IBE, s.r.o. www.silimedimplantaty.sk [email protected]

IBE, s.r.o.
www.silimedimplantaty.sk
[email protected]
&RQWRUQR&RUSRUDO
%RG\&RQWRXULQJ
'HVGH R LQtFLR GRV DRV SURGX
]LQGR SURGXWRV GH DOWD WHFQRORJLD
H TXDOLGDGH D 6LOLPHG DSUHVHQWD
D PDLRU JDPD GH LPSODQWHV SDUD R
FRQWRUQRFRUSRUDOWRGRVUHDOL]DGRV
HP SDUFHULD FRP FLUXUJL}HV
HVSHFLDOL]DGRVQRDVVXQWR
6LOLPHG KDV EHHQ SURGXFLQJ KLJK
WHFKKLJKTXDOLW\SURGXFWVVLQFHWKH
EHJLQQLQJ RI WKH V DQG SUHVHQWV
WKH ZLGHVW UDQJH RI LPSODQWV IRU
ERG\ FRQWRXULQJ DOO LQ SDUWQHUVKLS
ZLWK VXUJHRQV VSHFLDOL]HG LQ WKH
DUHD
&RQWRXU&RUSRUHO
&RQWRUQR&RUSRUDO
6SpFLDOLVp GHSXLV OHV DQQpHV GDQV OHV SURGXLWV GH WHFKQRORJLH
GH SRLQWH HW GH KDXWH TXDOLWp
6LOLPHGSURSRVHXQHDPSOHJDPPH
G¶LPSODQWV GHVWLQpV DX FRQWRXU
FRUSRUHO WRXV PLV DX SRLQW HQ
SDUWHQDULDW DYHF GHV FKLUXUJLHQV
VSpFLDOLVpVHQODPDWLqUH
'HVGHHOLQLFLRGHORVSURGXFLHQGR
SURGXFWRV GH DOWD WHFQRORJtD \
FDOLGDG 6LOLPHG SUHVHQWD OD PD\RU
JDPDGHLPSODQWHVSDUDHOFRQWRUQR
FRUSRUDOWRGRVLGHDGRV\UHDOL]DGRV
MXQWRDFLUXMDQRVHVSHFLDOLVWDVHQHO
DVXQWR
,03/$17(*/Ô7(248$57=2
48$57=2*/87($/,03/$17
&RP DQRV GH H[SHULrQFLD QD
IDEULFDomRGHLPSODQWHVJO~WHRVD6LOLPHG
UHXQLX WRGD VXD H[SHULrQFLD j DQRV GH
SDUFHULDFRPRVVHXVFOLHQWHVHQDGpFDGD
GHODQoRXRVHXSUySULRPRGHORR
*O~WHR4XDUW]R (VWD OLQKD UHSUHVHQWD R
TXHKiGHPHOKRUQRVLPSODQWHVJO~WHRV
GH QRVVD HPSUHVD XQLQGR D PDLV DOWD
WHFQRORJLDjVGLYHUVDVWpFQLFDVFLU~UJLFDV
WUD]HQGR XP UHVXOWDGR HVWpWLFR PXLWR
QDWXUDO
:LWK \HDUV H[SHULHQFH LQ
PDQXIDFWXULQJ JOXWHDO LPSODQWV 6LOLPHG
JDWKHUHG DOO LWV H[SHULHQFH IURP \HDUV
RISDUWQHUVKLSZLWKLWVFOLHQWVDQGLQWKH
GHFDGH RI ODXQFKHG LWV RZQ ODWHVW
PRGHO WKH 4XDUW]R*OXWHDO 7KLV OLQH
UHSUHVHQWV WKH EHVW LQ JOXWHDO LPSODQWV
IURP RXU FRPSDQ\ XQLWLQJ WKH KLJKHVW
WHFKQRORJ\ ZLWK GLYHUVH VXUJLFDO
WHFKQLTXHV LQ RUGHU WR SURYLGH D YHU\
QDWXUDOHVWKHWLFUHVXOW
6XDVFDUFDWHUtVWLFDV
e DSUHVHQWDGR FRP D EDVH RYDO H
SRVVXLGXDVSURMHo}HV
$ SDUWH PDLV SURMHWDGD GR LPSODQWH
FRUUHVSRQGH j SDUWH PpGLD GD UHJLmR
JO~WHD $VVLP D SURMHomR VHUi PDLRU
RX PHQRU GH DFRUGR FRP D HVFROKD GD
SURMHomRGRLPSODQWH
&KDUDFWHULVWLFV
3RVVHVVHV DQ RYDO EDVH DQG WZR
SURMHFWLRQV
7KH PRVW SURPLQHQW SDUW RI WKH
LPSODQWFRUUHVSRQGVWRWKHPLGGOHUHJLRQ
RIWKHEXWWRFN,QWKLVZD\WKHSURMHFWLRQ
FDQ EH JUHDWHU RU VPDOOHU GHSHQGLQJ RQ
WKHSURMHFWLRQRIWKHLPSODQWFKRVHQ
,03/$17(*/Ô7(248$57=2
,03/$17)(66,(548$57=2
&RQ DxRV GH H[SHULHQFLD HQ OD
IDEULFDFLyQGHLPSODQWHVJO~WHRV6LOLPHG
