先進医療 B において使用される未承認等の医療機器について薬事承認
Contents
1.2.
3.
4.
5.
6. PREVAIL JAPAN 1 2 1 2 2 6 8 2 1 1 90 1
7. 14 1 2 3 2 9
8. 2 BY li 150 1 40mmHg 4 0m sec 0 8cm2
9. 10 2 2 Valve in Valve bailout
10. 1 IS05840 6 2 IS05840 8
11. Co 1 2 3
12. 160 0023 6 10 1 03 6894 0500 Edwards Lifesciences LLC Atrion Medical Products Inc 8 8 BT NT ER Edwards Lifesciences Transcatheter Heart Valve i 1
13. X C 1 8 er X
14. 3 Edwards SAPIEN Transcatheter Heart Valve 1 000 1 K556 2 22 800 2 K555 1 57 000 3
15. 6 7 X X 10
16. MSDS Material Safety Data Sheet
17. X
18. C lt xr 30 X QACT 250 1 5F 1 67mm 6F 2 0mm 4 8 2
19. 7 8 9 10 5 0mL 10 20mL 11 12 5 0
20. 2 X Y Y BALLOON 2 x 4 F X mL mm mL atm kPa 10
21. 1
22. 13 C 1 er 14 WO 0 2 3
23. C 1 5 5 56 26mm 9355AS326J 23mm XT 90300TFX23J 9300TFX26J 9355AS323J 9355AS23J 9355AS26J 93501S23
24. 861 000 A B A B 5 6 gt
25. 4 310 000 6 4 530 000 8 ES 4 310 000 5 10 0 215 500 4 310 000 4 525 500 4 4 530 000 1
26. 5 6 4 C 1
27. X X 180cm 260cmX0 035 0 89mm 0 085 0 89mm Ne2Am ON 15 85 50mL 3 8
28. X 6 X 50mmHg gt
29. 0 B I NR Pe yet B 2 9 11 25mg
30. PET ThermaFix TEE XT 5 22m 21 25m Ma 25 6 X 2 2 X
31. 0 035 gt 0 89mm Fee RE ES X X X 2 Td KN 9 9 3 2 8 9350IS23J 93501S26 AF 7 mm 7 8mmMAX 0 9mmMIN 0 037 MIN
32. X 50mmlg 1
33. metreleptin 1 1 4 12 HbA1c 2 5 3 25 2 5 5 2 4
34. 5mm 21 22F 24F 7mm 3 1 2 A B A B C A
35. 500mL 2 1 1 2 1
36. 15 85 Y 10 1 11 Pr Ss J lt o 1
37. 2 x 1 8 0 1 5 0 2 4 0 3 2 5 0 1 0 0 5 100
38. Vas amp 3 4 NN a ne A 1 1 lt WW MI 1 NN fH er 2 1 1 Edwards LO00 GL 1M kdwards 2013 6 25 1 22500BZX00270 07
39. 5 MRI AN MR Onditional XT MR Conditional MR MRI 5 8 Ss C 1 5 3 2500gauss cm 15 MR 2 0W kg SAR IEC60601 2 33 2 MR SAR 2 0W kg GE Signa MR Whole body coil 1 5 15 MRI 2 3C SAR 2 0W kg Whole body MR GE Signa
40. BALLOON WIRE 035 mL 5 X 24 Hs RNN 2 WW W w WNW Pp DD 2c 9355AS23J 0355AS26J 9 3atm 2 6atm BR N 334kPa 16mL 263kPa 20mL 7atm 7atm 709kPa 20mL 709kPa 28mL
41. Valve in Valve Valve in Valve 2 6 6 5000IU ACT 250 CG 75 100mg 200 300mg 1 3 1 6 4 20
42. 2 B XT 25 6 21 25 10 1 2 Js MO 2 E CEE 1 B 9
43. 18 8 14 15 16mm 24mm 16 6 CVA TIA 17 12 18 19 20 5cm
44. K 556 2 37 430 3 0 Jd 458 400 2 862 250 2 822 125 26 400 26 750 26 375 3 047 592 1 83 1 131 1 107 1 86 24 6 25 5 4 XT 1 2 C 1007 Hazard ratio 0 41 959 6 CI 0 30 0 58 30 pco o01 90 72 5 5 Standard therapy 8 0 0 6 12 18 24 Months since Randomgation No at Risk TAVR 179 115 100 89 64 Standard 179 86
