WHEN PRECISE PLACEMENT IS CRITICAL
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- Ethelbert Crawford
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1 WHEN PRECISE PLACEMENT IS CRITICAL Stent Positioning System
2 Ostil Pro Stent Positioning System Ostil Pro Stent Positioning System Fcilittes More Accurte Stent Positioning in AO Lesions OSTIAL PRO Stent Positioning System llows esier ssessment of coronry or renl osti, improving the ccurcy of stent positioning in AO lesions: Unique design provides three dimensionl visul nd tctile feedbck Excellent pushbility nd strong pullbck cpbilities Comptible with 6, 7, nd 8 French guiding ctheters OSTIAL PRO Stent Positioning System helps void potentil complictions. Once positioned ginst the ostium, the OSTIAL PRO Stent Positioning System: Helps prevent deep seting of the guide ctheter 1 My decrese risk of dissection by minimizing guide ctheter tip trum Fcilittes precise stent positioning in the ostium to help reduce the risk of distl nd proximl lesion stent deployment nd the need for more costly reinterventions The OSTIAL PRO Stent Positioning System enbles more ccurte stent plcement, which cn help reduce: The length of procedures Fluoroscopy nd rdition exposure Use of contrst (importnt for preserving renl function) References: 1. Fischell TA et l. Initil clinicl experience using n ostil stent positioning system (Ostil Pro) for the ccurte plcement of stents in the tretment of coronry ortoostil lesions. J Invsive Crdiol. 2009;21(2): Kobo O et l. Screening, dignosis, nd tretment of renl rtery stenosis by percutneous trnsluminl renl ngioplsty with stenting. Isr Med Assoc J. 2010;12(3): Zähringer M et l. Sirolimus-eluting versus bre-metl low-profile stent for renl rtery tretment (GREAT Tril): ngiogrphic follow-up fter 6 months nd clinicl outcome up to 2 yers. J Endovsc Ther. 2007;14(4): Chin K. An pproch to ostil lesion mngement. Curr Interv Crdiol Rep. 2001;3(2): Jokhi P, Curzen N. Percutneous coronry intervention of ostil lesions. EuroIntervention. 2009;5(4): Fischell TA et l. A new ostil stent positioning system (Ostil Pro) for the ccurte plcement of stents to tret orto-ostil lesions. Ctheter Crdiovsc Interv. 2008;71(3): Kpln S et l. Unconventionl tretment of orto-ostil instent restenosis with mrked protrusion into the ort. J Crdiovsc Med (Hgerstown). 2008;9(2): Skmoto H et l. Angiogrphic nd clinicl outcomes fter sirolimus-eluting stent implnttion to de novo ostil lesion of the right coronry rtery: retrospective study. Circ J. 2008;72(6): Dishmon DA et l. CRT 2011 bstrct. 10. Wertmn BM et l. Chrcteriztion of complex coronry rtery stenosis morphology by coronry computed tomogrphic ngiogrphy. JACC Crdiovsc Imging. 2009;2(8): Mvromtis K et l. Comprison of outcomes of percutneous coronry intervention of ostil versus nonostil nrrowing of the mjor epicrdil coronry rteries. Am J Crdiol. 2004;94(5):583-7.
3 Ostil Pro Stent Positioning System The Chllenge of Stenting Aorto-Ostil Lesions Aorto-ostil (AO) stenting ccounts for n estimted 5%-7% of coronry interventions 1 nd more thn 90% of renl rtery interventions. 9 AO lesions re more likely to be ssocited with suboptiml ngiogrphic results due to lesion rigidity nd elstic recoil 4, nd hve higher rtes of trget lesion revsculriztion. 5 Conventionl ngiogrphic lndmrks used during stenting of AO lesions re often mbiguous nd/or misleding, mking ccurte stent positioning extremely difficult. 7 In retrospective study of 100 ptients in whom stents were plced using ngiogrphic lndmrks, correct stent positioning ws chieved in only 46% of cses. 9 This device ws ssocited with decresed procedure time, rdition exposure nd reduced use of contrst. 1 Stent Positioning t Aorto-Ostil Sites Stent too distl Stent position correct Stent too proximl Incomplete coverge of the lesion Protrusion my prevent reenggement of vessel ort
4 Step 1 Step 2 Advnce the Stent Pst the Lesion Position Ostil Pro Stent Positioning System t the AO Junction Step 3 Retrct Stent nd Deploy Step 4 Stent Flring Yellow mrker permits positive identifiction nd differentition of the Ostil Pro Stent Positioning System from other wires. Nitinol wire inch wire llows greter pushbility nd strong pullbck cpbilities. NOTE: Plese red full Instructions for Use for more detiled informtion prior to use.
