Indications The Talent Thoracic Stent Graft System is intended for the endovascular repair of fusiform aneurysms and saccular aneurysms/penetrating ulcers of the descending thoracic aorta in patients having appropriate anatomy, including: Iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories; Non-aneurysmal aortic diameter in the range of 18 42mm; and Non-aneurysmal aortic proximal and distal neck lengths 20mm Contraindications The Talent Thoracic 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 Read all instructions carefully. Failure to properly follow the instructions, warnings and precautions may lead to serious consequences or injury to the patient The Talent Thoracic Stent Graft System should only be used by physicians and teams trained in vascular interventional techniques, including training in the use of this device. Specific training expectations are described in the Instructions for Use. Consider having a vascular surgery team available during implantation or reintervention procedures in the event that conversion to open surgical repair is necessary. Do not attempt to use the Talent Thoracic Stent Graft with the Captivia Delivery System in patients unable to undergo the necessary preoperative and postoperative imaging and implantation studies as described in the Instructions for Use. The Talent Thoracic Stent Graft System is not recommended in patients who cannot tolerate contrast agents necessary for intra-operative and post-operative follow-up imaging. The Talent Thoracic Stent Graft System is not recommended in patients exceeding weight and/ or size limits which compromise or prevent the necessary imaging requirements as described in the Instructions for Use. Prior to the procedure, pre-operative planning for access and placement should be performed. See Instructions for Use for more detail. Key anatomic elements that may affect successful exclusion of the aneurysm include severe neck angulation, short aortic neck(s) and significant thrombus and/or calcium at the arterial implantation sites. In the presence of anatomical limitations, a longer neck length may be required to obtain adequate sealing and fixation. See Instructions for Use. The use of this device requires administration of radiographic agents. Patients with preexisting renal insufficiency may have an increased risk of renal failure postoperatively. The safety and effectiveness of this device in the treatment of dissections have not been established Inappropriate patient selection may contribute to poor device performance. The long-term safety and effectiveness of this implant have not been established. All patients with endovascular aneurysm repair must undergo periodic imaging to evaluate the stent graft and aneurysm size. Significant aneurysm enlargement (>5 mm), the appearance of a new References 1. Data on file, deployment accuracy test. Medtronic Vascular; Santa Rosa, CA; 2009. 2. Data on file, number of devices implanted at initial procedure test. Medtronic Vascular; Santa Rosa, CA; 2010 3. Summary of Safety and Effectiveness Data Talent Thoracic Stent Graft System. 4. Lin PH, El Sayed HF, Kougias P, et al. Endovascular repair of thoracic aortic disease: overview of current devices and clinical results. Vascular. 2007;15(4):179-190. 5. Cook and Gore IFUs. Crossing profile (OD) is lower than Gore TAG in all diameters, and lower than or the same as Cook Zenith TX2 in all diameters except for 34mm stent graft, where Medtronic Talent is 1F size larger than Cook Zenith TX2. Data on file. Medtronic Vascular; Santa Rosa, CA; 2008. 6. Medtronic Field Assurance Worldwide Complaints for Talent Thoracic on CoilTrac January 2002-April 15, 2008 inclusive. 