FROM THE EVERYDAY TO THE EXTRAORDINARY
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2 FROM THE EVERYDAY TO THE EXTRAORDINARY Created with the collaboration of more than 250 physicians around the world, ENDURANT empowers you to create stronger outcomes for more patients, including those otherwise ineligible for EVAR. For a graft that is simple to control, provides greater access and durability, and conforms to a broader range of anatomies, ENDURANT is the one. Long, wide, flared and tapered limbs One-piece, laser cut nitinol suprarenal stent with anchor pins Low profile, hydrophilic delivery system for easy access Radiopaque markers for increased accuracy High density multi-filament polyester graft material Controlled release Suprarenal fixation Tip capture for accurate deployment Making real progress means answering real challenges. Our new go-to device transforms performance because we designed it with you, to give you exactly what you need to advance your command of the everyday to the extraordinary. 2 MEDTRONIC ENDOVASCULAR ENDURANT AAA STENT GRAFT SYSTEM 3
3 FLEXIBLE FIT CO M P L E T E CONFORMABILITY With shorter, super-elastic nitinol stents, ENDURANT conforms to a variety of anatomies, including tortuous iliac arteries and / M-shaped proximal stents provide wall apposition and minimize in-folding highly angulated necks. When your tools adapt to your patients, you can treat them even more effectively. Treat necks as short as PRE POST 10mm with angulation up to and including 60 2 / Suprarenal stent with anchor pins provide secure fixation Pre and Post One Month Follow Up of ENDURANT U.S. PMA Clinical Trial Patient 3 CONFORMABILITY Stiff stent grafts tend to straighten aortic and iliac anatomies. ENDURANT Stent Graft conforms to the natural tortuosity of the vessel. 3 / Limb stents and stent spacing reduce kinking 4 MEDTRONIC ENDOVASCULAR ENDURANT AAA STENT GRAFT SYSTEM 5
4 TOTAL CONTROL CONSISTENT PRECISION An advanced delivery system makes ENDURANT simple to place in straightforward and challenging anatomies. When you take control at each step, you can approach more targets with confidence. The ENDURANT Delivery System features a tip capture mechanism that allows you to adjust placement proximally or distally, even after deployment of up to three stent rings. The back-end thumb wheel provides controlled release of the suprarenal stent and anchor pins Tip capture mechanism allows for precise positioning adjustments Aim accurately with four proximal markers e -shaped marker assists with A/P orientation Ease contralateral limb placement with the flow divider marker Improve cannulation with the contralateral gate marker 0.0% stent graft migration after one year (0/125 patients) ENDURANT U.S. PMA Clinical Data 6 MEDTRONIC ENDOVASCULAR ENDURANT AAA STENT GRAFT SYSTEM 7
5 L O W P R O F I L E EASY ACCESS Hydrophilic coating to facilitate stent graft delivery BIFURCATED AAA DEVICE OUTER DIAMETER PROFILES 28 mm Medtronic Endurant, Cook Zenith Bifurcated Devices and 28.5 mm Gore Excluder Bifurcated Device Medtronic Endurant Gore Excluder Cook Zenith ENDURANT improves access with a low-crossing profile and a hydrophilic coating, and achieves high trackability with a specially-processed, thinner-walled graft cover and flexible, kink-resistant delivery system. When you can respond with agility, you can deliver more success. Crossing Profile (OD) 20 F 20 F 1 23 F 2 Hydrophilic Coating Yes No Yes Bifur Limb 36 mm, 32 mm, 28 mm 20 F (OD)* 28 mm, 24 mm, 20 mm 16 F (OD)* 25 mm, 23 mm 18 F (OD)* 16 mm, 13 mm, 10 mm 14 F (OD)* *Outer diameter 1 Bench test data on file at Medtronic, Inc. Bench test data may not be indicative of clinical performance. The Gore Excluder IFU recommends using an 18 F Gore Introducer Sheath with its 28.5 mm Gore Excluder bifurcated main body device. The Gore DrySeal Sheath IFU indicates that the nominal OD of an 18 F Gore DrySeal Sheath is 6.8 mm, which is 20.4 F. 2 Bench test data on file at Medtronic, Inc. Bench test data may not be indicative of clinical performance. Cook s Physician Manual indicates that the OD of a 28 mm Cook Zenith bifurcated main body device is 7.7 mm, which is 23.1 F. 8 MEDTRONIC ENDOVASCULAR ENDURANT AAA STENT GRAFT SYSTEM 9