5 Nitinol gold-plted legs llow greter opcifiction to help identify the plne of the ostium. 15 mm leg spn ccommodtes osti. Flexible distl wire The 4 cm distl end is ground down to inches nd het-treted to llow more flexibility to prevent strightening of the guiding ctheter curve, while retining push/pull chrcteristics. Flexible cylinder Longitudinl opening llows use with 6, 7, or 8 French guiding ctheters. 15 mm Cylinder/wire connection Tpered cylinder permits esy pullbck into the guide. Overll length of 127 cm permits use with ny guide tht is 100 cm in length. In Clinicl Study, OSTIAL PRO Stent Positioning System Significntly Incresed the Accurcy of AO Stent Plcement 1 AO stents ccurtely plced (%) % P % n=30 n=30 OSTIAL PRO Current Techniques* System *Historicl controls prior to use of the OSTIAL PRO Stent Positioning System
6 Ordering Informtion Guide Ctheter Comptibility Ctlog Number 3011 French Size Estimted Ctheter ID Effective ID Pckged 5 per box. Essentil Prescribing Informtion OSTIAL PRO Stent Positioning System Indictions For Use The OSTIAL PRO Stent Positioning System is intended for use in ort-ostil procedures to introduce nd position stents nd other interventionl devices within the coronry nd peripherl vsculture. In ddition, the OSTIAL PRO Stent Positioning System is intended to fcilitte the lignment of interventionl devices nd function s n lignment tool. Contrindictions If other interventionl devices re used in conjunction with the OSTIAL PRO Stent Positioning System, refer to specific mnufcturer s product lbeling for intended use, contrindictions nd potentil complictions ssocited with tht device. Wrnings nd Precutions For Single Use Only. Do Not Resterilize. Device is sterile if the pckge is dry, unopened nd undmged. Do not use if the pckge sel is broken. The device must be used prior to the expirtion dte. Discrd device if mishndling hs cused possible dmge or contmintion. It is recommended tht the ptient must hve received therpeutic dosge of Heprin to chieve ACT > 200. If extended procedure is required (greter thn 30 minutes), it is recommended to not lod the OSTIAL PRO Stent Positioning System into the guiding ctheter until it is needed to id in the plcement of the stent. For these procedures, utilize the Front Loding steps for the OSTIAL PRO Stent Positioning System introduction into the guiding ctheter. If the OSTIAL PRO Stent Positioning System feet nd cylinder is dvnced out of the distl end of the guiding ctheter, gently pull on the proximl end of the OSTIAL PRO Stent Positioning System until the cylinder hs retrcted into the distl end of the guiding ctheter leving only the gold-plted feet exposed or retrct both components in the distl end of the guiding ctheter. Never pull bck the OSTIAL PRO Stent Positioning System with gret force. In the event the cylinder nd feet of the OSTIAL PRO Stent Positioning System re dvnced too fr distlly from the tip of the guide cusing the OSTIAL PRO Stent Positioning System to become deriled from the stent delivery system, perform the following steps: Retrct stent delivery system into guiding ctheter. Never retrct OSTIAL PRO Stent Positioning System into guiding ctheter before stent delivery system hs been withdrwn. Retrct OSTIAL PRO Stent Positioning System into guiding ctheter until feet collpse. Re-cross ostil lesion with stent delivery system. Advnce OSTIAL PRO Stent Positioning System until feet pop out. Stent crossing profile must be less thn Ostil Pro Stent Positioning System effective ID to prevent stent or Ostil Pro Stent Positioning System dmge. Potentil Complictions The following complictions cn occur: emboli, hemorrhge, ischemi, vsospsm, nd neurologicl defects including stroke nd deth. Cution Federl (USA) lw restricts this device to sle by or on order of physicin. The third prty trdemrks used herein re trdemrks of their respective owners 6 F 7 F 8 F Merit Medicl Systems, Inc West Merit Prkwy South Jordn, Uth MERIT Merit Medicl EUROPE, MIDDLE EAST AND AFRICA (EMEA) Amerikln 42, 6199 AE Mstricht-Airport The Netherlnds Tel: Free phone for specific country: Austri Belgium (Dutch) (French) Denmrk Frnce Germny Republic of Irelnd Luxembourg Netherlnds Sweden UK Finlnd /A ID
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