DEMAND RESULTS. TRUST ENDURANT.

Transcription

1 DEMAND RESULTS. TRUST ENDURANT. Edurat ll AAA Stet System Edurat IIs AAA Stet System

2 THE ENDURANT II SYSTEM FAMILY OF PRODUCTS Icludes Edurat II, Edurat II AUI ad Edurat IIs stets. Desiged to meet a wide rage of patiet aatomies Utilizes the Edurat II delivery system allowig for accurate placemet ad cotrolled deploymet ENDURANT IIs SYSTEM A three-piece system that leverages the prove desig of the Edurat II abdomial stet graft. Edurat IIs system expads aatomical customizatio optios Provides up to a 20% reductio i distal diameter compared to select Edurat II stet bifurs * Eables i situ sizig with select ipsilateral limbs, allowig a 3 5 stet overlap for adjustmet durig case Allows easier pre-case plaig to simplify sizig Edurat IIs stet graft Edurat II AUI stet graft The oly device with a FDA-approved AUI idicatio Edurat II stet graft * Data o file at Medtroic. Edurat II/IIs system Istructios for Use As of May

3 ENDURANT II SYSTEM PRODUCT FEATURES A. Flexibility & Coformability Desiged to coform to the atural tortuosity of the vessel Low profile, hydrophilic delivery coatig to ehace access ad trackability B. Accurate Placemet & Cotrolled Deploymet Flexible, kik-resistat delivery system facilitates stet graft delivery Tip capture for precise positioig adjustmets, icludig adjustmet of placemet proximally or distally C. Optimal Seal & Fixatio M-shaped proximal stets provide wall appositio ad miimize i-foldig Suprareal stet achor pis provide secure fixatio D. Durability & Stregth High desity, multifilamet polyester graft material provides lower porosity for resistace agaist aeurysm sac growth A C B D Bech test data o file at Medtroic. Bech test data may ot be idicative of cliical performace. 3

4 OVER 15 YEARS OF ENDOVASCULAR ACHIEVEMENT. NOVEL MULTIDISCIPLINARY APPROACH TO OPTIMIZE KEY ATTRIBUTES Physicias Iterviewed Computatioal Modelig Imagig Aalysis Bech Testig Edurat EU Study Edurat US IDE ENGAGE ATTRIBUTES Sealig Durability Optimized Coformability i for Results Tortuous Aatomies Fixatio Delivery System Performace PERFORMANCE Expaded Applicability of EVAR Short, Agulated Proximal Necks Coform to Challegig Aatomy Trackability through Tortuous Aatomy Expaded Patiet Customizatio Optios Compatible with Aptus EdoAchor System 45 agle achor pis desiged to maximize migratio resistace force 10 mm M stet desiged for optimal seal 30 mm Modified M stet desiged for optimal flexibility Treat ecks as short as 10mm ad agulatio up to 60 Edurat system has uparalleled cliical experiece with over 250,000 patiets. * Iterdiscipliary ad Traslatioal Iovatio: The Edurat Stet From Bedside to Bechtop ad Back to Bedside Frak R. Arko, MD1; William D. Jorda, Jr., MD2; Sam Robaia, MS3; M. Zachary Arko4; Thomas J. Fogarty, MD5; Michel S. Makarou, MD6; ad Hece J.M. Verhage, MD, J ENDOVASC THER 2011;18:

5 PRE 0% POST Type I Edoleak at 5 years 0% Migratio at 5 years Pre-procedure ad oe-moth follow-up of Edurat AAA stet graft. Results may vary Edurat system Cliical Update Proximal migratio is observed whe the stet graft covers a real artery or moves > 10 mm. migratio is observed whe the graft moves > 10 mm relative to fixed aatomic ladmarks Edurat system Cliical Update. 5

6 CONSISTENT PRECISION CONTROLLED DEPLOYMENT 100% PEVAR delivery/ deploymet success * A backed thumb wheel provides cotrolled release of the suprareal stet ad achor pis. Tip capture for precise positioig adjustmets, icludig adjustmet of placemet proximally or distally, eve after deploymet of three stet rigs. * Data o file from the 178 De Novo patiets from the ENGAGE Post-Approval Study (PAS). Please refer to the product Istructios For Use for details. 6

