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審査報告書 - 医薬品医療機器総合機構

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2. 201 21300BZyY004440009 UO 21600BZyY00076000 0
3. 5 5 OUUUUL 0 30 6 5 5
4. LD Objective Performance Criteria O0 0 0 OPCU UU UU U 0 360 OOO 6 90 0 28 4060 15 80 64 4060 0 0 00 0 0 OPC 90 88 100 140159000000001 87 90 0 3554040 DO O00 30000000000000000000 000 19 70 O 2411220 O0 0 0O O CEAD 31 30 30 96 P 0 060 0 000 0000 0000000000360000000 6 CEAD 4 30 0 P 0 040 0 0 00 0000 0000000000000000000000000 60 27 7 78 2820 0000000000000000 0 8 0 0000 1 SAPPHIRE OOO CEA N 167 N 167 N 406 88 1
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7. 324 1 2 TCD Transcranial doppler sonography Y UUUUOUUUUUUUUOTU
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11. SAPPHIRE WOU O Angioguard O0 000 2UUUUUUUUUUUUOU 4 2 310 0 3 O0 0000 10 O 00 HOU UY 3 152 132 Feasibility Swedy 0 O00000 60 0 26 10 OUUUUY 300 UUU Major Adverse Event MAE 69 0826 D0 0000 310000 10 7 28 261 0 MAE OOO UD O Angioguard O O O0 00O 125 221760 7 1 6 85 0 O Angioguard O0 O0 000
12. 2 3 20 1 2 L 2004 Philip A et al Preventing Ischemic Stroke in Patients With Prior Stroke and Transient Ischemic Attack A Statement for Healthcare Professionals From the Stroke Council of the American Heart Association Stroke 30 1991 1994 1999 European Carotid Surgery Trialist s Collaborative Group MRC European Carotid Surgery Trial Interim results for symptomatic patients with severe 70 99 or with mild 0 29 carotid stenosis Lancet 337 1235 1243 1991 North American Symptomatic Carotid Endarterectomy Trial Collaborators Beneficial effect of carotid endarterectomy in symptomatic patients with high grade carotid stenosis N Engl J Med 325 445 453 1991 Endarterectomy for asymptomatic carotid artery stenosis Exective Committee for the Asymptomatic Carotid Atherosclerosis Study
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16. 200000000000000 00000000000 carotid endarterectomy
17. 600 900 4 2400 4 14 3600 00 CEAI OU orchi A OU OI MAEL D L 5 6 9
18. 044400 0 071 0 0 Ul Ul Ul 0 061 2002 80 10 0 2003 O80 31 002 20 2800 20079 70 15000 0 057 000000000000000 0 007 20040 120 310 00000000000 Fl HOU 2
19. CEAL CAS 0 3 3000000001 30000000 MAE 30000 96 CAs 30 4800 81670 000 CEA 9 600 16 1671 P 0 14 DO OO OOU0O OOO0U00U00 01360000 MAE 12 000 201670 O 19 200 32 1670 P 0 1d CEA 6 11
20. 9 OU OU Angioguard QUO 00000000 OU 20020 0 0 006 9 20070 7000000000000000 000 B 20000000 Medical Device Reporting 0 122 0 Mb oo o0o0000000000000000000000000000 0000000000000000000000000000 0 01640 fb oooo 00240 Mb bo D000000000000000000000000000000000000
21. rr o o o o o o o 0000000000000 0000 400 30000000000000000000 OO 4400 300000000000000000000000000000000 7000000000 22 7
22. 262 30 30 2 333 OU Ul Ul Ul 00 L L Oo HH L L L OU OUI L OU 0 OU OUI CEAD LDI 0000036000000 OP 5 Ul Ul Ul Ul Q Ul
23. EN1441 Risk Analysis of Medical Devices O O EN ISO 14971 Medical Devices Risk Management U 130 40 2000000 63 2 OUU Ul
24. 3 0 516 0 000000 84 14 1670 0 UU O CEA 3 0 5 67 155 639 40 3 4 CEA 02 O00000 CEA P N 167 167 N 406 30 9 0 15 167 10 2 17 167 0 85 12 8 52 406 17 4 29 167 3 0 6 5 167 0 00 15 0 61 406 8 4 14 167 3 0 5 167 0 06 3 2 13 406 0 0 0 167 4 2 7 167 0 01 0 0 0 406 9 0 15 167 10 2 17 167 0 85 13 3 54 406 17 4 29 167 3 0 6 5 167 0 00 15 5 63 406 8 4 14 167 3 096 5 167 0 06 3 4 14 406 0 0 0 167 4 8 8 167 0 01 0 0 0 406 1 2
25. 0 CEA QO000000000000000000000000000000000 DO00000000000000000 00 0 ECsT 0 NASCET Q AcAs O00 O UU carotid artery
26. O sog HUH HOU UU UV UYU Ul oo 190 80 30 000007 00000 O O0 J 0000000000 LO OU O0 J 00000 OOOD 180 60 280 4 9 50 80
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28. 190 80 30 0 U 0 0 000007 0 0 0 0 0 OU 0 0 0 0 OOO 180 60 280 0000000 OU 190 80 3 0 0 000007 0 0 0 0 0 OU 0 0 0 0 180 6 280 0 360
29. UI Fn Hw OH OH OA 0 60 OOUUUUI CEA OOO00 SAPPHIREQ OOO CEAQ OOO CEA 50 0 0 U 60 1 CEA 80 s00 00 5 7
30. CEA UI 000000000 propensity score OU OUI OUI OU OU OUI OUI L L a 15 CASI CEAQVOUOOUUUU000UUUCEA ceap oill
31. OOUUUUU O SAPPHIRE 29 OU 34000000 0U0U00UU0UU0UN 2900 4130000 CEADUUUUUDUTI 8 00 000000701 6 6 CEAQUUUUL 406
32. JAMA 273 1421 1428 1995 21
33. 140 159 N A N A 87 9 355 404 91 2 145 159 N A 89 6 363 405 95 6 152 159 N A N A 91 69372 406 360 ooo 19 7 24 122 31 3 30 96 0 06 27 79 78 282 360 15 6 19 122 13 5 13 96 070 18 4 52 282 360 TLR 0 60 4 30 0 04 0 80 360 MAE 12 20 20 10 0 05 16 00 30 MAE 4 8 8 167 9 6 16 167 0 14 5904728206 1 2 2 167 2 4 4 167 0 68 2 2 9 406 MI 2 4 4 167 6 0 10 167 0 17 1 7 7 406 3 6 6 167 _3 0 5 167 10 4 994 20 406 360 MAE 12 0 20 167 19 2 32 167 0 10 15 8 64 406 7 2 12 167 12 6 21 167 0 14 1019641 406 6 0 10 167 7 2 12 167 0 83 9 1 37 406 0 6 1 167 3 0 5 167 0 21 3 2 13 406 3 6 6 167 1 896 3 167 0 50 3 99616 406 9 0 15 167 10 29617167 0 85 13 394 54 406 0 17 4 0 29 1670 OU CEA
34. 000000007 0 000000 50 Co OOD Fw Oo OO OH OH OOOOOSAPPHIRED OOOO CASOUUUUUUUUUTI CEAL CASI oOooogogoogogd 17

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