When Outcomes Matter, Design Matters
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1 to receive our latest news and key activities. Cordis S.M.A.R.T. Self-Expanding Nitinol Lower Extremity Solutions When Outcomes Matter, Design Matters For superficial femoral artery (SFA) and iliac lesions. Achieve optimal patient outcomes through design. 1-year STROLL study results inside LinkedIn page Follow us on CORDIS EMEA
2 OUTCOMES MATTER Compelling outcomes in the STROLL * study The STROLL outcomes both meet and exceed our expectations for patients with symptomatic disease of the superficial femoral artery. Dr William A. Gray, Director of Endovascular Services Cardiovascular Research Foundation, New York Effective SFA revascularization through 1 year with the S.M.A.R.T. Self-Expanding Nitinol 1 Clinical outcomes at 1 year 81.7% primary patency 87.6% freedom from TLR 2.% stent fracture rate (all Type I) Patient outcomes at 1 year 76.6% of patients had minimal or no PAD symptoms 81.% of patients had normal ABI (>.8) STROLL study design 1 25 patients enrolled at 39 sites in the United States Patients in this nonrandomized, single-arm study to be followed for up to 3 years *The S.M.A.R.T. Self-Expanding Nitinol in the Treatment of Obstructive Superficial Femoral Artery Disease (STROLL) study. Cordis data on file, 212. A principal investigator of the STROLL study. Defined per Kaplan-Meier estimate, according to secondary analysis as no significant reduction in flow detectable by duplex ultrasound and no further clinically driven target lesion revascularization. Defined as Rutherford-Becker classification or 1. Reference: 1. Data on file 212, Cordis Corporation.
3 DESIGN MATTERS Designed for optimal performance Overview S.M.A.R.T. Self-Expanding Nitinol design is key Scaffolding Smaller cell size and uniform coverage can help prevent vessel prolapse. Longitudinal stability Greater stability minimizes stretching at deployment, thereby increasing placement accuracy. Radial force The stent s ability to resist compression maintains luminal gain. Unique 36 strut /6 bridge construction 36 Struts Each circumferential ring contains 36 struts, providing radial force and scaffolding. 6 Alternating Bridges Each ring is connected by 6 bridges for greater longitudinal stability. Offset Peak-to-Valley Design The offset design provides smooth lumen and stent contourability without strut overlapping or fish-scaling. Segmented Micromesh Geometry The unique micromesh design allows for consistent radial force, uniform scaffolding, and small cell size. 1
4 OUTCOMES MATTER Achieve desired clinical outcomes High primary patency rate maintained at 1 year in the STROLL study with the S.M.A.R.T. Self-Expanding Nitinol 1 Primary patency 1 8 Patency (%) %* primary patency at 1 year Time after initial procedure (months) Strong rate of freedom from clinically driven TLR maintained at 1 year in the STROLL study 1 Freedom from TLR 1 Freedom From Clinically Driven TLR (%) % freedom from TLR at 1 year Time after initial procedure (months) Reference: 1.The S.M.A.R.T. Self-Expanding Nitinol in the Treatment of Obstructive Superficial Femoral Artery Disease (STROLL) study. Cordis data on file, 212. * Defined per Kaplan-Meier estimate, according to secondary analysis as no significant reduction in flow detectable by duplex ultrasound and no further clinically driven target lesion revascularization 2
