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Valiant Thoracic Stent Graft product brochure
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Valiant Thoracic Stent Graft product brochure - 1

Indications The Valiant® Thoracic Stent Graft with the Captivia® Delivery 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: • IIiac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories; • Non-aneurysmal aortic diameter in the range of 18 – 42 mm; and • Non-aneurysmal aortic proximal and distal neck lengths ≥ 20 mm Contraindications The Valiant Thoracic Stent Graft with the Captivia Delivery System 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 safety and effectiveness of the Valiant Thoracic Stent Graft with the Captivia Delivery System has not been established. All patients should be advised that endovasculartreatment requires lifelong, regular follow-up to assess the integrity and performance of the implanted endovascular stent graft. Patients with specific clinical findings (for example, enlarging aneurysm, endoleaks, migration, or inadequate seal zone) should receive enhanced follow-up. Specific follow-up guidelines are described in the Instructions for Use. The Valiant Thoracic Stent Graft with the Captivia Delivery System is not recommended in patients who cannot undergo, or who will not be compliant with, the necessary preoperative and postoperative imaging and implantation procedures as described in the Instructions for Use. Strict adherence to the Valiant Thoracic Stent Graft sizing guidelines as described in the Instructions for Use is expected when selecting the device size. Sizing outside of this range can potentially result in endoleak, fracture, migration, infolding, or graft wear. The safety and effectiveness of the Valiant Thoracic Stent Graft with the Captivia Delivery System has not been evaluated in some patient populations. Please refer to the product Instructions for Use for details Adverse Events Potential adverse events include, but are not limited to access failure, adynamic ileus, allergic reaction (to contrast, antiplatelet therapy, stent graft material), amputation, anaesthetic complications, aneurysm expansion, aneurysm rupture, angina, arrhythmia, arterial stenosis, atelectasis, blindness, bowel ischemia, bowel necrosis, bowel obstruction, branch vessel occlusion, breakage of the metal portion of the device, buttock claudication, cardiac tamponade, catheter breakage, cerebrovascular accident (CVA)/stroke, change in mental status, coagulopathy, congestive heart failure, contrast toxicity, conversion to surgical repair, death, deployment difficulties/failures, dissection/perforation/ rupture of the aortic vessel and/or surrounding vasculature, embolism, endoleak(s), excessive or inappropriate radiation exposure, extrusion/erosion, failure to deliver stent graft, femoral neuropathy, fistula (including aortoenteric,arteriovenous, and lymph), Gastrointestinal bleeding/complications, genitourinary complications, hematoma, hemorrhage/bleeding, hypotension/hypertension, infection and/or fever, insertion and removal difficulties, intercostal pain, intramural hematoma, leg/foot edema, lymphocele, myocardial infarction, neuropathy, occlusion – venous or arterial, pain/reaction at catheter insertion site, paralysis, paraparesis, paraplegia, paresthesia, peripheral ischemia, peripheral nerve injury, pneumonia, post-implant syndrome, procedural/post-procedural bleeding, prosthesis dilatation/infection/rupture/thrombosis, pseudoaneurysms, pulmonary edema, pulmonary embolism, reaction to anaesthesia, renal failure, renal insufficiency, reoperation, respiratory depression/failure, sepsis, seroma, shock, spinal neurological deficit, stent graft migration/misplacement/occlusion/ twisting/kinking, transient ischemic attack (TIA), thrombosis, tissue necrosis, vascular ischemia, vascular trauma, wound dehiscence, wound healing complications, and/or wound infection. 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.com www.medtronicendovascular.com Medtronic Vascular, Inc. 3576 Unocal Place Santa Rosa, CA 95403 USA Product Services Support Center Tel: 888.283.7868 Fax: 800.838.3103 CardioVascular LifeLine Customer Support Tel: 877.526.7890 Tel: 763.526.7890 UC201202487a EN © Medtronic, Inc. 2012. All Rights Reserved. For distribution in the USA only. Non-clinical testing has demonstrated that the Valiant Thoracic Stent Graft is MR Conditional. It can be scanned safely in both 1.5 T & 3.0 T 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.

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Valiant Thoracic Stent Graft product brochure - 2

A D VA N C E D D E S I G N The Valiant Captivia system leverages Medtronic’s 13 years of thoracic stent graft experience and innovation. Our advanced design enhances confidence—and is proven in more than 40,000 implants. * P latinum iridium markers provide high visibility FreeFlo Configuration Evenly distributes radial force over multiple apices Absence of longitudinal bar allows for enhanced flexibility and kink resistance * Test data on file at Medtronic, Inc. Bench test results may not be indicative of clinical performance. V a l iant t h oracic stent graft W I T H T H E C aptivia D e l...

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Valiant Thoracic Stent Graft product brochure - 3

c o nfidence in c o n t r o l The Valiant Captivia system features tip capture of the proximal stent. Tip capture provides controlled deployment and placement when navigating the thoracic aorta. CONTROLLED DEPLOYMENT WITH TIP C APTURE Tip capture provides accurate stent graft placement After tip capture is released, Valiant conforms to the patient’s anatomy V a l iant t h oracic stent graft W I T H T H E C aptivia D e l iver y S y stem

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