6 Suprarenal stent and anchor pins laser-cut from a single piece of nitinol for durability DURABLE BUILD SERIOUS STRENGTH Featuring a suprarenal stent and laser-cut anchor pins constructed from a single piece of nitinol, and high-density polyester graft material, ENDURANT is crafted to perform. When you know the quality you can expect, you can expect more. BEFORE POLISHING AFTER POLISHING / Ultra-high molecular weight polyethylene sutures that are three times stronger than surgical sutures 1 2 / High density multi-filament polyester graft material provides lower porosity for resistance against Type IV endoleaks 3 / Electropolished nitinol stent for greater strength 1 Bench test data on file. Medtronic; Santa Rosa, CA; Bench test data may not be indicative of clinical performance. 10 MEDTRONIC ENDOVASCULAR ENDURANT AAA STENT GRAFT SYSTEM 11
7 Endurant u.s. pma clinical data 12 MONTHS Freedom from aneurysm mortality 100% Aneurysm rupture 0.8% (1/133 patients) Conversion to surgery 0.0% (0/133 patients) Stent graft migration 0.0% (0/125 patients) Type I 0.0% (0/123 patients) P O W E R F U L D A T A EXCEPTIONAL RESULTS Type II 8.9% (11/123 patients) Type III 0.0% (0/123 patients) Type IV 0.0% (0/123 patients) ENDURANT TEST GROUP Anchoring pin fracture 0.0% (0/129 patients) Technical Success % (149/150 patients) Stent graft kinking/twisting 0.8% (1/129 patients) Stent graft wireform fracture 0.0% (0/129 patients) 30 DAYS Suprarenal bare stent fracture 0.0% (0/129 patients) Freedom from Major adverse events 96.0% Endurant AAA Stent Graft System Instructions for Use 1 Defined as the successful delivery and deployment of the stent graft 12 MEDTRONIC ENDOVASCULAR ENDURANT AAA STENT GRAFT SYSTEM 13
8 ENDURANT Product Codes 23, 25, 28, 32, 36 mm aortic extension proximal markers Bifurcations Contralateral Iliac Limbs Product Code Product Code BIFURCATED Proximal Markers Proximal Graft Distal Graft Distal Design Covered Length Delivery System Catheter (F) Proximal Graft Distal Graft Distal Design Covered Length Delivery System Catheter Outer (F) Contralateral Covered Length with Bifurcated* 23, 25, 28, 32, 36 mm ENBF C 124 E 18 ENBF C 145 E 18 ENLW C 82 E ENLW C 93 E ENBF C 166 E 18 ENLW C 124 E *, 50 mm 70 *, 80 mm BIFURCATED GRAFT 124 *, 145, 166 mm AORTIC EXTENSION 49, 70 mm 23, 25, 28, 32, 36 mm iliac extensions 10, 13, 20, 24, 28 mm p r o xi m a l m a r k e r s minimum 3 stent overlap 12, 14 mm Contralateral limb 16 mm P r o x i m a l M a r k e r s contralateral limb 82, 93, 124 mm ENBF C 124 E 18 ENBF C 145 E 18 ENBF C 166 E 18 ENBF C 124 E 18 ENBF C 145 E 18 ENBF C 166 E 18 ENBF C 124 E 18 ENBF C 145 E 18 ENBF C 166 E 18 ENBF C 124 E 20 ENBF C 145 E 20 ENBF C 166 E 20 ENBF C 124 E 20 ENBF C 145 E 20 ENBF C 166 E 20 ENBF C 124 E 20 ENBF C 145 E 20 ENBF C 166 E 20 ENBF C 124 E 20 ENBF C 145 E 20 ENBF C 166 E 20 ENBF C 124 E 20 ENBF C 145 E 20 ENBF C 166 E 20 ENLW C 82 E ENLW C 93 E ENLW C 124 E ENLW C 82 E ENLW C 93 E ENLW C 124 E ENLW C 82 E ENLW C 93 E ENLW C 124 E ENLW C 82 E ENLW C 93 E ENLW C 124 E ENLW C 82 E ENLW C 93 E ENLW C 124 E * Subtract total contralateral covered length of bifurcated by 10 mm when using the 124mm length bifurcated stent graft. Aortic Extensions Proximal Graft Product Code Distal Graft Distal Design Covered Length Delivery System Catheter Outer (F) ENBF C 145 E 20 ENCF C 49 E 18 ENBF C 166 E 20 ENCF C 49 E 18 COMPONENT PLACEMENT GUIDE iliac extension 82 mm minimum 3 stent overlap 13, 16, 20 mm 10, 13, 16, 20, 24, 28 mm ENBF C 145 E 20 ENBF C 166 E 20 Iliac Extensions Proximal Graft Product Code Distal Graft Distal Design Covered Length Delivery System Catheter (F) ENCF C 49 E 20 ENCF C 49 E 20 ENCF C 49 E 20 ENTF C 70 E 18 ENTF C 70 E 18 ENTF C 70 E 20 ENTF C 70 E 20 ENTF C 70 E 20 ENEW C 82 E 14 Multiple options for patient customization ENEW C 82 E 14 ENEW C 82 E 16 *Measurements for 124 mm length bifurcated stent graft ENEW C 82 E 16 ENEW C 82 E 18 10, 13, 20, 24, 28 mm 14 MEDTRONIC ENDOVASCULAR ENDURANT AAA STENT GRAFT SYSTEM 15
