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Isthmus Logic CoCr Balloon Expandable Stent for Iliac Arteries DS - PowerPoint PPT Presentation

Jun 04, 2023 •47 likes •287 views

Isthmus Logic CoCr Balloon Expandable Stent for Iliac Arteries DS - 2018 Isthmus Logic Uniform increased radial force and excellent scaffolding with a unique cell architecture, ideal for calcified lesions. Platinum markers with no stent

  1. Isthmus Logic CoCr Balloon Expandable Stent for Iliac Arteries DS - 2018

  2. Isthmus Logic  Uniform increased radial force and excellent scaffolding with a unique cell architecture, ideal for calcified lesions.  Platinum markers with no stent foreshortening allow unmatched placement accuracy and visualization as needed in iliac stenting.  6F introducer sheath compatibility for all sizes due to the state of the art technology applied on both stent and balloon catheter.  Proven biocompatibility enabled by the Bio Inducer Surface coating accelerating the rate of endothelialization and strut coverage, reducing the thrombogenity.

  3. Isthmus Logic  Uniform increased radial force and excellent scaffolding with a unique cell architecture, ideal for calcified lesions.  Platinum markers with no stent foreshortening allow unmatched placement accuracy and visualization as needed in iliac stenting.  6F introducer sheath compatibility for all sizes due to the state of the art technology applied on both stent and balloon catheter.  Proven biocompatibility enabled by the Bio Inducer Surface coating accelerating the rate of endothelialization and strut coverage, reducing the thrombogenity.

  4. Isthmus Logic Homogeneous scaffolding: Isthmus Logic is available in 2 stent designs to offer a homogeneous performance in term of geometry of the expanded cell, radial force and vessel coverage from 6 mm to 10 mm Nominal Diameter N. of cells per Strut thickness [mm] circunference [micron] 6 – 8 8 cells 175 9 – 10 9 cells 175

  5. Isthmus Logic Homogeneous scaffolding versus post-dilatation: Isthmus Logic can be post-dilated to the final diameters listed below without changes in mechanical properties (i.e. radial force, scaffolding). Nominal Diameter N. of cells per Strut thickness Max diameter in [mm] circunference [micron] post-dilatation [mm] 6 – 8 8 cells 175 9 9 – 10 9 cells 175 11 Other competitors give the maximum “theoretical” expansion in which the stent does not break, but the stent loses its mechanical performance in overexpanded configuration.

  6. Isthmus Logic Homogeneous scaffolding and Radial Strenght: +43% +25% R&D test radial force

  7. Isthmus Logic  Uniform increased radial force and excellent scaffolding with a unique cell architecture, ideal for calcified lesions.  Platinum markers with no stent foreshortening allow unmatched placement accuracy and visualization as needed in iliac stenting.  6F introducer sheath compatibility for all sizes due to the state of the art technology applied on both stent and balloon catheter.  Proven biocompatibility enabled by the Bio Inducer Surface coating accelerating the rate of endothelialization and strut coverage, reducing the thrombogenity.

  8. Isthmus Logic Radiopaque markers & No foreshortening: One platinum marker at each stent end Midpoint connections avoid any FORESHORTENING upon stent expansion

  9. Isthmus Logic BE Iliac Stents are generically selected, due to theirs features, in situations like: • Ostial implants (to Aorta) • Kissing stent (for Aorto-iliac bifurcations) • Focal lesion

  10. Isthmus Logic The 2 platinum markers , located at both stent ends, provide exceptional visibility and contribute to guarantee perfect placement in particular @ the ostium of the iliac artery. Once the stent is correctly positioned, the flexible links connected to the mid point of the sinusoids allow ZERO fore shortening upon expansion preserving the original stent length.

  11. Isthmus Logic  Uniform increased radial force and excellent scaffolding with a unique cell architecture, ideal for calcified lesions.  Platinum markers with no stent foreshortening allow unmatched placement accuracy and visualization as needed in iliac stenting.  6F introducer sheath compatibility for all sizes due to the state of the art technology applied on both stent and balloon catheter.  Proven biocompatibility enabled by the Bio Inducer Surface coating accelerating the rate of endothelialization and strut coverage, reducing the thrombogenity.