45. 23 12 20 2 4 7 1 1 23 2 10 3 23 1 25 21 12 2 4 J a rs 7 0 2 H23 1 19 2
46. 21 22 XT WHO EMA TSE TSE TSE 23 24
47. 60245004 17541010 XT TSE 1
48. Fr 20
49. 0 5 cm27m2 2 NYHA II 3 STS 10 STS 10 4 5 1 1 Q Q CK MB 2 CK CK MB
50. KM 4 EGO 2 98 0 4095 5 13 94 1 2 98 1 2 98 1 2 99 2 2 99 2 316 0 796 9 5 97 9 1 99 6 0 100 0 5 17 92 1 i 508 0 16 4 0 29 69 9 14 94 1 40 82 4 ef Pa 6 2 KM B EE 1 TIA 13 92 5 25 84 4 2 98 9 2 98 9 10C 25C 1
51. AKO 1 8 1 3 2 3 4 5 6 1 XT 1 XT X
52. B B B B B 2 1 1 B 1 2 5 8 2 1 2 5 1 0 C1 a MultiLoc 17 700 3 1 23 AO MatrixMANDIBLE 7 ICD
53. B 19 1 1 24 7 31 0731 2 0731 2 0731 7 6 2 B 2 3
54. 3 27 88 5 6 27 75 0 2 37 94 5 3 37 91 7 2 2 2 Bow 2 3 1 3 3 3 1 1 3 2 EE 80 00 0 0 0 0 0 0 0 0 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 3 3 OH 00 0 mOD MO MO re D 00 0 mOD SW 0 0 mOD CO mOD 0 0 0 0 0 0 0 0 1 2 7 0 0 0 3 6 0 0 0 0 0 0 0 0 0 0 0 0 4 1 4 2 4 1 EE so 0
55. 0 4 2 WW A 1 3 7 6 PARTNER US 4 PARTNER US 5 1 5 2 5 1 1 A B 11 175 93 7 54 174 69 1 5 181 97 2 89 181 49 8 5 2 2 cm mmllg A 0 66 0 20 42 70 14 52 1 66 0 52 10 22 4 31 7 8 B 0 63 0 19 44 68 15 60 1 53 0 52 11 76 7 19 31 0 69 0 24 39 50 12 92 0 70 0 26 44 38 15 75 5 PARTNER US 6 1 6 2 1 580 50 12 48 10 27 0 65 0 21 43 13 15 6 1
56. 2 1 3 150 556 7 3 38 5 1 QOL gt
57. 37 22 10 1 23 1 1 A a Bi H22 12 20 UDL 15 SE Pe Ma NM ELVes
58. 2 4 4 30 6 5 3 6 7 8 9 10 11 LVEE 20 12
59. HDxt 3T software Yersion 14 LX MR 3 0 2 6C 3 0 GE Signa HDx MR software version 14 LX MR 10mm spin echo 30mm gradient echo 1 5 3 0 MR X
60. Pro 3 230 000 a 596 llesto 7 VR T Pro llesto VR T DX Pro 7 IOD DF4 Pro I lesto 7 VR DF4 Pro 7 IOCD Pro llesto DR Pro 3 290 000 596 4 410 000 7 IOD DF4 Pro Ilesto 7 DR I DF4 Pro 7 CRI D Pro llesto 7 HF T Pro llesto HF DF4 Pro C2 a EE RT XT C2
61. 49 30 17 therapy 1 2 ALL CAUSE MORTALITY AT 1 YEAR AND 2 YEARS 100 6 a o ee Edwards SAPIEN THV HR 95 Cl 0 56 0 43 0 73 wa log rank lt 0 0001 0 2 68 0 amp o 43 3 40 3 lt at 0 at 2 VrS 24 7 NNT 4 0 pts 12 18 24 Mont Edwards SAPIEN THV 17 138 124 110 Standard Therapy 179 121 85 62 42 New England Journal of Medicine Vol 366 No 18 May 3 2012 PARTNER Trial Cohort B W AA 1 LMyA bp SS 4 Ae a 1
62. C 1 CO 3 9 1 2 3 ACT 150 4
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