Medtronic - CompleteSE

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  • 1. COMPLETE PERFORMANCEORDER INFORMATION NOW APPROVEDSUPERIOR RADIAL FORCE WITHOUT SACRIFICINGComplete SE Vascular Product CodeSC 6 20 LGAtraumatic tipComplete SE Vascular For SFA/PPACONFORMABILITY* Catheter Working LengthDual-deployment handle SELF-EXPANDING STENT SYSTEMLength(F = 80, L = 130) DiameterRADIAL FORCEProduct Code7mm x 100 mm8mm x 80 mm8mm x 100 mm 6.0 5.46 Retractable sheathRadiopaque markers 5.13 5.16 5.08 Mean Radial Force (N) 5.04.61 4.55Stabilizing sheath 4.15 4.0 3.603.62 3.0 2.69 CatheterStentStent Length (mm) Minimum 2.0 WorkingDiameterSheathLength(mm)Size (F) 1.0 2030 406080100 120150 (cm) 0.0 4 SC420LG SC430LG SC440LG 6130 Medtronic CordisBardMedtronicCook Bard Medtronic Cordis Abbottev3 5 SC520LG SC530LG SC540LGSC560LG SC580LG SC5100LGSC5120LG SC5150LG6130 Complete SmartLifeStent CompleteZilverLifeStent Complete SmartAbsolute Protg 6 SC620LG SC640LG SC660LGSC680LGSC6100LGSC6120LG SC6150LG6130SE Control SE 635 SE Control Pro EverFlex 7 SC720LG SC740LG SC760LGSC780LGSC7100LGSC7120LG SC7150LG6130 Testing was performed with a flat-plate crush to 30% of labeled nominal stent diameter. 8 SC820LG SC840LG SC860LGSC880LGSC8100LGSC8120LG SC8150LG6130 9 SC920LG SC940LG SC960LGSC980LG 6130 10 SC1020LG SC1040LGSC1060LG SC1080LG 6130OPTIMISED CELL DESIGN FOR StentStent Length (mm) Minimum Catheter WorkingDiameterSheathKINK RESISTANCE AND FLEXIBILITY * (mm) 203040 6080100 120150Size (F)Length (cm) 4SC420FGSC430FG SC440FG 680 5 SC520FG SC530FG SC540FGSC560FG SC580FG SC5100FGSC5120FG SC5150FG680 6 SC620FG SC640FGSC660FG SC680FG SC6100FGSC6120FG SC6150FG680 7 SC720FG SC740FGSC760FG SC780FG SC7100FGSC7120FG SC7150FG680 8 SC820FG SC840FGSC860FG SC880FG SC8100FGSC8120FG SC8150FG680 9 SC920FG SC940FGSC960FG SC980FG 68010SC1020FG SC1040FGSC1060FG SC1080FG 680Complete UC201300554 EE 2013 Medtronic, Inc. All rights reserved. Not for distribution in the USA . 01/13 The Complete SE stent is MRI conditional. The Complete SE Vascular Self-Expanding Stent System is indicated to improve luminal diameter in symptomatic patients with previously unstented iliac stenosis in the common and external iliac arteries or atherosclerotic lesions of the Superficial Femoral Artery (SFA) or Proximal Popliteal Artery (PPA) with vessel reference diameters between 3.5 mm and 9.0 mm. Warning: Please reference appropriate product Instructions for Use for a list of indications, warnings, precautions and potential adverse eventOffset crown designminimises crown-to-Three different segmentlengths allow consistent Tested in multimode conditions representative ofPerformancecrown interaction while behavior across allthe iliac, superficial femoralwww.medtronicendovascular.com www.medtronic.eu CONTROL. COMMITMENT. CONFIDENCE.bending diameters: and proximal popliteal arteries Invatec S.p.A. INVATEC TechnologyMedtronic, Inc. Medtronic InternationalMedtronic of Canada Ltd. Minimal foreshorteningto substantiate long-term Via Martiri della Libert 7Center GmbH 710 Medtronic Parkway NETrading Srl 99 Hereford Street performance 25030 Roncadelle (BS) ItalyHungerbelstrasse 12a8500 FrauenfeldMinneapolis, MN 55432USARoute du Molliau 31CH-1131 Tolochenaz Brampton, Ontario L6Y 0R3 Canada Excellent flexibilityTel: +39.030.2589311 Switzerland Tel: +1.763.514.4000SwitzerlandTel: +1.905.460.3800Tel: +41.52.2600660 Tel: +41.21.802.7000 Medtronic Latin AmericaMedtronic International Ltd.Medtronic Australasia Pty Ltd.Medtronic Korea Co., Ltd.Medtronic Mediterranean S.A.L. 3750 NW 87th Avenue, Suite 700 49 Changi South Avenue 297 Waterloo Road5F, Sajo BuildingSt. Charles City Center Miami, FL 33178Singapore 486056North Ryde, NSW 21131001 Daechi-dong, Kangnam-ku 6th Floor, Omar Doauk Street USATel: +65.6436.5000Australia Seoul, 135-280 Beirut 2020-0908 Tel: +1.786.709.4200 Tel: +61.29857.9000 KoreaLebanonTel: +82.2.3404.3600 Tel: +961.1.370670* Test data on file at Medtronic, Inc. Benchtop data may not be indicative of clinical performance. Innovating for life.

2. COMPLETE CONTROLCOMPLETE COMMITMENT COMPLETE CONFIDENCEDEPLOYMENT AND ACCURACY MADE EASY APPROVED FOR ILIAC ARTERY, SFA AND PPAFEWEST REINTERVENTIONS IN THE SFA*TLR rateThe Complete SE 6 F delivery systems unique design incorporates a dualdeployment handle and a triaxial catheter. The dual deployment handle isMedtronic and physicians alike are committed to improving patients lives. We pursuethis mission, in part, by arming healthcare providers with clinical data they need toAn independently adjudicated single-arm multicenter trial evaluatedthe performance of Complete SE for the treatment of atherosclerotic8.4%practice evidence-centered medicine. Complete SE embodies this commitment with lesions of the superficial femoral and proximal popliteal arteries. A at 12 monthsintuitive and easy to use, giving you the ultimate control during deploymentcontinued follow-up in clinical trials that capture the devices safety and efficacy in the representative population comprised of 196 subjects was enrolledwhile the triaxial catheter minimises unexpected jumping.*iliac, superficial femoral and proximal popliteal arteries. with results compared with VIVA Performance Goals.PATIENT DEMOGRAPHICS N = 196%Age 68.7 10.5Male63.3Diabetes mellitus 45.4Dyslipidemia79.6Hypertension90.3History of tobacco use79.6History of CAD62.8History of COPD 21.4Previous MI 26.2Dual Deployment Handle*LESION MORPHOLOGY1% (m/n)3Total lesion length (n = 213)2 (mm) 60.7 37.62 1.otate the handle to retractR 2. Once the stent is properly Total occlusion 29.9(60/201)the sheath slowly andpositioned, complete theallow the stent to expanddeployment by simply Distal SFA/PPA49.7(106/213)in a precisely controlledpushing the buttons andISIS-SE Study Complete SE Iliac RegistryComplete SE SFA Study Mid SFA 34.3(73/213)manner. pulling back the handle in one fluid motion.Proximal SFA16.0(34/213) Calcification12-month MAE 3.3% 9-month MAE9.4% 12-month MAE11.0%Severe56.2(118/210)TVR2.1% TVR9.4% TVR 11.0% Moderate34.8(73/210)Triaxial Catheter TLR2.1% TLR3.8% TLR8.4% None/mild9.0(19/210) The delivery systems triaxial design includes an inner shaft, (n = 158) (n = 55)(n = 196) a retractable sheath and a stabilising sheath. BINARY TRIAL ENDPOINT %MAE at 12 months11.0 Retractable sheath 20022005 2011TVR 11.0TLR8.4 Inner shaftPRIMARY EFFICACY ENDPOINT*ompared with SFA studies of Cook Zilver PTX, IDEV SUPERA,CCordis Smart Stent, Bard Lifestent and EV3 Protg Everflex.Primary patency (PSVR2.0)72.6 The stabilising sheath reduces friction and allows the retractable sheath to move back freely. This Rocha-Singh K et al. Catheter Cardiovasc Interv. 