AneuRx AAAdvantagE Stent Graft with Xcelerant® Hydro Delivery System Medtronic Ordering Information Contact your Medtronic sales representative BIFURCATED Xcelerant® Hydro System—Designed to Deliver Expect the same ease of use, accuracy, and control—now with advanced hydrophilic technology to aid stent graft delivery Drag/Friction Force of Outer Sheath2 Reduced Friction Xcelerant Delivery System Hydrophilic coating to aid navigation through tight and tortuous iliacs Product Code Aortic Diameter (mm) Iliac Diameter (mm) Stent Graft Length (cm) Catheter Diameter (F) BFXCH2012135 20 BFXCH2012165 20 12 13.5 21 12 16.5 BFXCH2213135 22 21 13 13.5 21 BFXCH2213165 BFXCH2414135 22 13 16.5 21 24 14 13.5 21 BFXCH2414165 24 14 16.5 21 BFXCH2615135 26 15 13.5 21 BFXCH2615165 26 15 16.5 21 BFXCH2816135 28 16 13.5 21 BFXCH2816165 28 16 16.5 21 ILIAC LIMBS (STRAIGHT) Product Code 68x reduction in friction Xcelerant Hydro Delivery System 0 2 4 6 8 10 12 14 Force (N) Dual Taper Currently the only dual-tapered sheath on the market facilitates insertion and retraction of entire delivery catheter 21F 18F Low Profile Low profile characteristics for excellent tracking and access through small vessels 28 mm Bifurcated AAA Device Outer Diameter Profiles3-5,a 16 ILIAC LIMBS (FLARED) Stent Graft Catheter Diameter Length Diameter (mm) (cm) (F) Inner Diameter N/A Outer Diameter: 21.4F Sheath Not Required a Excluder ® Inner Diameter (18F) Outer Diameter: 22F Sheath Required Zenith ® Inner Diameter (20F) Outer Diameter: 24F Sheath Required ompetitive devices were tested with Cook introducer sheaths, 18F with the Gore Excluder, and 20F C with the Cook Zenith. Product Code Proximal Distal Stent Graft Catheter Diameter Diameter Length Diameter (mm) (mm) (cm) (F) ILXCH121285 12 8.5 16 >ILXCH1620115 16 20 11.5 19 ILXCH1212115 12 11.5 16 >ILXCH1620135 16 20 13.5 19 >ILXCH1212135 12 13.5 16 >ILXCH1822115 18 22 11.5 19 ILXCH131385 13 8.5 16 >ILXCH1822135 18 22 13.5 19 ILXCH1313115 13 11.5 16 >ILXCH1824115 18 24 11.5 19 >ILXCH1313135 13 13.5 16 >ILXCH1824135 18 24 13.5 19 ILXCH141485 14 8.5 16 ILXCH1414115 14 11.5 16 >ILXCH1414135 14 13.5 16 ILXCH151585 15 8.5 16 ILXCH1515115 15 11.5 16 >ILXCH1515135 15 13.5 16 ILXCH161685 16 8.5 16 ILXCH1616115 16 11.5 16 >ILXCH1616135 16 13.5 16 >ILXCH181885 18 8.5 19 >ILXCH1818115 18 11.5 19 >ILXCH1818135 18 13.5 19 >ILXCH202085 20 8.5 19 >ILXCH2020115 20 11.5 19 >ILXCH2020135 20 13.5 19 ILIAC EXTENDER CUFFS (STRAIGHT) AneuRx AAAdvantage® Contraindications There are no known contraindications currently associated with this device. Stent Graft Catheter Length Diameter (cm) (F) Product Code Diameter (mm) IEXCH121255 12 5.5 16 IEXCH131355 13 5.5 16 IEXCH141455 14 5.5 16 IEXCH151555 15 5.5 16 IEXCH161655 16 5.5 16 >IEXCH181855 18 5.5 19 >IEXCH202055 20 5.5 19 ILIAC EXTENDER CUFFS (FLARED) Product Code Proximal Distal Stent Graft Catheter Diameter Diameter Length Diameter (mm) (mm) (cm) (F) >IEXCH162085 16 20 8.5 19 >IEXCH182285 18 22 8.5 19 >IEXCH182485 18 24 8.5 19 > I ndicates expanded product offerings with AneuRx AAAdvantage. AORTIC EXTENDER CUFF Stent Graft Catheter Length Diameter (cm) (F) Product Code Diameter (mm) AEXCH202040 20 4 21 AEXCH222240 22 4 21 AEXCH242440 24 4 21 AEXCH262640 26 4 21 AEXCH282840 28 4 21 NOTE: Aortic extender cuffs do not feature Resilient graft material. Medtronic CardioVascular Product Services 3576 Unocal PlaceTel: 800.961.9055 Santa Rosa, CA 95403 Fax: 800.929.2133 USA Tel: 707.525.0111 www.Medtronic.com References: 1. AneuRx® AAA Stent Graft System Clinical Update—Volume IV. Medtronic, Inc. 2007. 2. Data on file. Medtronic CardioVascular; Santa Rosa, CA.; 2007. 