頭蓋内動脈ステント（脳動脈瘤治療用 Flow Diverter）適正 …

1 Flow diverter 3 2020 9 2013 3 23 1 2015 4 1 2 2020 9 1 3 1 Flow diverter 3 2020 9 2 ----- 2 2 ----- 3 3 ----- 4 ----- 5 1. ----- 7 (1) Pipeline (2) FRED ----- 9 (3) Surpass (4) 2. ---- 10 (1) (2) ---- 12 (3) (4) 3. (1) ---- 13 (2) (3) (4) ---- 14 (5) 4.

2 ---- 15 (1) (2) ---- 16 5. ---- 18 (1) (2) Pipeline (3) FRED (4) (5) -----19 6. -----21 -----33 -----35 3 2 10mm [1,2] [3] [4] clipping clipping [5] [6] [7] [8,9] [10,11] [12] [13]

3 Flow diverter FD [14,15,16] FD FD [17,18] [14,15] [19] [ ] [22,23] [24] 2012 12 FD Pipeline Covidien/Medtronic Pipeline Flex 2015 4 2014 Surpass Stryker FRED Terumo/Microvention Flow diverter 2013 3 2015 4 Pipeline 2 FD 4 3 2015 4 FD Flow diverter 2 [25]

4 FD FD 2 5 Pipeline Flex 2019 5 Pipeline Flex with Shield Technology 2019 8 FRED FRED 5mm Pipeline 2020 8 5mm FD 3 FD 5 l 1. FD Pipeline Flex Pipeline Flex with Shield Technology Medtronic FRED Terumo/Microvention Surpass Streamline Stryker Pipeline Maverick (Medtronic) FRED jr (Terumo/Microvention), Surpass Evolve (Stryker) Bravo Cerenovus/Johnson&Johnson Silk, Silk Vista BALT P64, P48 (Phenox) Derivo (Acandis) Turbridge (MicroPort) MFM Cardiatis l 2.

5 Pipeline 10mm 5mm FRED 5mm Surpass streamline 10mm 3. X 4. l 5.

6 MRI 6. FD 7. Pipeline 25 l 8. 6 9. 10. l 11. FD 12. FD FD 7 1. (1) Pipeline Embolization Device Medtronic Inc. Pipeline / / / / 1 9 10, 12, 14, 16, 18, 19, 20, 25, 30, 35mm 9 x10mm FD FD 2014 Pipeline Flex [26] CE 2008 6 The PED is intended for endovascular embolization of cerebral aneurysms.

7 2010 2010 The Pipeline Embolization Device is intended for use with or without embolic coils for the treatment of complex intracranial aneurysms that are not amenable to treatment with surgical clipping. Canadian licensing is limited to devices that are between mm and mm in diameter. 2011 4 The Pipeline Embolization Device (PED) is indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments. PMA Pipeline for Intracranial Treatment of Aneurysms PITA CE >4 mm <2 IA 31 47 Pipeline 16 ICA MCA VA VBA 1 Pipeline (46/47) 6 2 [27] Pipeline for Uncoilable or Failed Aneurysms (PUFS )

8 IDE >4 mm 10 25 mm 25 mm IA ICA petrous cavernous paraophthalmic IA 60 SAH 42 180 50% 180 108 mm 8 mm 85 10 25 mm 22 25 mm 1 PED 3 1 13 104 106 78 PED 95% 107 6 95% [28,29] International retrospective study of the pipeline embolization device Pipeline (IntrePED) 17 793 906 10mm FD morbi-mortality (67/793) (10mm 10mm ) [30] Pipeline Flex 36 12 methacryloyloxyethyl phosphorylcholine (MPC)

9 Pipeline Flex with Shield technology 2019 1 MPC 3nm Pipeline Flex with SHield Technology Embolization An International MulticEnter ObservationaL Post-Market StuDy (SHIELD) 21 204 1 50% Raymond-Roy grade 1 Dual antiplatelet therapy DAPT 7 1-6 3 single antiplatelet therapy(SAPT) 20% [31] 10mm Pipeline Prospective Study on Embolization of Intracranial Aneurysms with the Pipeline Device (PREMIER) 22 1 141 7mm ( Pipeline 1 1 50% 1 1 1 [32] 2020 8 5mm 9 (2) FRED Terumo/Microvention Inc.)

10 FRED FRED Flow-Redirection Endoluminal Device / X X LVIS flow diversion 48 5 / 13/7mm 45/39mm 3 Kocer 33 37 FRED 1 Flow diverter FRED 3%(1/33) 5 fish mouth 2-3 67% 4-6 80% [33] 15 531 579 Eupopean FRED study(EuFRED) 3 ( )mm (1-30)mm 1 FRED 90 morbidity mortality 20mm 6 1 1 [34] 2019 Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment (SAFE study) 13 103 98 1 71 10mm 71 15 9 8 66/90 neck (7) aneurysm remnant (17) 2 1 21 1 mRS5 2 morbidity [35] 162 165 FRED FD 163 mortality morbidity FRED 3-6 94% 12-24 96% 78% [36] 150 185 FRED FD OKM grade C-D 66%(31/47) (101/109) (12)