Talent® Abdominal Stent Graft

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