Talent Abdominal Stent Graft

Transcription

1 Talent Abdominal with THE Xcelerant Hydro Delivery System Expanding the Indications for EVAR

2 Treat More Patients Short Necks The Talent Abdominal is the only FDA-approved device for proximal aortic neck length as short as 10 mm Angled Necks Approved for aortic neck angulation up to 60 degrees Designed with approximately 15 mm suprarenal stent length for conformability to angulated anatomy Large Necks Approved to treat up to 32 mm diameter necks Available in stent graft sizes from 22 to 36 mm Wide Range of Sizes Most extensive offering of main bodies and extensions on the market over 1,150 combinations Tapered and flared iliac limb sizes from 8 to 24 mm Full spectrum of sizes available up to 36 mm, including a 34 mm device Sized to Fit Each Patient Detailed sizing guidelines can be found in the IFU including vessel sizes treated, indications for use, crossing profile, and more Risks associated with improper sizing include kinking, migration, aneurysm enlargement, and loss of tissue ingrowth A Comparison of Device s Medtronic Talent Cook Zenith Gore Excluder Endologix Powerlink Size

3 Excellent Patient Outcomes Over 12 Years of Worldwide Experience 1 More than 50,000 patients treated worldwide Excellent Clinical Results U.S. PMA Pivotal Clinical Data at 1 Year 6 Freedom from Aneurysm-Related Mortality 97.9% Freedom from Rupture 100% Freedom from Conversion 100% Migration 0.8% Patency 100% U.S. Clinical Data at 5 Years 2 Freedom from Aneurysm-Related Mortality 96.5% Freedom from Rupture 98.2% Freedom from Conversion 99.1% Migration 2.3% Limb Thrombosis 0% Limb Kinking 0% Rate of Secondary Procedures 0% Gastrointestinal Events 3.2% Hematogenic Bleeding 1.1% Stroke 1.1% The long-term performance of endovascular grafts has not yet been established. All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess their health and the performance of their endovascular graft.

4 Multiple Options for Unique Patient Customization Aortic Extension mm Bifurcated Graft ~15 mm mm ~15 mm Align radiopaque markers for maximum extension mm ~15 mm 50 mm Radiopaque markers Flow divider 14 mm 30 mm Align radiopaque markers to ensure 30 mm overlap Contralateral Limb 14 mm 14 mm 15 mm Iliac Extension Connecting bar mm 30 mm Align radiopaque markers to ensure 30 mm minimum overlap mm 8-24 mm 8-24 mm

5 Talent Converter with the xcelerant hydro delivery system Talent Occluder with the OCCLUDER delivery system mm 8-24 mm ~15 mm mm Connecting Bar ~125 mm Radiopaque markers 16 mm F FreeFlo B Bare spring W Open web C Closed web Choose from various lengths, diameters, variable tapering and flaring, and an array of proximal and distal designs to create a stent graft to your specifications.

6 Designed to Deliver Low Profile xcelerant Hydro Delivery System facilitates stent graft treatment in patients with difficult access 3 System does not require a sheath, unlike Gore and Cook systems A Comparison of Delivery System Profiles 4,5 Talent Xcelerant Hydro Delivery System 6 Artery : 7.3 mm Gore Excluder System 7 Artery : 7.3 mm Cook Zenith System 8 Artery : 8 mm Delivery System : 22F Sheath : 22F Sheath : 24F Inner : N/A Inner : (18F) Inner : (20F) Sheath Not Required Sheath Required Sheath Required Hydrophilic Coating Designed to aid navigation through tight 6 and tortuous 3 iliacs Minimum 32 cm with hydrophilic coating for better deliverability No coating for catheter manipulation at least 15 cm Easy and Accurate Three-Step Deployment Proper device sizing and the Xcelerant Hydro Delivery System s hydrophilic coating can help minimize the risk of adverse events including iliac vessel rupture, perforation, or other deployment difficulties