9 Indications The Endurant Stent Graft System is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms in patients with the following characteristics: Adequate iliac/femoral access that is compatible with vascular access techniques, devices and/or accessories Proximal neck length of 10 mm Infrarenal neck angulation of 60 Distal fixation length of 15 mm Aortic neck diameters with a range of 19 to 32 mm Iliac diameters with a range of 8 to 25 mm Morphology suitable for aneurysm repair Contraindications The Endurant Stent Graft 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 Endurant Stent Graft System has not been established. All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess the health and the performance of the implanted endovascular stent 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 Instructions for Use. Patients experiencing reduced blood flow through the graft limb, aneurysm expansion, and persistent endoleaks may be required to undergo secondary interventions or surgical procedures. The Endurant Stent Graft System is not recommended in patients unable to undergo or who will not be compliant with the necessary preoperative and postoperative imaging and implantation studies as described in the Instructions for Use. Renal complications may occur: 1) From an excess use of contrast agents. 2) As a result of emboli or a misplaced stent graft. The radiopaque marker along the edge of the stent graft should be aligned immediately below the lower-most renal arterial origin. Studies indicate that the danger of micro-embolization increases with increased duration of the procedure. The safety and effectiveness of the Endurant Stent Graft System has not been evaluated in some patient populations. Please refer to the product Instructions for Use for details. MRI Safety and Compatibility Non-clinical testing has demonstrated that the Endurant Stent Graft is MR Conditional. It can be scanned safely in both 1.5T & 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 (arranged in alphabetical order): Amputation; Anesthetic complications and subsequent attendant problems (e.g. aspiration), Aneurysm enlargement; Aneurysm rupture and death; Aortic damage, including perforation, dissection, bleeding, rupture and death; Arterial or venous thrombosis and/or pseudoaneurysm; Arteriovenous fistula; Bleeding, hematoma or coagulopathy; Bowel complications (e.g., ileus, transient ischemia, infarction, necrosis); Cardiac complications and subsequent attendant problems (e.g. arrhythmia, myocardial infarction, congestive heart failure, hypotension, hypertension); Claudication (e.g., buttock, lower limb); Death; Edema; Embolization (micro and macro) with transient or permanent ischemia or infarction; Endoleak; Fever and localized inflammation; Genitourinary complications and subsequent attendant problems (e.g., ischemia, erosion, fistula, incontinence, hematuria, infection); Hepatic failure; Impotence; Infection of the aneurysm, device access site, including abscess formation, transient fever and pain; Lymphatic complications and subsequent attendant problems (e.g., lymph fistula); Neurologic local or systemic complications and subsequent attendant problems (e.g., confusion, stroke, transient ischemic attack, paraplegia, paraparesis, paralysis); Occlusion of device or native vessel; Pulmonary complications and subsequent attendant problems; Renal complications and subsequent attendant problems (e.g., artery occlusion, contrast toxicity, insufficiency, failure); Stent graft: improper component 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; Surgical conversion to open repair; Vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula, dissection; Vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection, bleeding, rupture, death); Vessel damage; Wound complications and subsequent attendant problems (eg, dehiscence, infection, hematoma, seroma, cellulitis) 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. For distribution in the USA only Medtronic, Inc. All Rights Reserved. Printed in the USA. Trademarks are property of their respective owners. UC EN Rev A Medtronic CardioVascular 3576 Unocal Place Santa Rosa, CA USA Tel: Product Services Support Center Tel: Fax: CardioVascular LifeLine Customer Support Tel: Tel:
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