XQLy WRGD VX H[SHULHQFLD D ORV DxRV GH
DOLDQ]DFRQVXVFOLHQWHV\HQODGpFDGDGH
ODQ]yVXSURSLRPRGHORHOLPSODQWH
*O~WHR4XDUW]R (VWD OtQHD UHSUHVHQWD OR
TXH KD\ GH PHMRU HQ LPSODQWHV JO~WHRV
GH QXHVWUD HPSUHVD \D TXH XQH OD PiV
DOWD WHFQRORJtD D ODV GLYHUVDV WpFQLFDV
TXLU~UJLFDV \ WUDH XQ UHVXOWDGR HVWpWLFR
PX\QDWXUDO
*UkFH j VHV DQQpHV G¶H[SpULHQFH
GDQVODIDEULFDWLRQG¶LPSODQWVIHVVLHUVHW
j OD FROODERUDWLRQ GH VD ILGqOH FOLHQWqOH
6LOLPHG D ODQFp VRQ SURSUH PRGqOH HQ
O¶DQOH)HVVLHU4XDUW]R&HWWHOLJQH
UHSUpVHQWH FH TXL H[LVWH GH PHLOOHXU
GDQV OH GRPDLQH GHV LPSODQWV IHVVLHUV
GH QRWUH HQWUHSULVH DOOLDQW j OD SOXV
KDXWH WHFKQRORJLH GLYHUVHV WHFKQLTXHV
FKLUXUJLFDOHV DILQ G¶DVVXUHU OH UpVXOWDW
HVWKpWLTXHOHSOXVQDWXUHO
6XVFDUDFWHUtVWLFDV
6H SUHVHQWD FRQ EDVH RYDO \ SRVHH
GRVSUR\HFFLRQHV
/DSDUWHPiVSUR\HFWDGDGHOLPSODQWH
FRUUHVSRQGHDODSDUWHPHGLDGHODUHJLyQ
JO~WHD $Vt OD SUR\HFFLyQ VHUi PD\RU R
PHQRU GH DFXHUGR FRQ OD HOHFFLyQ GH OD
SUR\HFFLyQGHOLPSODQWH
6HVFDUDFWpULVWLTXHV
6DEDVHRYDOHHWVHVGHX[SURMHFWLRQV
/DSDUWLHODSOXVSURMHWpHGHO¶LPSODQW
FRUUHVSRQG j OD SDUWLH PR\HQQH GH OD
UpJLRQIHVVLqUH'HVRUWHTXHODSURMHFWLRQ
VHUD SOXV RX PRLQV DFFHQWXpH VHORQ OH
FKRL[TXLDXUDpWpIDLWGHODSURMHFWLRQGH
O¶LPSODQW
1266$/,1+$'(,03/$17(6*/Ô7(26
285/,1(2)*/87($/,03/$176
$ 6LOLPHG PDQWpP D PDLV YDULDGD OLQKD
GH LPSODQWHV JO~WHRV GR PHUFDGR FKHLRV FRP
JHO GH VLOLFRQH %LR'HVLJQ GH DOWR GHVHPSHQKR H
FRP D FRQVLVWrQFLD LGHDO SDUD D iUHD GHVWLQDGD
(PERUDWHQKDPVLGRFRQFHELGRVSDUDFLUXUJLDVGH
JOXWHRSODVWLD GH DXPHQWR H UHFRQVWUXomR XQL RX
ELODWHUDOGDUHJLmRJO~WHDHVWHVLPSODQWHVWHPVLGR
XVDGRVFDGDYH]PDLVHPFLUXUJLDVHVWpWLFDVFRP
H[FHOHQWHVUHVXOWDGRV
)RUQHFLGRHVWpULO
6LOLPHG PDLQWDLQV WKH PRVW YDULHG OLQH
RI JOXWHDO LPSODQWV RQ WKH PDUNHW ILOOHG ZLWK
KLJKSHUIRUPDQFH %LRGHVLJQ VLOLFRQH ZLWK DQ
LGHDO FRQVLVWHQF\ IRU WKH LQWHQGHG DUHD $OWKRXJK
FRQFHLYHGE\JOXWHRSODVW\VXUJHRQVIRUXQLRUEL
ODWHUDOUHFRQVWUXFWLRQRUWRLQFUHDVHWRWKHJOXWHDO
DUHDWKHVHLPSODQWVDUHEHLQJXVHGPRUHDQGPRUH
LQFRVPHWLFVXUJHU\ZLWKH[FHOOHQWUHVXOWV
6XSSOLHGVWHULOH
'LIIHUHQWW\SHVDYDLODEOHDVGHVFULEHGEHORZ
$SUHVHQWDGR HP GLIHUHQWHV WLSRV FRQIRUPH
GHVFULWRDVHJXLU
18(675$/Ì1($'(,03/$17(6*/Ô7(26
1275(/,*1('·,03/$176)(66,(56
6LOLPHG PDQWLHQH OD PiV YDULDGD OtQHD GH
LPSODQWHV JO~WHRV GHO PHUFDGR VRQ OOHQDGRV
FRQJHOGHVLOLFRQD%LRGHVLJQGHDOWRGHVHPSHxR\
WLHQHQODFRQVLVWHQFLDLGHDOSDUDHOiUHDGHVWLQDGD
$XQTXH KD\DQ VLGR FRQFHELGRV SDUD FLUXJtDV GH