3. AneuRx AAAdvantage® Stent Graft with Xcelerant® Hydro Delivery System Instructions for Use. 4. Gore Excluder® AAA Endoprosthesis Instructions For Use. 5. Zenith® AAA Endovascular Graft Instructions For Use. 6. Heikkinen MA, Alsac JM, Arko FR, Metsänoja R, Zvaigzne A, Zarins CK. The importance of iliac fixation in prevention of stent graft migration. J Vasc Surg. 2006;43(6):1130-1137. Warnings and Precautions FDA approval of the AneuRx device on September, 28, 1999 was based upon one-year follow-up data. The clinical information in this Brief Statement has been updated from the information originally submitted to the FDA for approval to include updated clinical information available to Medtronic as of August 1, 2003 (the clinical data freeze date for the 2003 PMA Annual Report). The AneuRx Stent Graft is intended to prevent rupture of abdominal aortic aneurysms. however, this risk is not completely eliminated. Based on reports received for patients enrolled in all phases of the clinical study, through August 1, 2003, ruptures have occurred in 2/1193 (0.167%) patients during the operative period; in 3/1193 (0.251%) patients within 30 days of treatment; and in 15/1193 (1.257%) patients greater than 30 days after treatment. The one-year freedom from rupture rate for patients enrolled in all phases of the clinical study is 99.5%; the two-year freedom from rupture rate is 98.6%; the three-year freedom from rupture rate is 98.5%; the four-year freedom from rupture rate is 97.2%; and the five-year freedom from rupture rate is 97.2%. 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, aneurysm size, and occlusion of vessels in the treatment area. Significant aneurysm enlargement (>5 mm), the appearance of a new endoleak, evidence of perigraft flow, change in aneurysm pulsatility, or migration resulting in an inadequate seal zone should prompt further investigation and may indicate the need for additional intervention or surgical conversion. Exercise care in the handling and delivery technique to aid in the prevention of vessel rupture. If an AneuRx Stent Graft is placed with less than one centimeter length of nonaneurysmal tissue at the proximal or distal end attachment sites, there is potential for leaking or migration due to inadequate apposition of the stent graft. • Inappropriate patient selection may contribute to poor device performance. Preliminary data indicate that patients with an aortic neck angle >45 degrees may have a higher likelihood of suboptimal outcomes compared to patients with an aortic neck angle <45 degrees. The same data indicate that patients with an aortic seal length of <15 mm and an iliac seal length of <25 mm may also have a higher likelihood of sub-optimal outcomes. • This device should only be used by physicians and teams trained in vascular interventional techniques, including training in the use of the device. • Do not use the AneuRx Stent Graft in patients unable to undergo the necessary preoperative and postoperative imaging and implantation studies. • The results of the clinical studies indicated that patients who experience an unsuccessful endovascular repair attempt, and as a result undergo conversion to surgical Abdominal Aortic Aneurysm (AAA) repair, are likely to have increased complications arising from both procedures (i.e., cardiac complications, fever, infection, musculoskeletal complications, neurological complications, pulmonary complications, vascular disease, vessel dissection, wound healing issues, and mortality). • The safety and effectiveness of the AneuRx Stent Graft System for the treatment of abdominal aortic aneurysms have not been evaluated in patients: – With aneurysms pending rupture – With connective tissue disorder – With hypercoagulability – With mesenteric artery occlusive disease – With ilio-femoral, thoracic, or inflammatory aneurysms – With juxtarenal AAA – With pararenal AAA – With suprarenal or thoracoabdominal aneurysms – Who are morbidly obese – Pregnant or nursing – Less than 18 years old – With less than one-year life expectancy • Always have a vascular surgery team available at institutions performing endovascular grafting in the event that conversion to open surgical repair is required. Patient Selection, Treatment and Follow-Up • Do not use this device in patients having an active systemic infection. • Do not use