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F . SETACCI (Roma)

F . SETACCI (Roma). XII Congresso Nazionale, Bari 15-17 Ottobre 2013. Nuovo disegno per uno stent nel trattamento delle steno-ostruzioni dell’asse femoro -popliteo Francesco Setacci Vascular and Endovascular Surgery Unit Department of surgery “ P.Valdoni ”

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F . SETACCI (Roma)

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  1. F. SETACCI (Roma)

  2. XII Congresso Nazionale, Bari 15-17 Ottobre 2013 Nuovo disegno per uno stent nel trattamento delle steno-ostruzioni dell’asse femoro-popliteo Francesco Setacci Vascular and EndovascularSurgery Unit Department of surgery “P.Valdoni” “Sapienza” University of Rome, Italy Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  3. Background Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  4. Background Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  5. Background

  6. Background Mean follow-up 51 months: patency 77% with a 70% Full functionary capacity of legs Czerny M et al., EJVES, 2004;27:635-639 Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  7. The SFA applies dynamic forces SFA Challenges Shortening Increased Curvature Twist Flexion Klein et al.Catheter Cardiovasc Interv 2009 Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  8. Endovascular approach to SFA • Drugs • SAP • Bare Stents • Covered stents • DES • DEB • Brachitherapy • Cryoplasty • CBA • Debulking Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  9. Stent Pattern Examples Absolute Pro Smart Control E-Luminexx Lifestent Everflex Zilver Flex1 Wallstent 1-Zilver Flex stent used as stent platform for Zilver PTX Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  10. Stent Design Decisions: Design Elements Connecting Link Crests Radius Cell Ring Length of Bar Arms Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  11. Stent Selection • AntomicalConsiderations • Lesion location • Degree of calcification • Stent performance • Availability of sizes • Introducerperformarce • Data on long termpatency • Data on fractureresistance • -Price Adapted from Th. Zeller 2007 Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  12. New stent S.M.A.R.T.® Flex Vascular Stent System Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  13. New stent The fully connected design of S.M.A.R.T.® Flex Stent is different and unique from other stents on the market today… • S.M.A.R.T.® Flex Stent is a fully connected, yet highly flexible, laser cut Nitinol self-expanding stent. • Helical Strut Bands are interconnected by Flex Bridges. • Diameter specific design to maximize performance. • 4 Radiopaque markers distally, 5 Radiopaque markers proximally. Flex Bridges Helical Strut Bands Radiopaque Markers Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  14. S.M.A.R.T Flex Stent interconnected by Flex Bridges Helical Strut Bands Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  15. S.M.A.R.T Flex Stent • Diameter specific design to maximize performance • 5 & 6 mm ø S.M.A.R.T. ® Flex Stent: • 13 bridges • 26 struts (32 struts on end rings) • 7 & 8 mm ø S.M.A.R.T. ® Flex Stent: • 16 bridges • 32 struts (34 struts on end rings) • High radial strength for all diameter sizes. • Good metal / tissue ratio for all ø sizes. • Optimal scaffolding in various types of anatomy. Vascular and EndovascularSurgery Unit - Rome