7 A advaced delivery system makes the Edurat II stet graft simple to place. With cotrol at every step, you ca approach more targets with cofidece. 99.3% delivery/ deploymet success Aim accurately with four proximal markers Easy cotralateral limb placemet with the flow divider marker Facilitate gate caulatio with improved radiopacity of cotralateral gate marker e-shaped marker assists with A/P orietatio Delivery success = successful vascular access ad delivery of the device to the iteded aatomical treatmet site. Deploymet success = successful deploymet of the device i the iteded site ad the successful removal of the delivery system. Edurat US IDE trial: Makarou M. Oe-year outcomes of the US regulatory trial of the Edurat stet graft system. J Vasc Surg. 2011; 54:

8 INCOMPARABLE CLINICAL EXPERIENCE Erolled ad plaed AAA patiets * Medtroic Gore Edologix/ Cook Cordis Trivascular Medtroic Edurat II (N=1895) EU TRIAL 1yr N=80 Frace Post Approval 3yrs N=180 US Post Approval 4yrs N=178 ENGAGE Global Registry 4yrs N=1263 US IDE AUI Arm 5yrs N=44 US IDE Bifurcated Arm 5yrs N=150 Oly Edurat system has the deep cliical experiece ad favorable cliical outcomes desiged to treat both challegig ad straightforward aatomy. Edurat system is the device of choice globally, 1 out of 2 EVAR devices used is a Edurat system. * Medtroic data o file. Third-party trademarks foud i this literature are property of their respective owers. Edologix = 2934, Trivascular = 1622 Medtroic data o file. Curret as of September

9 THERE IS NO NEED TO COMPROMISE ON CLINICAL RESULTS ENGAGE Registry 4-year results, =1,263 US IDE Trial 1 5-Year results, =150 CLINICAL ENDPOINTS RESULTS RESULTS Coversio 1.1% 0% Type I/III Edoleak 2.2% 0% Migratio (mai body) 0.1% 0% Sac size decrease or stable 89.2% 95.2% Aeurysm Related Mortality 98.3% (FF) Secodary Procedure 87.1% (FF) 99.2% (FF) 89% (FF) The Edurat stet graft system 5 Year Log-Term Outcomes Reiforced i Idepedet PANDORA Registry All-comer patiet populatio 49% eck legths 10mm to <15mm 7% symptomatic patiets 2% cotaied ruptured aeurysm No exclusio criteria PANDORA Registry, 2 5 Year Results, N=277 patiets AAA-related Reitervetio 9.5% Type I/III Edoleak 2% Migratio (proximal) 0% AAA-related Mortality 0.3% Verhage, Hece. VEITH Medtroic database 1 Sigh, Michael. SVS 2015/ Edurat US IDE. Medtroic database 2 Torsello, Giovai. Charig Cross 2014 Presetatio. 9

10 COMPONENT PLACEMENT GUIDE ENDURANT II STENT GRAFT ENDURANT IIs STENT GRAFT 23, 25, 28, 32, 36 mm AORTIC EXTENSION MARKERS 23, 25, 28, 32, 36 mm BIFURCATED MARKERS 23, 25, 28, 32, 36 mm BIFURCATED MARKERS AORTIC EXTENSION 3 49, 70 mm 23, 25, 28, 32, 36 mm 10, 13, 20, 24, 28 mm ILIAC EXTENSION MARKERS BIFURCATED GRAFT 124 *, 145, 166 mm 12, 14 mm 16 mm LIMBS MARKERS 1 LIMBS 82, 93, 124, 156, 199 mm AUI MARKERS BIFURCATED GRAFT 103mm LIMBS MARKERS 1 16 mm 14 mm 14 mm 16 mm LIMBS MARKERS 1 LIMBS 82, 93, 124, 156, 199 mm 23, 25, 28, 32, 36 mm ILIAC EXTENSION 3 82 mm 13, 16, 20 mm 10, 13, 16, 20, 24, 28 mm 10, 13, 16, 20, 24, 28 mm 10, 13, 16, 20, 24, 28 mm 10, 13, 20, 24, 28 mm DISTINCT RADIOPAQUE MARKERS Radiopaque markers e-shaped proximal markers Iteral rig marker oly see uder fluoroscopy 1 The limb mates with the AUI stet graft o the ipsilateral side. 2 The 3-5 stet overlap is available oly with select limbs. Please refer to the Istructios for Use for more iformatio. 3 Requires miimum 3 stet overlap. See Istructios for Use for more iformatio. 4 As of May differet mai body ad limb combiatios 14 mm AUI GRAFT mm 4,500 differet mai body ad limb combiatios The oly device with a FDA-approved AUI idicatio 4 10