JOXWHRSODVWLD GH DXPHQWR \ UHFRQVWUXFFLyQ XQL R
ELODWHUDO GH OD UHJLyQ JO~WHD HVWRV LPSODQWHV KDQ
VLGRXVDGRVFDGDYH]PiVHQFLUXJtDVHVWpWLFDVFRQ
H[FHOHQWHVUHVXOWDGRV
6HHQWUHJDHVWpULO
6LOLPHG SRVVqGH OD OLJQH OD SOXV YDULpH
G·LPSODQWV IHVVLHUV GX PDUFKp UHPSOLV GH JHO GH
VLOLFRQH %LRGHVLJQ KDXWHPHQW SHUIRUPDQW HW j
FRQVLVWDQFH LGpDOH SRXU OD UpJLRQ j ODTXHOOHV LOV
VH GHVWLQHQW %LHQ TX·LOV VRLHQW FRQoXV SRXU OHV
FKLUXUJLHV GH JOXWpRSODVWLH G·DXJPHQWDWLRQ HW GH
UHFRQVWUXFWLRQXQLODWpUDOHRXELODWpUDOHGHODUpJLRQ
IHVVLqUHFHVLPSODQWVVRQWGHSOXVHQSOXVXWLOLVpV
DYHF G·H[FHOOHQWV UpVXOWDWV HQ FKLUXUJLH SODVWLTXH
HVWKpWLTXH
)RXUQLVVWpULOLVpV
6H SUHVHQWD HQ GLIHUHQWHV WLSRV FRQIRUPH VH
GHVFULEHDFRQWLQXDFLyQ
([LVWHQWHQGLIIpUHQWVPRGqOHVGpFULWVFLDSUqV
4XDUW]R2YDO
6XSHUItFLHOLVDRSDFD2EWLGDDWUDYpVGH
XPDWHFQRORJLDGLIHUHQFLDGD
4XDUW]R2YDO
6PRRWKRSDTXHVXUIDFH2EWDLQHGIURP
GLIIHUHQWLDWHGWHFKQRORJ\
4XDUW]R2YDO
6XSHUILFLHOLVDRSDFD2EWHQLGDDWUDYpV
GHXQDWHFQRORJtDGLIHUHQFLDGD
4XDUW]R2YDOH
6XSHUILFLH OLVVH RSDTXH 2EWHQXH DX
PR\HQG¶XQHWHFKQRORJLHGLIIpUHQFLpH
3URMHomR%DL[D
/RZ3URMHFWLRQ
3UR\HFFLyQ%DMD
3URMHFWLRQ%DVVH
FP
FP
48$57=2
$
%
&
3URMHomR$OWD
+LJK3URMHFWLRQ
3UR\HFFLyQ$OWD
3URMHFWLRQ+DXWH
FP
FP
48$57=2
$
%
&
*O~WHR5HGRQGR
6XSHUItFLH OLVD EULOKDQWH 'HVHQYROYLGR
HP SDUFHULD FRP 'U -RVp 5REOHV HP
5RXQG*OXWHDO
6PRRWK VKLQ\ VXUIDFH 'HYHORSHG LQ
SDUWQHUVKLSZLWK'U-RVp5REOHVLQ
*O~WHR5HGRQGR
6XSHUILFLH /LVD EULOODQWH 'HVDUUROODGR
MXQWRFRQHO'U-RVp5REOHVHQ
)HVVLHU5RQG
6XSHUILFLH /LVVH EULOODQWH &RQoX HQ
SDUWHQDULDW DYHF OH 'U -RVp 5REOHV HQ
FP
FP
$
%
3DUD LQIRUPDo}HV VREUH QRVVD OLQKD GH JO~WHRV
FRQVXOWHR5HSUHVHQWDQWH6LOLPHG
1RWD 'LPHQV}HV H YROXPHV FRP YDORUHV
DSUR[LPDGRV
)RU LQIRUPDWLRQ DERXW RXU JOXWHDO LPSODQW OLQH
FRQVXOWD6LOLPHG5HSUHVHQWDWLYH
1RWH'LPHQVLRQVDQGYROXPHVJLYHQLQDSSUR[LPDWH
YDOXHV
3DUDLQIRUPDFLRQHVVREUHQXHVWUDOtQHDGHJO~WHRV
FRQVXOWHDO5HSUHVHQWDQWH6LOLPHG
1RWD 'LPHQVLRQHV \ YRO~PHQHV FRQ YDORUHV
DSUR[LPDGRV
3RXU GH SOXV DPSOHV LQIRUPDWLRQV VXU QRWUH
OLJQH GH IHVVLHUV Q¶KpVLWH] SDV j FRQVXOWHU QRWUH
5HSUpVHQWDQW6LOLPHG
1RWH'LPHQVLRQVHWYROXPHVjYDOHXUVDSSURFKpHV
'HYLGR D UHJLmR JO~WHD VHU PXLWR VpSWLFD QmR
UHFRPHQGDPRV R XVR GH PHGLGRUHV 6XJHULPRV D
XWLOL]DomR GH JDEDULWRV TXH DX[LOLDP R FLUXUJLmR QD
DYDOLDomR SUpFLUXUJLFD 'LVSRQtYHLV FRP D IRUPD
GD EDVH GRV LPSODQWHV 1mR VH GHVWLQDP DR XVR
FLU~UJLFR
2ZLQJWRWKHJOXWHDOUHJLRQEHLQJYHU\VHSWLFZHGR