7 Talent Abdominal with The Xcelerant Hydro Delivery System For Medtronic ordering information contact your Medtronic Field Representative. BIFURCATED CONTRALATERAL LIMBS AB2212C140XH AB2212C155XH AB2214C140XH AB2214C155XH AF2412C140XH AF2412C170XH AF2414C140XH AF2414C170XH AF2612C140XH AF2612C170XH AF2614C140XH AF2614C170XH AF2616C140XH AF2616C170XH AF2618C140XH AF2618C170XH AF2814C140XH AF2814C170XH AF2816C140XH AF2816C170XH AF2818C140XH AF2818C170XH AF2820C140XH AF2820C170XH AF3014C140XH AF3014C170XH AF3016C140XH AF3016C170XH AF3018C140XH AF3018C170XH AF3020C140XH AF3020C170XH AF3214C155XH AF3214C170XH AF3216C155XH AF3216C170XH AF3218C155XH AF3218C170XH AF3220C155XH AF3220C170XH AF3416C155XH AF3416C170XH AF3418C155XH AF3418C170XH AF3420C155XH AF3420C170XH AF3618C155XH AF3618C170XH AF3620C155XH AF3620C170XH IW1408C105XH IW1410C105XH IW1412C75XH IW1412C90XH IW1412C105XH IW1414C75XH IW1414C90XH IW1412C105XH IW1416C75XH IW1416C90XH IW1416C105XH IW1418C75XH IW1418C90XH IW1418C105XH IW1420C75XH IW1420C90XH IW1420C105XH IW1422C75XH IW1422C90XH IW1422C105XH IW1424C75XH IW1424C90XH IW1424C105XH AORTIC EXTENSIONS AXB2222W30XH AXF2424W30XH AXF2626W30XH AXF2828W29XH AXF3030W28XH AXF3232W28XH AXF3434W28XH AXF3636W26XH ILIAC EXTENSIONS IXW1010C81XH IXW1208C75XH IXW1212C81XH IXW1410C75XH IXW1414C80XH IXW1612C75XH IXW1616C80XH IXW1812C140XH IXW1812C80XH IXW1814C140XH IXW1814C75XH IXW1816C140XH IXW1816C80XH IXW1818C140XH IXW1818C80XH IXW1820C80XH IXW1822C80XH IXW1824C80XH IXW2016C74XH IXW2020C79XH IXW2218C74XH IXW2222C79XH Talent Converter with The Xcelerant Hydro Delivery System CVB2216C126XH CVF2416C126XH CVF2616C126XH CVF2816C126XH CVF3016C125XH CVF3216C125XH CVF3416C125XH CVF3616C124XH Talent Occluder with The occluder Delivery System OCL08US OCL10US OCL12US OCL14US OCL16US OCL18US OCL20US OCL22US OCL24US