11 PRODUCT CODES ENDURANT II SYSTEM BIFURCATIONS Proximal Product Code Desig Legth Delivery System Catheter Outer (F) ETBF C 124 E 18 ETBF C 145 E 18 ETBF C 166 E 18 ETBF C 124 E 18 ETBF C 145 E 18 ETBF C 166 E 18 ETBF C 124 E 18 ETBF C 145 E 18 ETBF C 166 E 18 ETBF C 124 E 18 ETBF C 145 E 18 ETBF C 166 E 18 ETBF C 124 E 18 ETBF C 145 E 18 ETBF C 166 E 18 ETBF C 124 E 18 ETBF C 145 E 18 ETBF C 166 E 18 ETBF C 124 E 18 ETBF C 145 E 18 ETBF C 166 E 18 ETBF C 124 E 20 ETBF C 145 E 20 ETBF C 166 E 20 ETBF C 124 E 20 ETBF C 145 E 20 ETBF C 166 E 20 ETBF C 145 E 20 ETBF C 166 E 20 ETBF C 145 E 20 ETBF C 166 E 20 ENDURANT IIs SYSTEM BIFURCATIONS Proximal Product Code Desig Legth Delivery System Catheter Outer (F) ESBF C 103 E 18 ESBF C 103 E 18 ESBF C 103 E 18 ESBF C 103 E 20 ESBF C 103 E 20 AORTIC EXTENSIONS Proximal Product Code Desig Legth Delivery System Catheter Outer (F) ETCF C 49 E 18 ETCF C 49 E 18 ETCF C 49 E 18 ETCF C 49 E 20 ETCF C 49 E 20 ETTF C 70 E 18 ETTF C 70 E 18 ETTF C 70 E 18 ETTF C 70 E 20 ETTF C 70 E 20 LIMBS* Proximal Product Code Desig Delivery Legth System Catheter Outer (F) Cotralateral Legth with EII/EIIs Bifurcated Ipsilateral Legth with EIIs Bifurcated ETLW C 82 E ETLW C 93 E ETLW C 124 E ETLW C 156 E ETLW C 199 E ETLW C 82 E ETLW C 93 E ETLW C 124 E ETLW C 156 E ETLW C 199 E ETLW C 82 E ETLW C 93 E ETLW C 124 E ETLW C 156 E ETLW C 199 E ETLW C 82 E ETLW C 93 E ETLW C 124 E ETLW C 156 E ETLW C 199 E ETLW C 82 E ETLW C 93 E ETLW C 124 E ETLW C 156 E ETLW C 199 E ETLW C 82 E ETLW C 93 E ETLW C 124 E ETLW C 156 E ETLW C 199 E * The limb mates with the AUI stet graft o the ipsilateral side. These calculatios assume the miimum 30 mm overlap betwee the bifurcated stet graft ad the cotralateral iliac limb per the Edurat II Stet System Istructios For Use. Whe usig the 124 mm legth bifurcated stet graft, subtract 10 mm from Cotralateral Legth with Bifurcated. The 3-5 stet overlap is available oly with select limbs. Please refer to the Istructios For Use for more iformatio. AUI Proximal Product Code Desig Legth Delivery System Catheter Outer (F) ETUF C 102 E 18 ETUF C 102 E 18 ETUF C 102 E 18 ETUF C 102 E 20 ETUF C 102 E 20 ILIAC EXTENSIONS Proximal Product Code Desig Legth Delivery System Catheter Outer (F) ETEW C 82 E 14 ETEW C 82 E 14 ETEW C 82 E 16 ETEW C 82 E 16 ETEW C 82 E 18 11