QRW UHFRPPHQG WKH XVH RI PHDVXULQJ GHYLFHV :H
VXJJHVWWKHXVHRIWHPSODWHVZKLFKKHOSWKHVXUJHRQ
LQWKHSUHVXUJLFDOHYDOXDWLRQ$YDLODEOHLQWKHEDVLF
IRUPRIWKHLPSODQWV1RWLQWHQGHGIRUVXUJLFDOXVH
&RPR OD UHJLyQ JO~WHD HV PX\ VpSWLFD QR
UHFRPHQGDPRV HO XVR GH PHGLGRUHV 6XJHULPRV OD
XWLOL]DFLyQ GH SODQWLOODV TXH D\XGDQ DO FLUXMDQR HQ OD
HYDOXDFLyQ SUHTXLU~UJLFD 'LVSRQLEOHV FRQ OD IRUPD
GH OD EDVH GH ORV LPSODQWHV1R VH GHVWLQDQ D XVR
TXLU~UJLFR
/D UpJLRQ IHVVLqUH pWDQW WUqV VHSWLTXH QRXV QH
UHFRPPDQGRQV SDV O·XVDJH GH FDOLEUHV 1RXV
VXJJpURQV GH UHFRXULU j GHV JDEDULWV TXL DLGHQW OH
FKLUXUJLHQjHIIHFWXHUVRQpYDOXDWLRQSUpFKLUXUJLFDOH
,OV VRQW GLVSRQLEOHV GDQV OD IRUPH GH OD EDVH GH
O·LPSODQW ,OV QH VRQW SDV GHVWLQpV i XQ XVDJH
FKLUXUJLFDO
,03/$17(6'(3$17855,/+$
&$/),03/$176
(VWHV LPSODQWHV VmR LQGLFDGRV SDUD FLUXUJLDV
HVWpWLFDV H UHSDUDGRUDV GD SHUQD WDLV FRPR
VHTHODV GH SROLRPLHOLWH PDOIRUPDomR FRQJrQLWD
DIHFo}HVQHXUROyJLFDVWUDXPDWLVPRHRXWURV
&RQVWLWXtGR GH XPD PHPEUDQD GH HODVW{PHUR
GH VLOLFRQH FRQWpP XP YROXPH GHILQLGR GH
JHO GH VLOLFRQH %LRGHVLJQ GH DOWR GHVHPSHQKR
GHVHQYROYLGRGHPRGRTXHDVXDIRUPDGHQVLGDGH
H FRQVLVWrQFLD VHMDP VLPLODUHV DR WHFLGR
KXPDQRVHQGRLQGLFDGRSDUDDSOLFDomRHPFLUXUJLDV
HVWpWLFDVRXUHFRQVWUXWRUDV
7KHVHLPSODQWVDUHLQGLFDWHGIRUDHVWKHWLFDQG
UHSDUDWRU\VXUJHU\RIWKHOHJVXFKDVVHTXHODHRI
SROLRP\HOLWLVFRQJHQLWDOPDOIRUPDWLRQQHXURORJLFDO
GLVRUGHUVWUDXPDWLVPDQGRWKHUV
0DGH RI D VLOLFRQH HODVWRPHU HQYHORSH WKH
LPSODQW FRQWDLQV D GHILQHG YROXPH RI KLJKO\
UHVLVWDQWKLJKSHUIRUPDQFH%LRGHVLJQVLOLFRQHJHO
GHYHORSHGLQVXFKDZD\WKDWLWVVKDSHGHQVLW\DQG
FRQVLVWHQF\DUHVLPLODUWRKXPDQWLVVXHLQGLFDWHG
IRU DSSOLFDWLRQ LQ DHVWKHWLF RU UHFRQVWUXFWLYH
VXUJHU\
)RUQHFLGRV HVWpUHLV $SUHVHQWDPVH HP
GLIHUHQWHVWLSRVFRQIRUPHGHVFULWRDEDL[R
6XSSOLHGVWHULOH3UHVHQWHGLQVHYHUDOW\SHVDV
GHVFULEHGEHORZ
,03/$17(6'(3$17255,//$
,03/$176'(02//(7
(VWRV LPSODQWHV VH LQGLFDQ SDUD FLUXJtDV
HVWpWLFDV \ UHSDUDGRUDV GH OD SLHUQD WDOHV FRPR
VHFXHODV GH SROLRPLHOLWLV PDOIRUPDFLyQ FRQJpQLWD
DIHFFLRQHVQHXUROyJLFDV\WUDXPDWLVPRHQWUHRWURV
(VWi FRQVWLWXLGR SRU XQD PHPEUDQD GH
HODVWyPHUR GH VLOLFRQD FRQWLHQH XQ YROXPHQ
GHILQLGR GH JHO GH VLOLFRQD %LRGHVLJQ GH DOWR
GHVHPSHxR GHVDUUROODGR GH WDO PRGR TXH VX
IRUPD GHQVLGDG \ FRQVLVWHQFLD VHDQ VLPLODUHV DO
WHMLGR KXPDQR \ VH LQGLFDQ SDUD XVR HQ FLUXJtDV
HVWpWLFDVRUHFRQVWUXFWRUDV
&HVLPSODQWVVRQWLQGLTXpVSRXUOHVFKLUXUJLHV
HVWKpWLTXHVHWUpSDUDWULFHVGHODMDPEHWHOOHVTXH