7. Data on file, Circumferential compression test. Medtronic Vascular; Santa Rosa, CA; 2008 a. This study was conducted to evaluate various performance characteristics and product attributes of thoracic endovascular stent graft systems used to treat thoracic aortic lesions. Testing was conducted on 34 mm commercially available devices in an air chamber that maintained ambient temperatures at 37 ±2 C. www.medtronicendovascular.com/talentcaptivia Medtronic CardioVascular 3576 Unocal Place Santa Rosa, CA 95403 USA Tel: 707.525.0111 Product Services Support Center Tel: 800.961.9055 Fax: 800.929.2133 CardioVascular LifeLine Customer Support Tel: 877.526.7890 Tel: 763.526.7890 endoleak, or migration resulting in an inadequate seal zone should prompt further investigation and may indicate the need for additional intervention or surgical conversion. Intervention or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aneurysms and/or endoleak. An increase in aneurysm size and/or persistent endoleak may lead to aneurysm rupture. Failure to align the connecting bar with the outer bend of the target vessel may increase the likelihood of endoleaks post implantation. During general handling of the Captivia Delivery System, avoid bending or kinking the graft cover because it may cause the Talent Thoracic Stent Graft to prematurely and improperly deploy. The retrieval of the tip must be carefully monitored with fluoroscopic guidance to ensure that the tip does not cause the Talent Thoracic Stent Graft to be inadvertently pulled down. MRI Safety and Compatibility Non-clinical testing has demonstrated that the Talent Thoracic Stent Graft is MR Conditional. It can be scanned safely in both 1.5T and 3.0T MR systems under certain conditions as described in the product Instructions for Use. For additional information regarding MRI please refer to the product Instructions for Use. Adverse Events Potential adverse events include (not arranged in any particular order): Amputation, Aneurysm Enlargement, Balloon rupture, Breakage of the metal portion of the device, Cardiac Failure/Infarction, Conversion to open surgery, Death, Deployment difficulties, Edema, Endoleak, Erectile Dysfunction, Erosion with fistula or pseudoaneurysm, Failure to deploy, Gastrointestinal complications, including: adynamic ileus, bowel (ileus, transient ischemic, infarction, necrosis), Graft twisting and/or kinking, Hemorrhage/Bleeding, Inaccurate placement, Infection and fever, Insertion and removal difficulties, Intercostal pain, Neurological complications, including: change in mental status, spinal cord ischemia with paraplegia, paraparesis and/or paresthesia, Cerebral Vascular Accidents (CVA), Transient Ischemic Attacks (TIA), neuropathy, and blindness, Prosthetic thrombosis, Pulmonary complications, Renal failure, Rupture of graft material, Ruptured vessel/aneurysm, Stent graft migration, Vascular complications including: thrombosis, thromboembolism, occlusion (arterial and venous), vessel dissection or perforation, collateral vessel occlusion, vascular ischemia, tissue necrosis, Wound healing complications. 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. Here to deliver. F R O M P I P E L I N E T O P A T I E N T For distribution in the USA only. 2010 Medtronic, Inc. All Rights Reserved. Printed in the USA. Trademarks are property of their respective owners. UC201102756 EN Talent Captivia THORACIC STENT GRAFT WITH THE DELIVERY SYSTEM
ON YOUR MARK accuracy matters most in the thoracic aorta. TALENT CAPTIVIA zeroes in. 1 Tip capture for controlled deployment and precise placement Hydrophilic coating to facilitate stent graft delivery 2 Longer lengths for fewer passes up tight iliacs 3 MEDTRONIC ENDOVASCULAR Talent thoracic stent graft WITH THE Captivia Delivery System 4
TAKE YOUR AIM With an intuitive three-step deployment process, TALENT CAPTIVIA provides control for proximal stent graft placement. Easy, three-step process Tip Deployment Tip Capture Tip Release 1 / Deploy slowly for maximum control. 2 / Deploy quickly, if desired 3 / Turn and pull the handle in one easy motion to release the tip capture Hydrophilic coating to facilitate stent graft delivery 5 MEDTRONIC ENDOVASCULAR Talent thoracic stent graft WITH THE Captivia Delivery System 6
