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Flexibility and Precision in Peripheral Arteries

0.035” OTW Self- Expanding Stent System. Flexibility and Precision in Peripheral Arteries. The Reality of Femoral Occlusions. R ange of diameter Range of length Usable Catheter lengt h Guide wire compatibility Introducer compatibility Construction & design Entry profile:

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Flexibility and Precision in Peripheral Arteries

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  1. 0.035” OTW Self- Expanding Stent System Flexibility and Precision in Peripheral Arteries

  2. The Reality of Femoral Occlusions

  3. Range of diameter Range of length Usable Catheter length Guide wire compatibility Introducer compatibility Construction & design Entry profile: On-stent Tantalum markers Ø 6, 7, 8, 9, 10, 12 mm 20, 30, 40, 60, 80, 120 mm 80 cm / 120 cm 0.035” 6F multisegmented design withreinforced link-elements 0.043” 1 @ each end In Summary

  4. The Stent

  5. Basics on NiTiNOL • NiTiNOL was invented 1962 by the US-Naval Ordnance Laboratory, a department of the US-Navy. • Nickel Titanium Naval OrdnanceLaboratory • They were looking for a very hard, anti-magnetic and corrosion resistant material • They melted 45% Titanium and 55% Nickel, which developed the desired properties and even more. • NiTiNOL is a brand name, there are other NiTi-alloys with other names like • Sentinol, Sentalloy, ...

  6. What is Superelasticity?

  7. Properties of NiTiNOL • Superelasticity • In reality it is pseudo-elastic • if it is cooled down below  20°C, it becomes inelastic like pure Tin (Zn) so that it can be deformed in all facilities without breaking (Martensitic low temperature phase). If it is rewarmed above  20°C, it moves back in its previous shape. • Over 20°C it can be bended and twisted as desired and immediately it moves back to the old shape (Austenitichigh temperature phase). • Depending on the Alloy ingredients, the conversion temperature can vary from -15°C to +80°C.

  8. Shape NiTiNOL • The material needs to be fixtured and constrained in the desired shape and heat-treated. Typically for superelastic material, a heat treatment in the 500°C range is adequate; the length of heat treatment varies with the equipment used for the heat treatment and the thermal mass of the shaping fixture. In a molten salt bath for example, the heat treatment time is generally between 2 and 5 minutes.

  9. Highly flexible and conformable stent platform Laser cut, ultra-polished surfaces Multisegmented design well proven zigzag-Nitinol design oversized connecting links for improved fracture resistance Surface Quality Ultra high polished surface Increased corrosion resistance Stent Design

  10. Stent Marker • Two Tantalum markers (one on each end of the stent) for enhanced visibility • High safety, because of Laser-welded markers • Unique inside oriented marker, for improved mechanical properties • Good radiopacity of the stent • Strut thickness: 0.18 mm • Strut width: 0.13 mm

  11. Thin struts for high flexibility Expansion • Large strut width for sufficient radial strength Flexure Best Adaptability to the Vessel Dynamic Requirements Torsion • Oversized connecting links for improved fracture resistance Elongation • Adequate strut dimensions, number of links and design for dynamic adaptability Mechanical Stent Behaviour

  12. Diameter dependent number of links • Number of link elements: • 3 link-elements • Ø 6, 7 and 8 mm • 5 link-elements • Ø 9, 10 and 12 mm • Optimized radial strength and response to different mechanical stress by the diameter specific design • Oversized connecting links for improved fracture resistance. 1 3 3 1 2 2

  13. Shortening – a technical answer • Shortening is dependent from the nominal length & diameter of the stent! • When the stent is loaded in the delivery system, it is longer than the nominal length! • Since the proximal marker on the SDS is movable, the stent edges are clearly marked to enable a proper positioning in the lesion. • Even if the stent follows the sheath retraction for some mm, the distal markers stays always behind it. • We have measured a shortening of 3,9% in the worst case

  14. The Wallstent Story This mechanical behaviour is HISTORY!

  15. small  large  Metal-to Artery Ratio

  16. Stent Ø 6.0 mm length 20, 30, 40, 60, 80, 100, 120 mm Stent Ø 7.0 mm length 20, 30, 40, 60, 80, 100, 120 mm Stent Ø 8.0 mm length 30, 40, 60, 80, 100, 120 mm Stent Ø 9.0 mm length 30, 40, 60, 80, 100 mm Stent Ø 10.0 mm length 30, 40, 60, 80, 100 mm Stent Ø 12.0 mm length 30, 40, 60, 80 mm Usable Shaft Length: 80 cm and 120 cm Model Mix Stent Ø := unconstrained stent diameter length := nominal length @ unconstrained diameter

  17. The Stent Delivery System

  18. SDS Construction • OTW • 0.035” guide wire compatible • Standard guidewire size, 0.018” is more exotic • 6F shaft • General accepted size for peripheral interventions • 80 and 120 cm usable shaft length • Suitable for antegrade or contralateral approaches • Delivery by holding the stainless steel tube in place and sliding back the Y-piece with Tuohy-Borst Valve • Straight forward technique • Tuohy-Borst Valve, better known as variable hemostatic valve

  19. Radiopaque Markers on SDS • Proximal marker (1) • Proximal marker acts as the pusher to maintain the stent in place when the outer tube is retracted and the stent is deployed. • Distal marker is integrated in the outer tube (2) • Tip material is radiopaque (mixed with Barium Sulfate) (3) (1) (2) (3)

  20. SDS Sheath Construction • Full length braided sheath design • This reinforcement combines pushability and flexibility to enable easy negotiation in tortuous anatomies without kinking • ideal balance for successful contra-lateral approaches • PTFE coating inside the sheath • Reduction of friction between sheath and stent for a gradual, controlled and safe deployment of the stent in the lesion

  21. Tip Construction / Entry Profile • New Tip design entry profile of 0,043 “ (1.10 mm), • Tip composed of a corrugated tube and a radiopaque overmoulded tube • NEW: edges were rounded to avoid entrapment during retrievalNEW: security seal between white overmoulded tip and blue inner tube.

  22. The Pull-Back-Handle • We have chosen the KISS approach! Keep It Simple & Safe • Delivery by sliding back the Y-piece with Tuohy-Borst Valve while holding the stainless steel tube in place • After flushing the inner lumen of the sheath through the side port… • With one hand keep the steel tube in position, with the other hand slide back the Y-piece • It is not a “Black-Box” Handle You see - what you get/do!

  23. Stent Positioning • Controlled, precise positioning • minimal shortening to obtain an adequate lesion coverage • PTFE inner shaft coating for low-friction stent deployment • low compliant core-tube for direct transition from pull-back handle to sheath retraction

  24. Product Features • Excellent Flexibility of the Stent Platform and the Delivery System • Inside shaft Teflon-liner for low friction deployment • Optimal balance of flexibility, radial force and strut fracture resistance • Diameter dependent design • Ø 6, 7, 8 mm - 3 links • Ø 9, 10, 12 mm - 5 links • Atraumatic, kink-resistant tip design • Braided outer catheter shaft with Pull-Back Handle

  25. Clinical Data

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