VpTXHOOHVGHSROLRP\pOLWHPDOIRUPDWLRQFRQJpQLWDOH
DIIHFWLRQVQHXURORJLTXHVWUDXPDWLVPHVHWDXWUHV
&RQVWLWXpV G·XQH HQYHORSSH G·pODVWRPqUH GH
VLOLFRQH LOV FRQWLHQQHQW XQ YROXPH GpILQL GH JHO
GH VLOLFRQH %LRGHVLJQ KDXWHPHQW SHUIRUPDQW
GpYHORSSp GH PDQLqUH TXH OHXU IRUPH OHXU
GHQVLWp HW OHXU FRQVLVWDQFH VRLHQW VLPLODLUHV j
FHOOHV GX WLVVX KXPDLQ FH TXL UHQG FHV LPSODQWV
SDUWLFXOLqUHPHQWDSSOLFDEOHVHQFKLUXUJLHHVWKpWLTXH
RXUHFRQVWUXFWULFH
(QWUHJDGR HVWpULOHV 3UHVHQWDGRV HQ YDULRV
WLSRVFRPRGHVFULWRVDEDMR
)RXUQLV VWpULOLVpV LOV VRQW SUpVHQWpV VRXV
GLIIpUHQWVPRGqOHVFRPPHLOHVWGpFULWFLDSUqV
6XSHUItFLH/LVD%DVH$VVLPpWULFD
'HVHQKDGR SDUD VH DSUR[LPDU PDLV j
DQDWRPLDGDUHJLmRWRUQDQGRGHVQHFHV
ViULRRXVRGHYiULRVLPSODQWHV
6PRRWK6XUIDFH$V\PPHWULFDO%DVH
'HVLJQHGWRJHWFORVHUWRWKHDQDWRP\RI
WKHDUHDWKXVPDNLQJWKHXVHRIVHYHUDO
LPSODQWVXQQHFHVVDU\
'HVHQYROYLGR HP SDUFHULD FRP R 'U
0RQWHOODQRHP
'HYHORSHGLQSDUWQHUVKLSZLWK'U0RQWHOODQR
LQ
6XSHUILFLH/LVD%DVH$VLPpWULFD
'LVHxDGR SDUD DSUR[LPDUVH PiV GH OD
DQDWRPtD GH OD UHJLyQ KDFLpQGRVH DVt
LQQHFHVDULRHOXVRGHYDULRVLPSODQWHV
6XSHUILFLH/LVVH%DVH$V\PpWULTXH
'HVVLQp DILQ GH VH UDSSURFKHU OH SOXV
SRVVLEOH GH O¶DQDWRPLH GH OD UpJLRQ LO
UHQG LQXWLOH OH UHFRXUV j GHV LPSODQWV
GLVWLQFWV
'HVDUUROODGR MXQWR FRQ HO 'U 0RQWHOODQR HQ
&RQoX HQ SDUWHQDULDW DYHF OH 'U 0RQWHOODQR
HQ
FP
FP
$
%
&
6XSHUItFLH/LVD%DVH6LPpWULFD
'HVHQKDGR FRPR GL] R QRPH FRP
EDVH VLPpWULFD R TXH SHUPLWH R XVR GH
YiULRV LPSODQWHV DR PHVPR WHPSR SDUD
REWHQomRGRUHOHYRGHVHMDGR
6PRRWK6XUIDFH6\PPHWULFDO%DVH
'HVLJQHG DFFRUGLQJ WR LWV QDPH ZLWK D
V\PPHWULFDO EDVH ZKLFK DOORZV WKH XVH
RI VHYHUDO LPSODQWV DW WKH VDPH WLPH LQ
RUGHUWRDFKLHYHWKHGHVLUHGUHOLHI
'HVHQYROYLGR HP SDUFHULD FRP R 'U
*OLFHQVWHLQHP
'HYHORSHG LQ SDUWQHUVKLS ZLWK 'U *OLFHQVWHLQ
LQ
6XSHUILFLH/LVD%DVH6LPpWULFD
'LVHxDGR FRPR GLFH HO QRPEUH FRQ
EDVH VLPpWULFD OR TXH SHUPLWH HO XVR GH
YDULRVLPSODQWHVDOPLVPRWLHPSRKDVWD
FRPSOHWDUHOUHOLHYHGHVHDGR
6XSHUILFLH/LVVH%DVH6\PpWULTXH
'HVVLQpFRPPHVRQQRPO¶LQGLTXHDYHF
XQH EDVH V\PpWULTXH FH TXL SHUPHW
GH UHFRXULU j GLYHUV LPSODQWV HQ PrPH
WHPSVDILQG¶REWHQLUOHUHOLHIVRXKDLWp
&RQoXHQSDUWHQDULDWDYHFOH'U*OLFHQVWHLQHQ
'HVDUUROODGR MXQWR FRQ HO 'U *OLFHQVWHLQ HQ
FP
FP
1RWD 'LPHQV}HV
DSUR[LPDGRV
H
$
YROXPHV
FRP
%
&
1RWH 'LPHQVLRQV DQG YROXPHV ZLWK DSSUR[LPDWH
YDOXHV
YDORUHV
1RWD 'LPHQVLRQHV \ YRO~PHQHV FRQ YDORUHV
DSUR[LPDGRV
1RWH'LPHQVLRQVHWYROXPHVjYDOHXUVDSSURFKpHV
$ 6,/,0(' RIHUHFH PHGLGRUHV GH SDQWXULOOKD SDUD
