医療機器市販直後安全使用情報収集事業 結果について
Contents
1. ee ww ul2. 10
3. 4 7 5 1 Treatment Energy Treatment Time 2 Standby 3
4. 2 1 1 ELVeS INT01 01 45 5
5. 2010 6 15 1 22200BZX00660000 31 1 2 JIS C 6802 4 3 4
6. 1 ELVeS JMDN 36546000 2 AC100V 110VA 3 4 I B IPXO IPX8 4 260Wx380D x 220H mm 7 5kg 5 GaAs 980nm 30nm 635nm 10nm
7. TLA TLA 10mm TLA TLA 2 cm
8. 59 5 29 CRP 5 6 1 2 7 1
9. 2 3 20 18 20 799 4 1 3
10. PC 4mm 50 60Hz ELVeS INT01 01 1 5 2 20mm 596
11. 6 7 8 TLA 9 TLA 10 11 12 13
12. ELVeS 22 6 14 23 1 1 20mm J R 23 1 1 23 6 106 106 i a a SS a i fe
13. cm Et EE i 0 50 00 0 12 80 1 0 2 3 533 23q 6e sql 5q soc 269659 1 ze 2 0 gs A 1 mm B 1cm 4 1 0 035i 0 89mm 19G 2 TLA TLA 0 2
14. 3 1 2 3
15. 1 1 1 gt 1 Oh CK Jung DS Jang HS et al Endovenous Laser Surgery of the Incompetent Greater Saphenous Vein With a 980 nm Diode Laser Dermatol Surg 2003 29 1135 1140 2 Theivacumar N S et al Influence of Warfrin on the Success of Endovenous Laser Ablation EVLA of the Great Saphenous Vein GSV Eur J Vasc Endovasc Surg 2009 doi 10 1016 j ejvs 2009 05 022 3 Gerard JL Desgranges P et al Feasibility of ambulatory endovenous laserforthe treatment of greater saphenous varicose veins one month outcome in a series of 20 outpatients J Mal Vasc 2002 27 222 225 4 Pannier F et al Mid term results following endovenous laser ablation EVLA of saphenous veins with a 980 nm diode laser Int Angiol 2008 Dec 27 6 475 81 5 AGUS GB et al The first 1000 cases of Italian Endovenous laser Working Group IEWG Rationale and long term outcomes for the 1999 2003 period International Angiology Vol 25 No 2 P 209 215 June 2006 6 Mozes G Gloviczki P et al Extention of saphenous thrombus into the femoral vein A potential complication of new endovenous ablation techniques J Vasc Surg 2005 130 135 7 Proebstle TM et al Reduced recanalization rates of the great sap
16. 1 5
17. 1096 1 1 2 3 2 1 2 3 3 1 300 600 x m 2 3 4 40 70 cm
18. 3 7 3 4 5 ELVeS INT01 01 2 5 3 3 2 1 2 1cm 3 4 5
19. 2
20. 6 a a Cd 2 3 1 2 3 1
21. 2cm 0 1cm 3 Enable 3 4 1
22. 1cm 1 1 2 3 ABPI 0 9
23. 1 1 4 5 6 7
24. 14 15 16 17 18 19 20 CW 980nm 30nm 4 5D
25. 5mW 1W 15W 0 1W 5 3 x 107 W m 8596 NA 0 37 0 01 9 99 0 01 6 PN 980nm
26. 21 3 ELVeS 24 pF 7 1
27. 4 6 1 1 1 1 2
28. 1 0 3 4 1 2 3
29. S 9 9 35 35 56 5 20 20 66 7 23 24 37 1 8 8 26 7 2 12 19 4 2 2 6 7 7 7 11 3 1 1 3 3 i 6 6 97 3 3 100 CRP 5 5 8 1 2 2 100 3 3 4 8 1 1 3 3 2 2 3 2 3 3 100 2 2 3 2 1 1 3 3 1 1 1 6 3 3 100 1 1 1 6 12 17 400 0 0 0 1 1 3 3 18 22 29 0 11 13 36 7 55 120 88 7 28 75 93 3 10 50 C 10 lt 90 700 1060hPa
30. 5 1 1 2 1
31. 62 55 88 7 120 35 56 5 24 37 1 12 19 4 7 11 3 6 9 7 CRP 5 8 1 3 4 8 2 3 2 2 3 2 1 1 6 1 1 6 1 2
32. 4 5 10 ELVeS INT01 01 3 5 4 5 1 1009 6 CEAP C2 C4a C4 C6 1 C4 C6 Evidence Summary C6 C6 1
33. Index 71 31 S CIVIQ2 72 1 4 12 24 4 S I 62 S 30 I 1 3 0 3 S 2 7 1 4 p 0 0000 5 1 I 62 100 72 96 8 4 95 2 24 93 596 6 1 1 9 S 2 5 S S S I 2 I 20 S 38 79 62 S 30
34. 81 59 100 31 1 62 S 30 17 S CIVIQ2 72 1 4 12 24 AUC S QOL 1 60 S 30 I X 7 16 S 6 97 p 0 4142 CIVIQ2 The Second version of the Chronic Venous Insufficiency Questionnaire QOL 2 S VFI 1 S 4 I 62 S 30 4 I 5 668 1 815 62 07 S 5 245 1 775 61 16 VFI Venous Filling
35. henous vein after endovenous laser treatment with increased energy dosing Definition of a threshold for the endovenous fluence equivalent J Vasc Surg Oct 2006 834 839 8 Desmyttere J et al Endovenous 980nm laser treatment of saphenous veins in a series of 500 patients J Vasc Surg Dec 2007 9 Min RJ Khilnani N Zimmet SE Endovenous Laser Treatment of Incompetent Great Saphenous Vein J Vasc Interv Radiol 2001 12 1167 1171 10 Rasmussen LH et al Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins Shot term results J Vasc Surg Aug 2007 11 Theivacumar NS et al Endovenous laser ablation Does standard above knee greatsaphenous vein ablation provide optimum results in patients with both above and below knee reflux A randomized controlled trial J Vasc Surg 2008 48 173 8 12 Coleridge Smith PD Leg ulcer treatment J Vasc Surg Mar 2009 804 808 13 Kontothanassis D et al Endovenous laser treatment of the small saphenous vein J Vasc Surg April 2008 973 979 14 Viarengo LMA et al Endovenous Laser Treatment for Varicose Veins in Patients with Active Ulcers Measurement of Intravenous and Perivenous Temperatures during the Procedure Dermatol surg 2007 1234 1241 15 Launois R et al Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficienc
36. y CIVIQ Qual Life Res 1996 5 539 554 16 45 4 Jpn Coll Angiol 2005 45 323 328 17 5 2002 22 29 gt 1 17 11 BN Tel 03 3353 2630 Fax 03 3353 2672 http www integral to 1 17 11 BN Tel 03 3353 2630 Fax 03 3353 2672 Web http www integral to CeramOptec GmbH ELVeS INT01 01 5 5 6 21 5 22 8 1
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