  12. Isthmus Logic CoCr stent struts: Insthmus Logic flexibility has been increased thanks to the design and the reduction of the stent thickness to 175 micron. Strut Section Strut thickness 175 micron Cobalt Chromium

  13. Isthmus Logic Delivery system Over the wire (OTW) catheter Catheter Length: 75/135 cm Compatibility: Guidewire 0.035” /Introducer sheath 6F Material: Polyamide Diameter: 1,71 mm (5.1 French) Shaft Design: single body - dual lumen

  14. Isthmus Logic  Uniform increased radial force and excellent scaffolding with a unique cell architecture, ideal for calcified lesions.  Platinum markers with no stent foreshortening allow unmatched placement accuracy and visualization as needed in iliac stenting.  6F introducer sheath compatibility for all sizes due to the state of the art technology applied on both stent and balloon catheter.  Proven biocompatibility enabled by the Bio Inducer Surface coating accelerating the rate of endothelialization and strut coverage, reducing the thrombogenity.

  15. The Bio Inducer Surface (BIS) This 2 nd generation pure carbon coating (≤0.3 µm) brings the crystalline structure closer to the diamond structure with a further improvement of its bio/haemo compatibility The Bio-Inducer Surface is made of pure carbon atoms Bio/haemo-compatibility % % Graphite Diamond

  16. The Bio Inducer Surface (BIS) Iliac artery stenosis are mainly located in the ostial segment and have a high rate of restenosis due the characteristics of the lesion (extremely calcified) and due the blood flow turbulences present in the segment where the iliac artery is located. The positive contribution of the Bio Inducer Surface coating features should reduce the restenosis rate.

  17. The Bio Inducer Surface (BIS) Time Foreseen clinical impact* Bio Inducer Surface BMS Day 0 Thrombo-resistant Pro-thrombotic surface surface Day 3 Partially endothelialized + Pro-thrombotic surface thrombo-resistant surface Day 7 Endothelialized surface Partially endothelialized + pro-thrombotic surface * Slide pictures are of a purely illustrative nature and are not intended to depict reality

  18. Isthmus Logic  Uniform increased radial force and excellent scaffolding with a unique cell architecture, ideal for calcified lesions.  Platinum markers with no stent foreshortening allow unmatched placement accuracy and visualization as needed in iliac stenting.  6F introducer sheath compatibility for all sizes due to the state of the art technology applied on both stent and balloon catheter.  Proven biocompatibility enabled by the Bio Inducer Surface coating accelerating the rate of endothelialization and strut coverage, reducing the thrombogenity.

  19. Product specifications PERIPHERAL STENT Stent Diameters: 6 - 10 mm Stent Lenghts: 19 - 59 mm Stent material: L605 CoCr alloy Strut surface coating: Bio Inducer Surface 2 platinum radiopaque markers at stent ends No stent foreshortening upon expansion DEVICE SPECIFICATIONS Over The Wire (OTW) Introducer sheath compatibility: 6F Guidewire compatibility: 0.035" Usable Catheter Lenght - UCL: 75 & 135 cm Nominal Pressure: 7 - 8 atm Rated Burst Pressure: 10 - 12 atm

  20. Available codes

  21. Clinical Focus The Clinical Focus has the objective to present how challenging cases have been treated by recognized European KOLs with the implantation of Isthmus Logic stents in order to show the benefits this device can bring to patients.

  22. Clinical Focus The best feedbacks we can have about Isthmus Logic comes from the users: Isthmus Logic balloon expandable stent offers a good scaffolding and with one marker at each end allows a precise positioning. This stent is also offering a unique technology of the Bio Inducer Surface,a pure carbon coating, reducing thrombogenicity and increasing Endothelization . Common iliac arteries repair needs balloon expendable stents with good profile, high radial forces, good trackability. Isthmus Logic cobalt-chrome stents are 6F compatible for all sizes and combined all these avantages to achieve endovascular treatment of common iliac arteries plus a Bio Inducer Surface technology reducing thrombogenicity.

  23. Clinical Focus The Isthmus Logic balloon expandable stent is a well designed stent which offers adequate radial forces to overcome severe and calcified iliac stenosis. The stents can be placed very accurately without unwanted shortening and have good visualization on fluoroscopy due the radiopaque markers on both ends, all essential characteristics for stents, especially in procedures like bilateral common iliac stenting. The carbon coating reduces the risk of restonosis and facilitate in long lasting patency. The 10 mm diameter Isthmus Logic stent is compatible with a 6 Fr introducer, which contributes in reducing the risk of puncture site-related haemorrhagic events and discharging the patient within the same day. In our experience Isthmus Logic stent has an accurate deployment with no foreshortening and provides sufficient radial force for the treatment of severe iliac atheromatic disease.

  24. www.alvimedica.com 23

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