2007;69:910-919. decreases the amount of force required to deploy the stent, making deployment easy and accurate. Reference Complete SE SFA Study - Clinically Driven TLR rate.1 Independently adjudicated by core lab.*est data on file at Medtronic, Inc. Benchtop data may not be indicative of clinical performance.T2 Lesions as reported by the Angiographic Core Laboratory. Data on file3 Based on number of lesions with available data. 3. COMPLETE CONTROLCOMPLETE COMMITMENT COMPLETE CONFIDENCEDEPLOYMENT AND ACCURACY MADE EASY APPROVED FOR ILIAC ARTERY, SFA AND PPAFEWEST REINTERVENTIONS IN THE SFA*TLR rateThe Complete SE 6 F delivery systems unique design incorporates a dualdeployment handle and a triaxial catheter. The dual deployment handle isMedtronic and physicians alike are committed to improving patients lives. We pursuethis mission, in part, by arming healthcare providers with clinical data they need toAn independently adjudicated single-arm multicenter trial evaluatedthe performance of Complete SE for the treatment of atherosclerotic8.4%practice evidence-centered medicine. Complete SE embodies this commitment with lesions of the superficial femoral and proximal popliteal arteries. A at 12 monthsintuitive and easy to use, giving you the ultimate control during deploymentcontinued follow-up in clinical trials that capture the devices safety and efficacy in the representative population comprised of 196 subjects was enrolledwhile the triaxial catheter minimises unexpected jumping.*iliac, superficial femoral and proximal popliteal arteries. with results compared with VIVA Performance Goals.PATIENT DEMOGRAPHICS N = 196%Age 68.7 10.5Male63.3Diabetes mellitus 45.4Dyslipidemia79.6Hypertension90.3History of tobacco use79.6History of CAD62.8History of COPD 21.4Previous MI 26.2Dual Deployment Handle*LESION MORPHOLOGY1% (m/n)3Total lesion length (n = 213)2 (mm) 60.7 37.62 1.otate the handle to retractR 2. Once the stent is properly Total occlusion 29.9(60/201)the sheath slowly andpositioned, complete theallow the stent to expanddeployment by simply Distal SFA/PPA49.7(106/213)in a precisely controlledpushing the buttons andISIS-SE Study Complete SE Iliac RegistryComplete SE SFA Study Mid SFA 34.3(73/213)manner. pulling back the handle in one fluid motion.Proximal SFA16.0(34/213) Calcification12-month MAE 3.3% 9-month MAE9.4% 12-month MAE11.0%Severe56.2(118/210)TVR2.1% TVR9.4% TVR 11.0% Moderate34.8(73/210)Triaxial Catheter TLR2.1% TLR3.8% TLR8.4% None/mild9.0(19/210) The delivery systems triaxial design includes an inner shaft, (n = 158) (n = 55)(n = 196) a retractable sheath and a stabilising sheath. BINARY TRIAL ENDPOINT %MAE at 12 months11.0 Retractable sheath 20022005 2011TVR 11.0TLR8.4 Inner shaftPRIMARY EFFICACY ENDPOINT*ompared with SFA studies of Cook Zilver PTX, IDEV SUPERA,CCordis Smart Stent, Bard Lifestent and EV3 Protg Everflex.Primary patency (PSVR2.0)72.6 The stabilising sheath reduces friction and allows the retractable sheath to move back freely. This Rocha-Singh K et al. Catheter Cardiovasc Interv. 2007;69:910-919. decreases the amount of force required to deploy the stent, making deployment easy and accurate. Reference Complete SE SFA Study - Clinically Driven TLR rate.1 Independently adjudicated by core lab.*est data on file at Medtronic, Inc. Benchtop data may not be indic