of the Talent Occluder has not yet been established. All patientsreceiving the Talent Occluder should receive enhanced follow-up. Specific follow-up guidelines aredescribed in the Instructions for Use.• Renal complications may occur: 1)From an excess use of contrast agents 2)As a result of emboli.• Studies indicate that the danger of micro-embolization increases with increased duration of theprocedure.• The safety and effectiveness of the Talent Occluder System has not been evaluated in somepatient populations. Please refer to the product Instructions for Use for details.MRI Safety and Compatibility: Non-clinical testing has demonstrated that the Talent Occluder isMR Conditional. It can be scanned safely in both 1.5T & 3.0T MR systems under certain conditionsas described in the product Instructions for Use. For additional information regarding MRI pleaserefer to the product Instructions for Use.Potential Adverse EventsPotential adverse events include (not arranged in any particular order): Aneurysm enlargement;aneurysm rupture and death; aortic damage (including perforation, dissection, bleeding, ruptureand death); arterial or venous thrombosis and/or pseudoaneurysm; bleeding, hematomaor coagulopathy; cardiac complications and subsequent attendant problems; claudication;dislodgement of pre-existing graft (for example, a Talent Converter);death; embolization (microand macro) with transient or permanent ischemia or infarction; endoleak; fever and localizedinflammation; pulmonary/respiratory complications; renal complications; surgical conversion toopen repair; vascular access site complications ;vascular spasm or vascular trauma; vessel damage;wound complications and subsequent attendant problems; stent graft complications: impropercomponent placement, incomplete component deployment, component migration, suture break,occlusion, infection, stent fracture, graft twisting and/or kinking, insertion and removal difficulties,graft material wear, dilatation, erosion, puncture, and perigraft flow.Please reference product Instructions for Use for more information regarding indications, warnings,precautions, contraindications and adverse events.CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.www.medtronic.comwww.talentstentgraft.comMedtronic Vascular3576 Unocal PlaceSanta Rosa, CA 95403USATel: 707.525.0111CardioVascular LifeLineCustomer SupportTel: 877.526.7890Tel: 763.526.7890Product ServicesTel: 888.283.7868Fax: 800.838.3103For distribution in the USA only. © 2010 Medtronic, Inc. All rights reserved. Printed in the USA. Trademarks are property of their respective owners. UC201002597aEN 05/10