  16. S.M.A.R.T Flex Stent Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  17. S.M.A.R.T Flex Stent Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  18. S.M.A.R.T Flex Stent Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  19. Unsupported Surface Area (USA) • USA: Total area enclosed within a stent cell • Indicator of overall scaffolding Cell Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  20. S.M.A.R.T Flex Stent S.M.A.R.T.® Flex Stent has equal RRF to S.M.A.R.T.® Stent and a greater ability to resist compression and maximize luminal diameter, enabling increased blood flow. Cordis S.M.A.R.T.® Flex Vascular Stent System Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  21. S.M.A.R.T Flex Stent S.M.A.R.T.® Flex Stent demonstrates 10 times greater fracture resistance* than tested competitive stent platforms Cordis S.M.A.R.T.® Flex Vascular Stent System Cook Zilver Stent** Bard LifeStent® Stent Abbott Absolute™Stent Covidien EverFlex+TM Stent Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  22. S.M.A.R.T Flex Stent Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  23. S.M.A.R.T Flex Stent S.M.A.R.T.® Flex Stent fully connected design provides exceptional stability that can help reduce stent stretching during deployment, thereby increasing placement accuracy and achieving the intended radial force and scaffolding. Cordis S.M.A.R.T.® Vascular Stent System Cordis S.M.A.R.T.® Flex Vascular Stent System Bard LifeStent® Stent P<0001 Cook Zilver Flex™ Stent P<0001 Covidien EverFlex+TM Stent P<0001 Abbott Absolute™Stent P<0001 Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  24. S.M.A.R.T Flex Stent S.M.A.R.T.® Flex Stent lower chronic force results in low stent deployment forces, contributing to the ease and accuracy of placement Cook Zilver Stent P<0001 Abbott Absolute™Stent P<0001 Bard LifeStent® Stent P<0001 Covidien EverFlex+TM Stent P<0001 Cordis S.M.A.R.T.® Vascular Stent System Cordis S.M.A.R.T.® Flex Vascular Stent System Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  25. S.M.A.R.T Flex Stent 7 5 9 2 6 1 8 6 10 3 2 1 4 • 6 Fr Outer Sheath • Catheter tip • Inner Catheter • Guide wire lumen Tuohy-Borst valve Pusher tube Handle Female luer Luer hub Self expanding stent Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  26. S.M.A.R.T Flex Stent The stent pod contains three markers • Thedistaland most proximalare the constrained tantalumstent markers • TheProximal Placement Marker represents the target proximal stent location enable predictable foreshortening Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  27. S.M.A.R.T Flex Stent The current S.M.A.R.T.® Flex Stent SDS facilitates precise distal placement withpredictable proximal foreshortening When stent is oversized ~1mm, proximal end of stent will land close to Proximal Placement Marker (12) If vessel is smaller, stent will be longer when deployed, but cannot be any longer than Proximal Stent Markers. Predictable Foreshortening Precise Distal Placement Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  28. S.M.A.R.T Flex Stent Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  29. OPEN Trial * Dr. Gray’s presentation at CX, 2013. clinical trials.gov/ct2/show/NCT01355406?term=flexstent@rank =1 Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  30. OPEN Trial inclusion criteria • Male or female; age 35 to 80 at the time of consent. • Patient must understand purpose of study and be willing to adhere to the study requirements. • Rutherford Classification Category 2-4 • De novo lesion in the femoropopliteal artery, including the entire extent of the SFA and the proximal portion of the popliteal artery extending to the medial condyle 3 cm above the knee joint. • Disease segment length ≤ 145mm

  31. OPEN Trial inclusion criteria • >70% diameter stenosis and/or occlusion based on site-determined visual angiography • Patent ipsilateral iliac artery • Patency of ipsilateral mid/distal popliteal artery and at least 1 tibial artery with no planned intervention • Target reference vessel diameter 3.5-7.5 mm. • Projected life expectancy of 12 months or greater • Patient is available for follow-up for 36 months and is willing and able to comply with all follow-up requirements • Patient is willing and able to provide signed informed consent

  32. Lower limit of stent placement in the proximal popliteal artery Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  33. Trial Compliance No complaints or study device malfunctions reported to date!

  34. S.M.A.R.T Flex Stent Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  35. Summary • The SMARTFlex stent represents a novel nitinol stent design • Initial outcomes from FIM experience demonstrate good clinical outcomes and excellent safety and durability profile • The OPEN study will expand the knowledge base for the SMARTFlex and is intended to also demonstrate associated improvement in clinical outcome measurements Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  36. Summary • More than 2.300 stent implantend in 18 weeks Vascular and EndovascularSurgery Unit –Umberto I Hospital - Rome

  37. Vascular and Endovascular Surgery Unit - Siena

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