DX[LOLDURFLUXUJLmRQDDYDOLDomRGRWDPDQKRGRLPSODQWH
D VHU XWLOL]DGR 6mR LQVWUXPHQWRV GH FRU GLIHUHQWH GR
LPSODQWH SRUpP FRP DV PHVPDV FDUDFWHUtVWLFDV GH
EDVH H WDPDQKR GRV LPSODQWHV UHDLV $V UHIHUrQFLDV
VmRDVPHVPDVGHQRVVRVSURGXWRVDFUHVFLGDVGDOHWUD
0([5()0
6,/,0(' RIIHUV FDOI VL]HUV WR KHOS WKH VXUJHRQ
HYDOXDWHWKHVL]HRIWKHLPSODQWWREHXVHG7KHVHDUH
LQVWUXPHQWV RI D GLIIHUHQW FRORU WKDQ WKH LPSODQW EXW
KDYHWKHVDPHFKDUDFWHULVWLFVDVWKHUHDOLPSODQWVDV
UHJDUGVWKHEDVHDQGVL]H7KHUHIHUHQFHVDUHWKHVDPH
DVIRURXUSURGXFWVZLWKWKHDGGLWLRQRIWKHOHWWHU0IRU
H[DPSOH5()0
6,/,0('RIUHFHPHGLGRUHVGHSDQWRUULOODSDUDDX[LOLDU
DO FLUXMDQR D HYDOXDU HO WDPDxR GHO LPSODQWH TXH VHUi
XWLOL]DGR6RQLQVWUXPHQWRVFRQXQFRORUGLIHUHQWHSHUR
FRQ ODV PLVPDV FDUDFWHUtVWLFDV GH EDVH \ WDPDxR GH
ORV LPSODQWHV UHDOHV /DV UHIHUHQFLDV VRQ ODV PLVPDV
GHQXHVWURVSURGXFWRVPiVODOHWUD0([5()
0
6,/,0(' RIIUH GHV FDOLEUHV GH PROOHW DILQ G·DLGHU OH
FKLUXUJLHQ j pYDOXHU OD WDLOOH GH O·LPSODQW j XWLOLVHU ,O
V·DJLW G·LQVWUXPHQWV GH FRXOHXU GLIIpUHQWH GH FHOOH GH
O·LPSODQWPDLVSRVVpGDQWOHVPrPHVFDUDFWpULVWLTXHV
GHEDVHHWGHWDLOOHGHVLPSODQWVUpHOV/HVUpIpUHQFHV
VRQWOHVPrPHVTXHFHOOHVGHQRVSURGXLWVVXLYLHVGH
ODOHWWUH0([5()0
,03257$17( 2V,PSODQWHVGH3DQWXUULOKDSRVVXHP
XPD´EROVLQKDµGHVLOLFRQHHPXPDGDVH[WUHPLGDGHV
GH VXD EDVH SDUD DX[LOLDU QD VXD LQWURGXomR (VIRUoR
H[FHVVLYR HRX R XVR GH LQVWUXPHQWRV SRQWLDJXGRV
SRGHP OHYDU DR URPSLPHQWR GR SURGXWR HRX GHVWD
´EROVLQKDµ)LJ
,03257$17 &DOI ,PSODQWV KDYH D ´VPDOO LQVHUWLRQ
SRXFKµ PDGH RI VLOLFRQH DWWDFKHG WR RQH RI WKH HQGV
RI WKH EDVH WR KHOS WKH LQVHUWLRQ 7R DYRLG GDPDJLQJ
WKHLPSODQWVGRQRWXVHDQ\VKDUSLQVWUXPHQWV)LJ
,03257$17( /RV ,PSODQWHV GH 3DQWRUULOOD WLHQHQ
HQ XQD GH ODV H[WUHPLGDGHV GH VX EDVH XQD ´EROVLWDµ
GH VLOLFRQD SDUD DX[LOLDU VX LQWURGXFFLyQ (VIXHU]R
H[FHVLYR \R HO XVR GH LQVWUXPHQWRV SXQWLDJXGRV
SXHGHQURPSHUHOSURGXFWR\RHVWD´EROVLWDµ)LJ
,03257$17 /HV ,PSODQWV GH 0ROOHW VRQW pTXLSpV
G·XQH ´SRFKHWWHµ GH VLOLFRQH j O·XQH GHV H[WUpPLWpV
GHOHXUEDVHDILQG·HQIDFLOLWHUO·LQWURGXFWLRQ8QHIIRUW
H[FHVVLIHWRXO·HPSORLG·LQVWUXPHQWVSRLQWXVSHXYHQW
FDXVHU OD UXSWXUH GX SURGXLW HWRX GH OD ´SRFKHWWHµ
)LJ
)LJ
,03/$17(3(,725$/
3(&725$/,03/$17
6LOLPHG SLRQHLUD QD IDEULFDomR GH
,PSODQWHV 3HLWRUDLV GHVHQYROYLGRV HP
SDUFHULDFRP'U*DU\+RUQHGLVSRQtYHO
GHVGHRLQtFLRGDGpFDGDGH
6LOLPHG LV D SLRQHHU LQ PDQXIDFWXULQJ
3HFWRUDO ,PSODQWV GHYHORSHG LQ
SDUWQHUVKLS ZLWK 'U *DU\ +RUQ DQG
