W e m a k e i d e a s c o m e a l i v e 001SCB For internal use only Peripheral Co-Cr Stent System OTW On the cutting edge of flexibility and strength

Pelvic vessels 1 Aorta abdominalis 1a,1b A. lumbales 1c A. sacralis mediana (Aorta caudalis) 1d Aa. sacrales 2 A. iliaca communis 3 A. iliaca interna 3a A. obturatoria 3b A. glutealis superior 3c A. glutealis inferior 3d A. pudenda interna 3e A. vesicalis inferior 3f A. rectalis medialis 3g A. vesicalis superior 3h A. iliolumbalis 4 A. iliaca externa 4a A. circumflexa iliaca profunda 5 A. femoralis communis 5a A. circumflexa femoris medialis 5b A. circumflexa femoris lateralis 6 A. profunda femoris (A. femoralis profunda)

W e m a k e i d e a s c o m e a l i v e 001SCB For internal use only Balloon-expandable Stents Pro and Contra in iliac lesions Pro precise deployment High radial force Suitable highly calcified short, focal lesions Primary stenting possible, kissing/hugging stent technique in the aortic bifurcation Optional oversizing No need of an extra PTA balloon for postdilatation Contra Lower flexibility for contralateral approaches Crushability Not suitable for long diffuse lesions Risk of losing the stent when crossing calcified lesions Should be covered by a guiding catheter or similar

W e m a k e i d e a s c o m e a l i v e 001SCB For internal use only Decision between SE or BE stents in Iliac lesions Balloon expandable Aortoiliac bifurcation Common iliac Calcified lesions Chronic occlusions (?) Self expanding Tortuous vessels Distal external iliac artery Contralateral approach Long diffuse lesions Aortoiliac bifurcation (long lesions) John R. Laird; Cardiovascular Research Institute Washington Hospital Center; TCT 2001

William A. Gray MD, LINC 2007

W e m a k e i d e a s c o m e a l i v e 001SCB For internal use only The situation… …Occlusion of the left common Iliac artery

W e m a k e i d e a s c o m e a l i v e 001SCB For internal use only The treatment Kissing/Hugging Balloon/Stent Technique

W e m a k e i d e a s c o m e a l i v e 001SCB For internal use only Result could be like that…

W e m a k e i d e a s c o m e a l i v e 001SCB For internal use only How to get around the horn ? Its all about deliverability…

W e m a k e i d e a s c o m e a l i v e 001SCB For internal use only First Cobalt-Chromium peripheral Stent, mounted on a 5F Delivery system

W e m a k e i d e a s c o m e a l i v e 001SCB For internal use only The Stent

W e m a k e i d e a s c o m e a l i v e 001SCB For internal use only History of Co-Cr Co-Cr was used since 1937 in medical implants: more than 30 years of usage in humans Cage for heart valves Endo-prosthesis Aneurysm clips Pacemaker leads Co-Cr more biocompatible, stronger, less ferromagnetic, more resistant to fatigue and corrosion than Stainless Steel

W e m a k e i d e a s c o m e a l i v e 001SCB For internal use only Scientific Results Co-Cr Co-Cr is STRONGER than Stainless Steel Lower thickness without decreasing radial force Co-Cr is around 45% stronger than Stainless Steel Co-Cr is DENSER than Stainless Steel Good radiopacity despite thinner struts Co-Cr is around 6% denser than Stainless Steel MaterialKg per m 3 Cobalt alloy L SS7.944

W e m a k e i d e a s c o m e a l i v e 001SCB For internal use only Specification Stent Stent design Range of diameter Range of length Stent material Strut thickness Strut width Closed cell, slotted tube in diameter specific design Ø 5, 6, 7, 8, 9, 10 mm 18, 30, 37, 55, 75 mm Cobalt Chromium 120 µm (5 – 7 mm) 152 µm (8 – 10 mm) 120 µm (5 – 10 mm) Strut thickness 120 m for 5.0 / 6.0 / 7.0 mm Strut thickness 152 m for 8.0 / 9.0 / 10.0 mm

W e m a k e i d e a s c o m e a l i v e 001SCB For internal use only Metal-to-Artery Ratio small large

W e m a k e i d e a s c o m e a l i v e 001SCB For internal use only Stent Design Cobalt Chromium Slotted Tube, Laser cut Closed cell design Round edges, ultra-polished surfaces High flexibility of the crimped stent High radial force and longitudinal flexibility after deployment

W e m a k e i d e a s c o m e a l i v e 001SCB For internal use only The Stent Delivery System

W e m a k e i d e a s c o m e a l i v e 001SCB For internal use only Specification SDS Catheter design Guide wire compatibility Usable shaft length Balloon material Coating Shaft diameter Tip entry profile Introducer compatibility Introducer compatibility Nominal pressure RBP Over the wire, dual lumen shaft , 130 cm FLEXITEC Xtreme none5F F (Ø 5 – 9 mm) 7F (Ø 10 mm) 9 bar 17 bar

W e m a k e i d e a s c o m e a l i v e 001SCB For internal use only SDS Type / Construction NEW shaft material for improved pushability and kink resistance combined with excellent flexibility for contro-lateral maneuvers NEW balloon material FLEXITEC Xtreme for improved flexibility and extreme scratch resistance while maintaining high RBP NEW tapered tip design NEW balloon 6-folding for perfect re-wrapping, even after high pressure stent deployment NEW packaging for facilitated product handling

W e m a k e i d e a s c o m e a l i v e 001SCB For internal use only Introducer Sheath Compatibility 6F 7F for Ø 5, 6, 7, 8, 9 mm for Ø 10 mm

W e m a k e i d e a s c o m e a l i v e 001SCB For internal use only Key Selling Points First Peripheral Cobalt Chromium Stent System, for unlimited deliverability and flexibility in contralateral approaches. First Peripheral Cobalt Chromium Stent System, for unlimited deliverability and flexibility in contralateral approaches. Closed Cell Design, for tight, predictable scaffolding and appropriate radial force in Iliac lesions. Closed Cell Design, for tight, predictable scaffolding and appropriate radial force in Iliac lesions. Zero stent shortening, for precise placement Zero stent shortening, for precise placement High performance balloon material, High performance balloon material, featuring Flexitec Xtreme Polyamide, for high pressure stent deployment while maintaining high flexibility and scratch resistance. 6 balloon folding, for homogeneous stent deployment and safe retrieval of the delivery system.

W e m a k e i d e a s c o m e a l i v e 001SCB For internal use only Model Mix Stent Ø/Length 18 80/130cm 30 80/130cm 37 80/130cm 55 80/130cm 75 80/130cm

W e m a k e i d e a s c o m e a l i v e 001SCB For internal use only What are the improvements of compared to ?