8 The Talent Abdominal Indications The Talent Abdominal is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement having: Iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories; A proximal aortic neck length of 10 mm; aortic neck angulation 60 ; iliac artery fixation length of 15 mm; An aortic neck diameter of mm and iliac artery diameters of 8 22 mm; and Vessel morphology suitable for endovascular repair. Contraindications The Talent Abdominal 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 performance of endovascular grafts has not yet been established. All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess their health and the performance of their endovascular 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 Talent Abdominal 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 Talent Abdominal 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 Talent Abdominal 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 (not arranged in any particular order): Aneurysm enlargement; aneurysm rupture and death; aortic damage (including perforation, dissection, bleeding, rupture and death); arterial or venous thrombosis and/or pseudoaneurysm; bleeding, hematoma or coagulopathy; cardiac complications; claudication; death; embolization (micro and macro) with transient or permanent ischemia or infarction; endoleak; fever and localized inflammation; occlusion of device or native vessel; pulmonary/respiratory complications and subsequent attendant problems; renal complications and subsequent attendant problems; surgical conversion to open repair; vascular access site complications ;vascular spasm or vascular trauma; vessel damage; wound complications and subsequent attendant problems; stent graft complications: 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. 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. The Talent Converter with Xcelerant Hydro Delivery System Indications The Talent Converter with Xcelerant Hydro Delivery System is indicated for secondary endovascular intervention in patients having received prior endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms using the Talent or AneuRx Bifurcated s, in which there is inadequate proximal fixation, seal, overlapping of modular components or unattainable contralateral limb cannulation. The anatomical considerations are as follows: Iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories Adequate proximal fixation site: with a length from the lowest renal artery to the proximal fabric edge of the previously placed bifurcated stent graft between 0 mm and 34 mm with a vessel diameter of 18 mm and 32 mm proximal aortic neck angulation 60 relative to the long axis of the aneurysm Adequate distal fixation site: For the Converter used without an iliac extension the landing zone of the distal fixation site within the bifurcated graft segment of 16mm in diameter and at least 30 mm in overlap length (between the bifurcation and distal end of the Talent Converter) For the Converter used in combination with an iliac extension, distal fixation site within the iliac artery greater than 15 mm in length and 8 mm to 22 mm in diameter Contraindications The Talent Converter is contraindicated in: Patients who have a condition that threatens to infect the graft Patients with sensitivities or allergies to the device materials Patients with a pre-existing iliac extension with a distal diameter of 8 mm. Warnings and Precautions The long-term performance of endovascular grafts with secondary endovascular intervention using additional components has not yet been established. All patients receiving the Talent Converter should receive enhanced follow-up. Specific follow-up guidelines are described in the Instructions for Use. The Talent Converter is not intended as a stand alone device to repair abdominal aneurysms. Notes and References: 1. Talent on all delivery systems. 2. Data from Medtronic Clinical 5-year update. 3. Difficult access is defined as tortuous iliac anatomies. Bench testing data on file. 4. Crossing profile similar to or lower than closest competitors. 5. Competitive devices were tested with Cook Introducer sheaths, 18F with the Gore Excluder, and 20F with the Cook Zenith. Test units were all 28 mm bifurcated stent grafts. 6. Talent Abdominal Stent Graft System Instructions For Use. 7. Gore Excluder AAA Endoprosthesis Instructions for Use. 8. Zenith AAA Endovascular Graft Instructions For Use. Talent Converter continued - Rather, the Talent Converter is used for secondary repair of previously placed Talent or AneuRx Bifurcated s or in cases where contralateral gate cannulation is unattainable at the time of index procedure. Medtronic has conducted testing to evaluate mechanical interactions between the Talent Converter System and the pre-existing Talent or AneuRx Bifurcated. The Talent Converter System has not been evaluated for use with any other commercially available bifurcated stent grafts. Patients experiencing reduced blood flow through the graft limb, enlarging aneurysms and persistent endoleaks may be required to undergo secondary interventions or surgical procedures. An increase in aneurysm size and/or persistent endoleak may lead to aneurysm rupture. 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. The danger of micro-embolization increases with increased duration of the procedure. MRI Safety and Compatibility: Non-clinical testing has demonstrated that the Talent Converter 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. Potential Adverse Events Potential adverse events include (not arranged in any particular order): Aneurysm enlargement; aneurysm rupture and death; aortic damage (including perforation, dissection, bleeding, rupture and death); arterial or venous thrombosis and/or pseudoaneurysm; bleeding, hematoma or coagulopathy; cardiac complications and subsequent attendant problems; claudication; damage or dislodgement of pre-existing graft; death; embolization (micro and macro) with transient or permanent ischemia or infarction; endoleak; fever and localized inflammation; fistula (e.g. arteriovenous, lymph fistula) occlusion of device or native vessel; pulmonary/respiratory complications; renal complications; surgical conversion to open repair; vascular access site complications ;vascular spasm or vascular trauma; vessel damage; wound complications; stent graft complications: 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 and corrosion. 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. The Talent Occluder with Occluder Delivery System Indications The Talent Occluder with Occluder Delivery system is intended for endoluminal occlusion of the common iliac artery in order to prevent retrograde blood into the aneurysm sac when used in conjunction with a fem-fem bypass (for example, the Talent Occluder can be used in combination with the Talent Converter ). The anatomical considerations are as follows: Iliac/femoral access vessel morphology that is compatible with vascular access techniques and a delivery system profile of 17.5 French Common iliac vessel diameters between 6 mm and 20 mm Contraindications The Talent Occluder 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 performance of the Talent Occluder has not yet been established. All patients receiving the Talent Occluder should receive enhanced follow-up. Specific follow-up guidelines are described in the Instructions for Use. Renal complications may occur: 1)From an excess use of contrast agents 2)As a result of emboli. Studies indicate that the danger of micro-embolization increases with increased duration of the procedure. The safety and effectiveness of the Talent Occluder 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 Talent Occluder 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. Potential Adverse Events Potential adverse events include (not arranged in any particular order): Aneurysm enlargement; aneurysm rupture and death; aortic damage (including perforation, dissection, bleeding, rupture and death); arterial or venous thrombosis and/or pseudoaneurysm; bleeding, hematoma or coagulopathy; cardiac complications and subsequent attendant problems; claudication; dislodgement of pre-existing graft (for example, a Talent Converter);death; embolization (micro and macro) with transient or permanent ischemia or infarction; endoleak; fever and localized inflammation; pulmonary/respiratory complications; renal complications; surgical conversion to open repair; vascular access site complications ;vascular spasm or vascular trauma; vessel damage; wound complications and subsequent attendant problems; stent graft complications: 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. 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. Medtronic Vascular 3576 Unocal Place Santa Rosa, CA USA Tel: CardioVascular LifeLine Customer Support Tel: Tel: Product Services Tel: Fax: For distribution in the USA only Medtronic, Inc. All rights reserved. Printed in the USA. Trademarks are property of their respective owners. UC aEN 05/10