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1 SUPRA-RENAL STENT MAKES OUTCOMES. Endurant II/IIs AAA Stent Graft System
2 ENDURANT II FAMILY PRODUCT Endurant II/IIs Endurant II 2 ENDURANT II AAA STENT GRAFT SYSTEM
3 Expand Treatable Anatomy Endurant II AUI Endurant IIs 5 3
4 MEASURED IN RESULT 1,800 1 Medtronic Endurant II 1 EU EU Trial) ENDURANT France ENGAGE US US IDE AUI 3 44 ENGAGE 4 1,263 US IDE Trials and registry evaluated the Endurant Stent Graft System. 1. Data on file at Medtronic % 5 / * 0% 5 Type * 21 EVAR 21 Endurant 20 Endurant * US IDE: ENDURANT 2012 DEC Clinical Update 4 ENDURANT II AAA STENT GRAFT SYSTEM
5 ENGAGE % 0/490 Type / 3 1.5% 5/ % Patients at 3 years=388 ARM 98.4% Patients at 3 years= Site Reported. Endurant ENGAGE OUS Registry. Medtronic database. 2. Whole body migration. 3. Type I/III endoleaks reported at 3 years. US IDE N= * 2 * 3 ** 4 ** 5 ** Type 0/ % 1/ % 1/108 0/94 0/83 Type 9.1% 12/ % 11/ % 11/ % 9/94 7.2% 6/83 Type 0/132 0/121 0/108 0/94 0/83 / / % 125/ % 106/ % 98/ % 78/83 Trials and Registry evaluated the Endurant Stent Graft System. * Core Lab Data ** Site Report Data 5
6 M in-folding 4 6 ENDURANT II AAA STENT GRAFT SYSTEM
7 10mm 60 * * Endurant II10mm 60 7
8 4 X 8 ENDURANT II AAA STENT GRAFT SYSTEM
9 Lower Profile 18F 28mm graft e 9
10 3 23, 25, 28, 32, 36mm 23, 25, 28, 32, 36mm 23, 25, 28, 32, 36mm 40 *, 50mm 74, 84 *** mm 49, 70mm 124 *, 145, 166mm 23, 25, 28, 32, 36mm 82mm 10, 13, 20, 24, 28mm 13, 16, 20mm 12 **, 14mm 16mm 10, 13, 16, 20, 24, 28mm 50mm 84mm 82, 93, 124, 156, 199mm 3 16mm 10, 13, 16, 20, 24, 28mm 103mm 14mm 23, 25, 28, 32mm 3 5AUI 14mm 16mm 10, 13, 16, 20, 24, 28mm 82, 93, 124, 156, 199mm X e 10, 13, 20, 24, 28mm AUI 102mm * 124mm 40mm 49mm 9mm ** 23mm12mm *** 14mm 10 ENDURANT II AAA STENT GRAFT SYSTEM
11 Endurant II F ETBF C 124 EJ 18 ETBF C 145 EJ 18 ETBF C 166 EJ 18 ETBF C 124 EJ 18 ETBF C 145 EJ 18 ETBF C 166 EJ 18 ETBF C 124 EJ 18 ETBF C 145 EJ 18 ETBF C 166 EJ 18 ETBF C 124 EJ 18 ETBF C 145 EJ 18 ETBF C 166 EJ 18 ETBF C 124 EJ 18 ETBF C 145 EJ 18 ETBF C 166 EJ 18 ETBF C 124 EJ 18 ETBF C 145 EJ 18 ETBF C 166 EJ 18 ETBF C 124 EJ 18 ETBF C 145 EJ 18 ETBF C 166 EJ 18 ETBF C 124 EJ 20 ETBF C 145 EJ 20 ETBF C 166 EJ 20 ETBF C 124 EJ 20 ETBF C 145 EJ 20 ETBF C 166 EJ 20 ETBF C 145 EJ 20 ETBF C 166 EJ 20 ETBF C 145 EJ 20 ETBF C 166 EJ 20 F ESBF C 103 EJ 18 ESBF C 103 EJ 18 ESBF C 103 EJ 18 ESBF C 103 EJ 20 ESBF C 103 EJ 20 AUI F ETUF C 102 EJ 18 ETUF C 102 EJ 18 ETUF C 102 EJ 18 ETUF C 102 EJ 20 F mm mm ETLW C 82 EJ /122* 155 ETLW C 93 EJ /133* 166 ETLW C 124 EJ /164* ETLW C 156 EJ /196* ETLW C 199 EJ /239* ETLW C 82 EJ /122* 155 ETLW C 93 EJ /133* 166 ETLW C 124 EJ /164* ETLW C 156 EJ /196* ETLW C 199 EJ /239* ETLW C 82 EJ /122* ETLW C 93 EJ /133* ETLW C 124 EJ /164* ETLW C 156 EJ /196* ETLW C 199 EJ /239* ETLW C 82 EJ /122* 155 ETLW C 93 EJ /133* 166 ETLW C 124 EJ /164* ETLW C 156 EJ /196* ETLW C 199 EJ /239* ETLW C 82 EJ /122* 155 ETLW C 93 EJ /133* 166 ETLW C 124 EJ /164* ETLW C 156 EJ /196* ETLW C 199 EJ /239* ETLW C 82 EJ /122* 155 ETLW C 93 EJ /133* 166 ETLW C 124 EJ /164* ETLW C 156 EJ /196* ETLW C 199 EJ /239* * 124mm 156, 199mm F ETEW C 82 EJ 14 ETEW C 82 EJ 14 ETEW C 82 EJ 16 ETEW C 82 EJ 16 ETEW C 82 EJ 18 F ETCF C 49 EJ 18 ETCF C 49 EJ 18 ETCF C 49 EJ 18 ETCF C 49 EJ 20 ETCF C 49 EJ 20 ETTF C 70 EJ 18 ETTF C 70 EJ 18 ETTF C 70 EJ 18 ETTF C 70 EJ 20 ETTF C 70 EJ 20 70mm 11
12 日本メドトロニック株式会社 ストラクチャラルハート & エンドバスキュラー事業部 東京都港区港南 Tel: medtronic.co.jp 製造販売元 : 日本メドトロニック株式会社一般的名称 : 大動脈用ステントグラフト販売名 :ENDURANTⅡ ステントグラフトシステム医療機器承認番号 :22400BZX 特定保険医療材料区分 :146 大動脈用ステントグラフト (1) 腹部大動脈用ステントグラフト ( メイン部分 )1 標準型 2AUI 型 (2) 腹部大動脈用ステントグラフト ( 補助部分 ) 使用目的又は効果 警告 禁忌を含む使用上の注意等の情報につきましては製品の添付文書をご参照ください 2018 Medtronic, Inc. All rights reserved. Printed in JAPAN. Trademarks are the property of their respective owners. UC JA EV547_SP_SP_01
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