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Talent Thoracic Stent Graft product brochure


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Talent Thoracic Stent Graft product brochure - 1

Talent Captivia DELIVERY SYSTEM 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 • ead all instructions carefully. Failure to properly follow the instructions, warnings and R precautions may lead to serious consequences or injury to the patient • he Talent Thoracic Stent Graft System should only be used by physicians and teams trained in T vascular interventional techniques, including training in the use of this device. Specific training expectations are described in the Instructions for Use. • onsider having a vascular surgery team available during implantation or reintervention C procedures in the event that conversion to open surgical repair is necessary. • o not attempt to use the Talent® Thoracic Stent Graft with the Captivia Delivery System D in patients unable to undergo the necessary preoperative and postoperative imaging and implantation studies as described in the Instructions for Use. • he Talent Thoracic Stent Graft System is not recommended in patients who cannot tolerate T contrast agents necessary for intra-operative and post-operative follow-up imaging. • he Talent Thoracic Stent Graft System is not recommended in patients exceeding weight and/ T or size limits which compromise or prevent the necessary imaging requirements as described in the Instructions for Use. • rior to the procedure, pre-operative planning for access and placement should be performed. P 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. • he use of this device requires administration of radiographic agents. Patients with preexisting T renal insufficiency may have an increased risk of renal failure postoperatively. • he safety and effectiveness of this device in the treatment of dissections have not been T established • Inappropriate patient selection may contribute to poor device performance. • he long-term safety and effectiveness of this implant have not been established. All patients T 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 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. 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. in 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. L 5. ook 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 C 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. his study was conducted to evaluate various performance characteristics and product attributes of thoracic endovascular stent graft systems used to treat T thoracic aortic lesions. Testing was conducted on 34 mm commercially available devices in an air chamber that maintained ambient temperatures at 37°±2°C. Product Services Support Center Tel: 800.961.9055 Fax: 800.929.2133 endoleak, or migration resulting in an inadequate seal zone should prompt further investigation and may indicate the need for additional intervention or surgical conversion. • ntervention or conversion to standard open surgical repair following initial I 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. • ailure to align the connecting bar with the outer bend of the target vessel may F increase the likelihood of endoleaks post implantation. • uring general handling of the Captivia Delivery System, avoid bending or kinking D the graft cover because it may cause the Talent® Thoracic Stent Graft to prematurely and improperly deploy. • he retrieval of the tip must be carefully monitored with fluoroscopic guidance T to ensure that the tip does not cause the Talent® Thoracic Stent Graft to be inadvertently pulled down. CardioVascular LifeLine Customer Support Tel: 877.526.7890 Tel: 763.526.7890 Talent Captivia WITH THE DELIVERY SYSTEM 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 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: • liac/femoral access vessel morphology that is compatible with vascular access techniques, I devices, and/or accessories; • Non-aneurysmal aortic diameter in the range of 18 – 42mm; and • Non-aneurysmal aortic proximal and distal neck lengths ≥ 20mm Medtronic CardioVascular 3576 Unocal Place Santa Rosa, CA 95403 USA Tel: 707.525.0111 Talent Captivia WITH THE DELIVERY SYSTEM Talent Captivia WITH THE DELIVERY SYSTEM WITH THE DELIVERY SYSTEM

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