DYDLODEOHVLQFHWKHHDUO\V
,03/$17(3(&725$/
,03/$173(&725$/
6LOLPHG SLRQHUD HQ OD IDEULFDFLyQ GH
,PSODQWHV3HFWRUDOHVGHVDUUROODGRVMXQWR
FRQHO'U*DU\+RUQ\GLVSRQLEOHVGHVGH
ORVLQLFLRVGHORV
6LOLPHG SLRQQLHU GDQV OD IDEULFDWLRQ
G¶,PSODQWV 3HFWRUDX[ FRQoXV HQ
SDUWHQDULDW DYHF OH 'U *DU\ +RUQ HW
GLVSRQLEOHVVXUOHPDUFKpGHSXLVOHGpEXW
GHODGpFHQQLH
3URGX]LQGR LPSODQWHV SHLWRUDLV GHVGH RV
DQRV D 6,/,0(' WHP VHPSUH DFRPSDQKDGR
RV DYDQoRV WHFQROyJLFRV SDUD PHOKRU DWHQGHU jV
QHFHVVLGDGHV FOtQLFDV H HVWpWLFDV GRV SDFLHQWHV
'HVWLQDGRV D UHDOoDU D DSDUrQFLD HVWpWLFD HP
SDFLHQWHVTXHWHPSHLWRSRXFRGHVHQYROYLGRVHP
D SURSRUomR GHVHMDGD IRUDP GHVHQYROYLGRV SDUD
FLUXUJLD UHSDUDGRUD HP FDVRV GH GHILFLrQFLD QD
UHJLmRSHLWRUDOWDOFRPRDSODVLDSHLWRUDOFRQJrQLWD
'HYLGRDRVERQVUHVXOWDGRVREWLGRVVmRXWLOL]DGRV
FDGD YH] PDLV HP FLUXUJLDV HVWpWLFDV 2IHUHFHP
XPFRQWRUQRPDLVSURSRUFLRQDOHDSDUrQFLDQDWXUDO
PHVPR FRP RV P~VFXORV IOH[LRQDGRV HRX HP
PRYLPHQWR
)RUQHFLGR(VWpULO
3URGXFLQJ SHFWRUDO LPSODQWV VLQFH WKH V
6,/,0(' KDV DOZD\V DFFRPSDQLHG WHFKQRORJLFDO
DGYDQFHVLQRUGHUWRXQGHUVWDQGEHWWHUWKHSDWLHQW·V
FOLQLFDODQGDHVWKHWLFQHHGV'HVLJQHGWRHQKDQFH
WKH DHVWKHWLF DSSHDUDQFH RI SDWLHQWV ZKRVH
FKHVWVDUHQRWYHU\GHYHORSHGRUODFNWKHGHVLUHG
SURSRUWLRQV WKHVH LPSODQWV ZHUH GHYHORSHG IRU
UHSDUDWRU\ VXUJHU\ LQ WKH SHFWRUDO UHJLRQ VXFK
DV FRQJHQLWDO SHFWRUDO DSODVLD 7KDQNV WR WKH
VDWLVIDFWRU\UHVXOWVREWDLQHGWKH\DUHEHLQJXVHG
PRUH DQG PRUH RIWHQ LQ DHVWKHWLF VXUJHU\ 7KH\
RIIHU D PRUH SURSRUWLRQDO FRQWRXU DQG D QDWXUDO
DSSHDUDQFHHYHQZLWKWKHPXVFOHVIOH[HGDQGRULQ
PRYHPHQW
6XSSOLHGVWHULOH
3URGXFLHQGR LPSODQWHV SHFWRUDOHV GHVGH ORV
DxRV 6,/,0(' VLHPSUH KD DFRPSDxDGR ORV
DYDQFHV WHFQROyJLFRV SDUD DWHQGHU PHMRU ODV
QHFHVLGDGHVFOtQLFDV\HVWpWLFDVGHORVSDFLHQWHV
'HVWLQDGRV D UHDO]DU OD DSDULHQFLD HVWpWLFD HQ
SDFLHQWHVTXHWLHQHHOSHFKRSRFRGHVDUUROODGRVLQ
OD SURSRUFLyQ GHVHDGD IXHURQ GHVDUUROODGRV SDUD
FLUXJtDVUHSDUDGRUDVHQFDVRVGHGHILFLHQFLDHQOD
UHJLyQSHFWRUDOFRPRODDSODVLDSHFWRUDOFRQJpQLWD
'HELGR D ORV EXHQRV UHVXOWDGRV REWHQLGRV VH
XWLOL]DQFDGDYH]PiVHQFLUXJtDVHVWpWLFDV2IUHFHQ
XQ FRQWRUQR PiV SURSRUFLRQDO \ XQD DSDULHQFLD
QDWXUDOLQFOXVLYHFRQORVP~VFXORVIOH[LRQDGRV\R
HQPRYLPLHQWR
6H(QWUHJD(VWpULO
3URGXLVDQW GHV LPSODQWV SHFWRUDX[ GHSXLV
OHV DQQpHV 6,/,0(' GHPHXUH DWWHQWLYH DX[
DYDQFpHV WHFKQRORJLTXHV DILQ GH PLHX[ UpSRQGUH
DX[H[LJHQFHVFOLQLTXHVHWHVWKpWLTXHVGHVSDWLHQWV
'HVWLQpV j UHKDXVVHU O·DSSDUHQFH HVWKpWLTXH GH