E X PA N D YOUR REACH TALENT CAPTIVIA enables you to treat more patients. 3 Widest range of diameters currently available Proximal five-peak bare spring allows for crossing the LCC or LSA without occluding blood flow 4 Tapered distal main 4 Distal bare spring option to avoid covering the celiac artery 5 Profile similar to or lower than any other thoracic device DIAMETER COMPARISON Graft Diamater 22 24 26 28 30 32 34 36 38 40 42 44 46 Medtronic Talent Captivia Gore TAG Cook Zenith TX2 CROSSING PROFILE (OUTER DIAMETER) Graft Diamater 22 24 26 28 30 32 34 36 38 40 42 44 46 Medtronic Talent Captivia 22F 22F 22F 22F 22F 22F 24F 24F 24F 24F 25F 25F 25F Gore TAG 23F 23F 25F 25F 25F 27F 27F 27F 27F Cook Zenith TX2 23F 23F 23F 23F 25F 25F 25F 25F 7 MEDTRONIC ENDOVASCULAR Talent thoracic stent graft WITH THE Captivia Delivery System 8
E X P E C T YOUR SUCCESS Backed by a decade of global experience and clinically proven to excel across a diverse range of cases, Medtronic Endovascular earns your confidence with its experience in the thoracic aorta. No reported collapses in more than 20,000 implants worldwide within first six years 6 7 High radial force proven in competitive bench testing Courtesy of Rodney White, MD, Associate Chairman, Division of Vascular Surgery, Harbor UCLA Medical Center Stent Graft Radial Force Comparison Medtronic Talent Gore TAG Cook Zenith TX2 0.05.1.15 Increasing mean LBF Proximal sealing zone Distal sealing zone Body spring 9 MEDTRONIC ENDOVASCULAR Talent thoracic stent graft WITH THE Captivia Delivery System 10
Product Catalog PROXIMAL EXTENSIONS (a.k.a. CFN or REF) Proximal Aortic Distal Aortic ) Stent Graft Covered Length TAXF2626W50CP 26 26 50 22 TAXF2828W49CP 28 28 49 22 TAXF3030W48CP 30 30 48 22 TAXF3232W48CP 32 32 48 22 30 46mm 22 46mm 22 46mm PROXIMAL MAIN (a.k.a. CFN or REF)) Proximal Aortic Distal Aortic Stent Graft Covered Length TB2222C116CP 22 22 116 22 TF2424C116CP 24 24 116 22 TF2626C116CP 26 26 116 22 TAXF3434W48CP 34 34 48 24 TAXF3636W46CP 36 36 46 24 TAXF3838W46CP 38 38 46 24 TAXF4040W46CP 40 40 46 24 TAXF4242W54CP 42 42 54 25 TAXF4444W54CP 44 44 54 25 TAXF4646W52CP 46 46 52 25 component placement guide 112 200 mm 26 46mm TF2828C116CP 28 28 116 22 TF3030C115CP 30 30 115 22 TF3232C115CP 32 32 115 22 TF3434C115CP 34 34 115 24 TF3636C114CP 36 36 114 24 TF3838C114CP 38 38 114 24 TF4040C114CP 40 40 114 24 TF4242C113CP 42 42 113 25 TF4444C113CP 44 44 113 25 TF4646C112CP 46 46 112 25 TB2222C161CP 22 22 161 22 TF2424C161CP 24 24 161 22 TF2626C161CP 26 26 161 22 TF2828C161CP 28 28 161 22 TF3030C160CP 30 30 160 22 TF3232C160CP 32 32 160 22 TF3434C160CP 34 34 160 24 DISTAL MAIN (a.k.a. CFN or REF) Proximal Aortic Distal Aortic Stent Graft Covered Length TW2622C114CP 26 22 114 22 TW2824C113CP 28 24 113 22 TW3026C113CP 30 26 113 22 TW3228C113CP 32 28 113 22 TW3430C113CP 34 30 113 24 TW3632C112CP 36 32 112 24 TW3834C112CP 38 34 112 24 TW4036C112CP 40 36 112 24 TW4238C111CP 42 38 111 25 TW4440C111CP 44 40 111 25 TW4642C110CP 46 42 110 25 TW4644C110CP 46 44 110 25 TF3636C159CP 36 36 159 24 TF3838C159CP 38 38 159 24 TF4040C159CP 40 40 159 24 DISTAL EXTENSIONS 22 44mm TF4242C158CP 42 42 158 25 TF4444C158CP 44 44 158 25 TF4646C157CP 46 46 157 25 TF3030C200CP 30 30 200 22 TF3232C200CP 32 32 200 22 TF3434C200CP 34 34 200 24 TF3636C199CP 36 36 199 24 TF3838C199CP 38 38 199 24 TF4040C199CP 40 40 199 24 TF4242C198CP 42 42 198 25 TF4444C198CP 44 44 198 25 TF4646C197CP 46 46 197 25 LONGER LENGTHS (a.k.a. CFN or REF) Proximal Aortic Distal Aortic ) Stent Graft Covered Length TAXW2626B50CP 26 26 50 22 TAXW2828B49CP 28 28 49 22 TAXW3030B48CP 30 30 48 22 TAXW3232B48CP 32 32 48 22 TAXW3434B48CP 34 34 48 24 TAXW3636B46CP 36 36 46 24 TAXW3838B46CP 38 38 46 24 TAXW4040B46CP 40 40 46 24 TAXW4242B54CP 42 42 54 25 TAXW4444B54CP 44 44 54 25 TAXW4646B52CP 46 46 52 25 11 MEDTRONIC ENDOVASCULAR Talent thoracic stent graft WITH THE Captivia Delivery System 12