5 Provide critical patient outcomes Minimal or no signs of PAD* in 3 of 4 patients at 1 year in the STROLL study as measured using Rutherford-Becker classification 1 Rutherford-Becker classification Distribution of Patients (%) at 1 Year (no symptoms) 76.6% (mild claudication) (moderate claudication) Classification (severe claudication) (ischemic rest pain or tissue loss) Outcomes Normal ABI in 4 of 5 patients at 1 year in the STROLL study 1 81% of patients had ABI >.8 one year after deployment of S.M.A.R.T. Self-Expanding Nitinol *Defined as Rutherford-Becker classification or 1. Reference: 1. The S.M.A.R.T. Self-Expanding Nitinol in the Treatment of Obstructive Superficial Femoral Artery Disease (STROLL) Study. Cordis Data on file, 212, Cordis Corporation 3
6 DURABILITY MATTERS Experience sustained stent integrity Low fracture rate through 1 year in the STROLL study with the S.M.A.R.T. Self-Expanding Nitinol 1 fracture rate 5 Fracture Rate (%) at 1 Year none = 2. Only Type I fractures were observed in the STROLL study Type I Type II-V Any Assessing stent fractures, which may lead to adverse outcomes 2 fracture grading scale Type I One strut fracture Type II Multiple strut fractures Type III Complete transverse linear fracture Type IV Complete transverse linear fracture with displacement Type V Complete transaxial fracture Adapted from Rocha-Singh et al. 2 References: 1. The S.M.A.R.T. Self-Expanding Nitinol in the Treatment of Obstructive Superficial Femoral Artery Disease (STROLL) Study. Cordis data on file, 212, cordis corporation 2.Rocha-Singh KJ et al; on behalf of VIVA Physicians, Inc. Catheter Cardiovasc Interv. 27;69:
7 Fracture rates with other stents Severe fractures observed at 1 year with EV3 Protégé EverFlex and Bard Life EverFlex (DURABILITY I trial) 1 Fracture Rate (%) at 1 Year = 8.1 9% of all stent fractures occurred in stents that were elongated at deployment 1 Mild Moderate Severe Any Fracture Rate (%) at 1 Year Life (RESILIENT trial all phases and arms) 2, Type I 1.7 Type IV = 3.1 Any 1% of Type IV fractures occurred in stents that were elongated at deployment 2 Fracture resistance References: 1. Bosiers M et al. J Endovasc Ther. 29;16: Laird JR et al; for the RESILIENT Investigators. Circ Cardiovasc Interv. 21;3: Bard Life and Delivery System Vascular Application. Instructions for Use. Version 6. C.R. Bard Inc. December 21. 5
8 DESIGN MATTERS Statistically superior stability Up to 834% greater stability for accurate placement with the S.M.A.R.T. Self-Expanding Nitinol 1 Longitudinal stability The 6-bridge design of the S.M.A.R.T. Self-Expanding Nitinol provides superior longitudinal stability for predictable deployment Lower value =more stretchable Statistically significant difference if P< Cordis Biotronik S.M.A.R.T. Astron CONTROL (6F) Covidien Protégé EverFlex Cook Zilver Flex Cook Zilver Boston Scientific Innova Covidien EverFlex Plus Bard Life Abbott Absolute Terumo Misago Unique design provides uniform scaffolding and small cell size Cordis S.M.A.R.T. Self-Expanding Nitinol ev3 Protégé EverFlex Abbott Absolute Bard Life Cook Zilver 36 Struts/6 Bridges 32 Struts/4 Bridges 12 Struts/3 Bridges 36 Struts/4 Bridges 24 Struts/4 Bridges Reference: 1. Cordis data on file. Bench top tests performed in 26; 21, 211 and mm x 6 mm stents tested. 6