SDWLHQWV GRQW OD SRLWULQH HVW SHX GpYHORSSpH HW
GpSRXUYXH GH OD SURSRUWLRQ VRXKDLWpH LOV RQW pWp
DGDSWpV j OD FKLUXUJLH UpSDUDWULFH GDQV OHV FDV
GH GpILFLHQFH GDQV OD UpJLRQ SHFWRUDOH WHOV TXH
O·DSODVLH SHFWRUDOH FRQJpQLWDOH *UkFH DX[ ERQV
UpVXOWDWVREWHQXVLOVVRQWXWLOLVpVGHSOXVHQSOXV
GDQV OHV FKLUXUJLHV SODVWLTXHV HVWKpWLTXHV ,OV
SURFXUHQWXQFRQWRXUSOXVVRXFLHX[GHVSURSRUWLRQV
HW XQH DSSDUHQFH QDWXUHOOH PrPH ORUVTXH OHV
PXVFOHVVRQWIOpFKLVHWRXHQPRXYHPHQW
)RXUQLVVWpULOLVpV
*HOGH6LOLFRQH6XSHUItFLH/LVD
6LOLFRQH*HO6PRRWK6XUIDFH
*HOGH6LOLFRQD6XSHUILFLH/LVD
*HOGH6LOLFRQH6XUIDFH/LVVH
FP
FP
'
$
%
&
(
'
(
'
(
*HOGH6LOLFRQH6XSHUItFLH7H[WXUL]DGD
6LOLFRQH*HO7H[WXUHG6XUIDFH
*HOGH6LOLFRQD6XSHUILFLH7H[WXUL]DGD
*HOGH6LOLFRQH6XUIDFH7H[WXUpH
FP
FP
'
(
'
(
'
(
$
%
&
(ODVW{PHURGH6LOLFRQH
6XSHUItFLH7H[WXUL]DGD
6LOLFRQH(ODVWRPHU
6PRRWK6XUIDFH
(ODVWyPHURGH6LOLFRQD
6XSHUILFLH7H[WXUL]DGD
(ODVWRPqUHGH6LOLFRQH
6XUIDFH7H[WXUpH
FP
FP
'
(
'
(
'
(
$
%
&
1RWD'LPHQV}HVHYROXPHVFRPYDORUHV
DSUR[LPDGRV
1RWD' GLUHLWR( HVTXHUGR
1RWH'LPHQVLRQVDQGYROXPHVZLWKDSSUR[LPDWH
YDOXHV
1RWH' ULJKW( OHIW
1RWD'LPHQVLRQHV\YRO~PHQHVFRQYDORUHV
DSUR[LPDGRV
1RWD' GHUHFKR( L]TXLHUGR
1RWH'LPHQVLRQVHWYROXPHVjYDOHXUV
DSSURFKpHV
1RWH' GURLW( JDXFKH
(QFRQWUDPVHGLVSRQtYHLVJDEDULWRVFRPDIRUPD
GDEDVHGRVLPSODQWHVSHLWRUDLV(VWHVJDEDULWRV
GHVWLQDPVH D DMXGDU R FLUXUJLmR QD DYDOLDomR
SUpFLU~UJLFDDVHOHFLRQDURLPSODQWHTXHPHOKRU
VHDGDSWHDFDGDFDVR
7HPSODWHV DUH DYDLODEOH ZLWK WKH VKDSH RI WKH
EDVH RI WKH SHFWRUDO LPSODQWV 7KHVH WHPSODWHV
DUH PHDQW WR KHOS WKH VXUJHRQ LQ SUHVXUJHU\
HYDOXDWLRQ WR VHOHFW WKH LPSODQW WKDW EHVW VXLWV
HDFKSDUWLFXODUFDVH
6H HQFXHQWUDQ GLVSRQLEOHV SODQWLOODV FX\D IRUPD
HV LJXDO D OD EDVH GH ORV LPSODQWHV SHFWRUDOHV
(VWDV SODQWLOODV WLHQHQ HO REMHWLYR GH D\XGDU DO
FLUXMDQR GXUDQWH OD HYDOXDFLyQ SUHTXLU~UJLFD
D VHOHFFLRQDU HO LPSODQWH TXH VH DGDSWH PHMRU D
FDGDFDVR
'HVJDEDULWVVRQWGLVSRQLEOHVD\DQWODIRUPHGHOD
EDVH GHV LPSODQWV SHFWRUDX[ &HV JDEDULWV VRQW
GHVWLQpVjDLGHUOHFKLUXUJLHQGDQVVRQpYDOXDWLRQ
SUpFKLUXUJLFDOH HQ OXL SHUPHWWDQW GH FKRLVLU
O·LPSODQWOHPLHX[DGDSWpjFKDTXHFDV
,03257$17( &RQWpP UHIRUoR GH SROLpVWHU SDUD
DMXGDUDVXDLQWURGXomR
,03257$17 &RQWDLQV SRO\HVWHU UHLQIRUFHPHQW WR
KHOSLQWKHLQVHUWLRQ
,03257$17( &RQWLHQH UHIXHU]R GH SROLpVWHU SDUD
IDFLOLWDUODLQWURGXFFLyQ
,03257$17&RQWLHQWXQUHQIRUFHPHQWGHSRO\HVWHU
DILQG·HQIDFLOLWHUO·LQWURGXFWLRQ
IBE, s.r.o.
www.silimedimplantaty.sk
[email protected]