12 Idicatios The Edurat II/Edurat IIs bifurcated stet graft is idicated for the edovascular treatmet of ifrareal abdomial aortic or aorto-iliac aeurysms. The Edurat II aorto-ui-iliac (AUI) stet graft is idicated for the edovascular treatmet of ifrareal abdomial aortic or aortoiliac aeurysms i patiets whose aatomy does ot allow the use of a bifurcated stet graft. The Edurat II/Edurat IIs stet graft system is idicated for use i patiets with the followig characteristics: Adequate iliac/femoral access that is compatible with vascular access techiques, devices ad/or accessories Proximal eck legth of 10 mm Ifrareal eck agulatio of 60 Aortic eck diameters with a rage of 19 to 32 mm fixatio legth(s) of 15 mm Iliac diameters with a rage of 8 to 25 mm Morphology suitable for aeurysm repair Cotraidicatios The Edurat II/Edurat IIs stet graft system is cotraidicated i: Patiets who have a coditio that threates to ifect the graft. Patiets with kow sesitivities or allergies to the device materials. Warigs ad Precautios The log-term safety ad effectiveess of the Edurat II/Edurat IIs stet graft system has ot bee established. All patiets should be advised that edovascular treatmet requires lifelog, regular follow-up to assess the health ad the performace of the implated edovascular stet graft. Patiets with specific cliical fidigs (e.g., edoleaks, elargig aeurysms or chages i the structure or positio of the edovascular graft) should receive ehaced follow-up. Specific follow-up guidelies are described i the Istructios for Use. Patiets experiecig reduced blood flow through the graft limb, aeurysm expasio, ad persistet edoleaks may be required to udergo secodary itervetios or surgical procedures. The Edurat II/Edurat IIs stet graft system is ot recommeded i patiets uable to udergo or who will ot be compliat with the ecessary preoperative ad postoperative imagig ad implatatio studies as described i the Istructios for Use. Real complicatios may occur: 1) From a excess use of cotrast agets. 2) As a result of emboli or a misplaced stet graft. The radiopaque marker alog the edge of the stet graft should be aliged immediately below the lower-most real arterial origi. Studies idicate that the dager of micro-embolizatio icreases with icreased duratio of the procedure. The safety ad effectiveess of the Edurat II/Edurat IIs stet graft system has ot bee evaluated i some patiet populatios. Please refer to the product Istructios for Use for details. MRI Safety ad Compatibility No-cliical testig has demostrated that the Edurat II/Edurat IIs stet graft is MR Coditioal. It ca be scaed safely i both 1.5T & 3.0T MR systems uder certai coditios as described i the product Istructios for Use. For additioal iformatio regardig MRI please refer to the product Istructios for Use. Adverse Evets Potetial adverse evets iclude (arraged i alphabetical order): amputatio; aesthetic complicatios ad subsequet attedat problems (e.g., aspiratio), aeurysm elargemet; aeurysm rupture ad death; aortic damage, icludig perforatio, dissectio, bleedig, rupture ad death; arterial or veous thrombosis ad/or pseudoaeurysm; arterioveous fistula; bleedig, hematoma or coagulopathy; bowel complicatios (e.g., ileus, trasiet ischemia, ifarctio, ecrosis); cardiac complicatios ad subsequet attedat problems (e.g., arrhythmia, myocardial ifarctio, cogestive heart failure, hypotesio, hypertesio); claudicatio (e.g., buttock, lower limb); death; edema; embolizatio (micro ad macro) with trasiet or permaet ischemia or ifarctio; edoleak; fever ad localized iflammatio; geitouriary complicatios ad subsequet attedat problems (e.g., ischemia, erosio, femoral-femoral artery thrombosis, fistula, icotiece, hematuria, ifectio); hepatic failure; impotece; ifectio of the aeurysm, device access site, icludig abscess formatio, trasiet fever ad pai; lymphatic complicatios ad subsequet attedat problems (e.g., lymph fistula); eurologic local or systemic complicatios ad subsequet attedat problems (e.g., cofusio, stroke, trasiet ischemic attack, paraplegia, paraparesis, paralysis); occlusio of device or ative vessel; pulmoary complicatios ad subsequet attedat problems; real complicatios ad subsequet attedat problems (e.g., artery occlusio, cotrast toxicity, isufficiecy, failure); stet graft: improper compoet placemet; icomplete compoet deploymet; compoet migratio; suture break; occlusio; ifectio; stet fracture; graft twistig ad/or kikig; isertio ad removal difficulties; graft material wear; dilatatio; erosio; pucture ad perigraft flow; surgical coversio to ope repair; vascular access site complicatios, icludig ifectio, pai, hematoma, pseudoaeurysm, arterioveous fistula, dissectio; vascular spasm or vascular trauma (e.g., iliofemoral vessel dissectio, bleedig, rupture, death); vessel damage; woud complicatios ad subsequet attedat problems (e.g., dehiscece, ifectio, hematoma, seroma, cellulitis) Please referece product Istructios for Use for more iformatio regardig idicatios, warigs, precautios, cotraidicatios ad adverse evets. CAUTION: Federal (USA) law restricts this device to sale by or o the order of a physicia. Aortic Peripheral edoveous 3576 Uocal Place Sata Rosa, CA USA medtroic.com/aortic 24-hour Techical Support Toll free: Orders Toll free: Fax: CardioVascular LifeLie Customer Support Tel: Toll free: UC a EN Medtroic All rights reserved. Medtroic, Medtroic logo ad Further, Together are trademarks of Medtroic. All other brads are trademarks of a Medtroic compay. Prited i the USA. For distributio i the USA oly. 10/16