this device in patients with sensitivities or allergies to the device materials. The materials include: polyether block amide (PEBA); polyether block amide (PEBA) with tungsten filler; polyether block amide (PEBA) with barium sulfate filler; acrylonitrilebutadiene-styrene (ABS) copolymer; glass-filled acrylonitrile-butadiene-styrene (ABS) copolymer; polyetheretherketone (PEEK); polyvinyl chloride (PVC); stainless steel; ethylene propylene rubber; Nylon; silicone; polycarbonate; cyanoacrylate; nickel/titanium (nitinol); tantalum; and polyester. The AneuRx Stent Graft with Xcelerant Delivery System is latex-free. • The results of the clinical study indicate that women treated with this device may have a higher mortality rate as compared to their male counterparts. • The use of this device requires administration of radiographic agents. Patients with preexisting renal insufficiency may have an increased risk of renal failure postoperatively. • Proper use of this device requires accurate fluoroscopic imaging. This device is not recommended for patients whose weight exceeds 350 lb (150 kg) or whose weight may impede accurate fluoroscopic imaging. • Regular follow-up including imaging of the device should be performed every 3 to 6 months for patients in the enhanced surveillance group and at least every 6 to 12 months for patients in the routine surveillance group (see IFU for patient follow-up recommendations). During the recommended follow-up imaging schedule, patients should be monitored for aneurysm size, occlusion of vessels, change in pulsatility, migration, leaks, and device integrity. • Additional treatment including endovascular treatment or surgical conversion should be strongly considered in the following cases: – Aneurysm growth >5 mm (with or without leak) since last follow-up – Change in aneurysm pulsatility (with or without growth or leak) – Persistent endoleak with or without aneurysm growth – Stent graft migration resulting in an inadequate seal zone • The results of the clinical study indicate that subjects experiencing reduced blood flow through the graft limbs and/or leaks may be required to undergo secondary interventions or minor surgical procedures. • Non-clinical testing has demonstrated that the AneuRx Stent Graft is MR Conditional. It can be scanned safely under the following conditions: – Static magnetic field of 3-Tesla or less – Spatial gradient field of 720 Gauss/cm or less – Maximum whole-body-averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning. Adverse Events Death, AAA rupture, bleeding, cardiac failure/infarction, edema, wound healing complications, impotence, pulmonary complications, renal failure, gastrointestinal complications, arterial vascular occlusion, and venous vascular occlusion. Potential adverse events include: arterial and venous occlusion (includes thrombosis and thromboembolism), arterial trauma/dissection/perforation, bleeding, cardiac failure/infarction, central or peripheral nervous system impairment, coagulopathy, death, edema, endoleak, erosion with fistula or pseudo-aneurysm, gastrointestinal complications, graft dilatation, graft migration, graft occlusion, impotence, infection, loss of device integrity: stent fractures, graft wear holes, suture breaks, pulmonary/respiratory complications, renal insufficiency/failure, ruptured vessel/aneurysm, and wound healing complications. Please reference appropriate product Instructions for Use for a more detailed list of indications, warnings, precautions and potential adverse events. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. AneuRx AAAdvantage® Stent Graft with Xcelerant® Hydro Delivery System For distribution in the USA only. ©2008 Medtronic, Inc. All rights reserved. Trademarks are the property of their respective owners. UC200804112EN 1/08 Indications The AneuRx Stent Graft System is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms having: • Adequate iliac/femoral access • Infrarenal nonaneurysmal neck length of greater than 1 cm at the proximal and distal ends of the aneurysm and an inner vessel diameter approximately 10-20% smaller than the labeled device diameter • Morphology suitable for endovascular repair • One of the following: – Aneurysm diameter of >5 cm – Aneurysm diameter of 4-5 cm which has also increased in size by 0.5 cm in the last 6 months – Aneurysm which is twice the diameter of the normal infrarenal aorta. ® Designed to deliver The Evolution of the 7th Generation— Built on a Solid Foundation Post-Market Clinical Data Are More Reflective of Current Implant Techniques and Designs AAAdvantage Stent Graft—Designed to Perform AneuRx AAAdvantage® Stent Graft System is safe and effective, without compromise, for your EVAR procedures1,a Contemporary clinical data continue to show the safety and efficacy of the AneuRx platform AAAdvantage stent graft is uniquely designed with 3 methods of fixation for better stability, durability, and performance, leading to improved patient outcomes 1 Post-Market Surveillance Resultsa • Eleven years of continuous improvement in techniques and design Three Methods of Fixation Columnar Strength Superior columnar strength2 facilitates graft stability using solid anatomical fixation6 • The most robust long-term data set of any AAA stent graft • The most implanted AAA stent graft in the world No. of Patientsb Results Migration 334 1 AneurysmRelated Rupture 334 1 c Radial force Active, high radial force2 offers excellent support and conformability with aortic wall • The most peer-reviewed publications of any AAA stent graft a Results from 600 patients followed out to 5 years demonstrate freedom from aneurysm-related rupture 97% and freedom from aneurysm-related death 96%. Trusted Leader in Endovascular Stent Graft Innovation 2002 1998 2004 2006 2008 FDA Approval 1999 a These results reflect the Society for Vascular Surgery Lifeline Registry (LR) and the Medtronic-sponsored Post-Market Surveillance (PS) registry. b Combined LR (n=185) and PS (n=149) registries, total (n=334). Enrollment and 5-year follow-up are still continuing for the PS registry. c igration was defined for both registries as longitudinal movement of all or part of a stent or attachment system for a distance of M greater than 5 mm relative to anatomical landmarks determined at the time of the initial endovascular procedure. Designed for enhanced circumferential fixation and sealing Eleven years of experience and testing Lumen NiTi Struts Continuum of Innovation 1st-Generation • “Stiff Body” stent design • Pre-RPM graft material • “Bullet” Delivery System Exoskeleton provides a structure for tissue ingrowth and friction 2005 1996 1996 to 1999 Clinical Trial Exoskeleton Vessel wall 2nd-Generation • Flex-body stent design introduced • 1 cm stent rings for greater conformability • “Reduced Porosity Material” graft 3rd-Generation •Xpedient® Taper Tip Delivery System introduced •Lubricated coating on inner wall of graft cover •Anatomical recommendations added to IFU Durable Fixation 4th-Generation • Resilient graft material • High-density polyester graft material • Low porosity and excellent durability2 1996 5th-Generation • Xcelerant Delivery System introduced • Integrated handle for greater control • Radiopaque markers for increased accuracy 6th-Generation AAAdvantage SG • Enhanced, strategically placed RO markers • Extended aortic body •Longer, wider and flared limbs 1999 2001 2003 2005 Provide active high radial force, durable fixation, seal, and lumen patency Present 7th-Generation Xcelerant Hydro System Super-Elastic Nitinol Struts Offer dynamic conformability to a variety of neck shapes • Reduced friction to aid navigation2 •Facilitates insertion and retraction • Low profile characteristics > There were no reports of migration in the PS registry 1 Solid Anatomical Fixation Device Conformability with columnar support anchored at the hypogastric bifurcation6 One-centimeter long, diamond-shaped stent segments provide great anatomical conformability