9 Unmatched radial force Up to 118% greater radial force than other nitinol stents with the S.M.A.R.T. Self-Expanding Nitinol 1 Radial force Higher value = greater radial strength Statistically significant difference if P< Cordis Bard S.M.A.R.T. Life CONTROL I Biotronik Astron (6F) Covidien Protégé EverFlex Boston Scientific Innova Covidien EverFlex Cook Zilver Flex Cook Zilver Terumo Misago Abbott Absolute Increased radial force maximizes luminal gain 2 Greater radial force = Larger lumen = More flow Flow = 16πV Flow = 25πV Flow = 36πV r = 4mm r = 5mm r = 6mm S.M.A.R.T. Self-Expanding Nitinol are designed to maintain luminal gain Vessel 1mm gain in radius = 56% greater flow 2mm gain in radius = 125% greater flow Design Reference: 1. Cordis data on file. Bench top tests performed in 26; 21, 211 and mm x 6 mm stents tested. 2. Volumetric flow rate = velocity x Pi x radius 2 7
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11 Cordis S.M.A.R.T. CONTROL Self-Expanding Nitinol Ordering Information S.M.A.R.T. CONTROL Self-Expanding Nitinol Product Description Type Material Diameters Lenght Delivery System Working Lengths MicroMesh Geometry, Segmented Design, with Delivery Handle Nitinol, with MicroMarker Technology 6-1 mm, 12 mm, 14 mm 2-1 mm, 12 & 15 mm 8 cm (S suffix) & 12 cm (M suffix) Maximum Guidewire.35" Sheath Compatibility Guide Catheter Compatibility 6F (6-1 mm), 7F (12-14 mm) 8F (6-1 mm), 9F (12-14 mm) Cordis S.M.A.R.T. s: Long 12 mm and 15 mm s 8 cm Delivery Expanded Expanded Profile: Sheath/ System Diameter (mm) Length Guide Fit (F) C612SV /8 C615SV /8 C712SV /8 C715SV /8 C812SV /8 C815SV /8 Cordis S.M.A.R.T. s: Long 12 mm and 15 mm s 12 cm Delivery Expanded Expanded Profile: Sheath/ System Diameter (mm) Length Guide Fit (F) C612MV /8 C615MV /8 C712MV /8 C715MV /8 C812MV /8 C815MV /8 Cordis S.M.A.R.T. CONTROL s: Large, 12 X 14 mm diameter 8 cm Delivery Expanded Expanded Profile: Sheath/ System Diameter (mm) Length Guide Fit (F) C123SV /9 C124SV /9 C126SV /9
12 C128SV /9 C143SV /9 C144SV /9 C146SV /9 C148SV /9 Cordis S.M.A.R.T. CONTROL s: Large, 12 X 14 mm diameter 12 cm Delivery Expanded Expanded Profile: Sheath/ System Diameter (mm) Length Guide Fit (F) C124MV /9 C126MV /9 C128MV /9 C144MV /9 C146MV /9 C148MV /9 Cordis S.M.A.R.T. CONTROL s 8 cm Delivery Expanded Expanded Profile: Sheath/ System Diameter (mm) Length Guide Fit (F) C62SV 6 2 6/8 C63SV 6 3 6/8 C64SV 6 4 6/8 C66SV 6 6 6/8 C68SV 6 8 6/8 C61SV 6 1 6/8 C72SV 7 2 6/8 C73SV 7 3 6/8 C74SV 7 4 6/8 C76SV 7 6 6/8 C78SV 7 8 6/8 C71SV 7 1 6/8 C82SV 8 2 6/8 C83SV 8 3 6/8 C84SV 8 4 6/8 C86SV 8 6 6/8 C88SV 8 8 6/8 C81SV 8 1 6/8 C92SV 9 2 6/8 C93SV 9 3 6/8 C94SV 9 4 6/8 C96SV 9 6 6/8 C98SV 9 8 6/8
13 C12SV 1 2 6/8 C13SV 1 3 6/8 C14SV 1 4 6/8 C16SV 1 6 6/8 C18SV 1 8 6/8 Cordis S.M.A.R.T. CONTROL s 12 cm Delivery Expanded Expanded Profile: Sheath/ System Diameter (mm) Length Guide Fit (F) C63MV 6 3 6/8 C64MV 6 4 6/8 C66MV 6 6 6/8 C68MV 6 8 6/8 C61MV 6 1 6/8 C73MV 7 3 6/8 C74MV 7 4 6/8 C76MV 7 6 6/8 C78MV 7 8 6/8 C71MV 7 1 6/8 C83MV 8 3 6/8 C84MV 8 4 6/8 C86MV 8 6 6/8 C88MV 8 8 6/8 C81MV 8 1 6/8 C93MV 9 3 6/8 C94MV 9 4 6/8 C96MV 9 6 6/8 C98MV 9 8 6/8 C13MV 1 3 6/8 C14MV 1 4 6/8 C16MV 1 6 6/8 C18MV 1 8 6/8 Important Information Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings, and precautions. As part of the Cordis policy of continuous product development, we reserve the right to change product specifications without prior notification. For healthcare professionals only. 217 Cardinal Health. All Rights Reserved. CORDIS, Cordis LOGO and S.M.A.R.T CONTROL are trademarks of Cardinal Health and may be registered in the US and/or in other countries. EU237 6/17.
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